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  • Perspect Clin Res
  • v.2(2); Apr-Jun 2011

Good documentation practice in clinical research

Chitra bargaje.

Department of Clinical Trials and Safety, Global Quality and Regulatory Compliance, Bristol Myers Squibb, Mumbai, India

One of the most common inspection findings in investigator site inspections is lack of reliable, accurate and adequate source documentation. This also happens to be the most common pitfall identified during sponsor audits. The importance of good documentation practice needs to be emphasized to investigator sites to ensure that the study results are built on the foundation of credible and valid data. This article focuses on the key principles of good documentation practice and offers suggestions for improvement.

INTRODUCTION

Inadequate/inaccurate case histories form the second most commonly cited deficiency in US-FDA inspections of clinical investigator sites.

Similarly, source documentation issues ranked 5th among the top 10 findings from European Medicines Agency (EMA) inspections of investigator sites in 2009[ 1 ] and in some instances the findings were classified ‘critical’. Not surprisingly, clinical trial monitors and auditors also report documentation issues as a frequent area of GCP concern.

I would like to share an experience at a recent investigator site audit.

During the audit opening meeting we were informed that all the source data is on paper and no electronic documentation is used. The site was actually using MS word to document the data collected during the study. In normal practice the site did not use MS word to generate medical records. This method was adopted only for clinical trial subjects. For the trial subjects there were no other hand-written progress notes which the site would normally use for routine patients.

There were two underlying potential issues here:

  • First, the site was following a different practice for documenting progress for clinical research subjects. Were the subjects’ records missing any elements of standard care because of the deviation from routine practice?
  • Second, the site thought they had no electronic documentation, although MS word was used to record all subject data.

This example, illustrates a common occurrence in clinical trial research where a lack of understanding of basic GCP principles may have a negative impact on the quality of the study.

WHAT IS THE PURPOSE OF SOURCE DOCUMENTATION?

To understand the importance of good source documentation we should first review the purpose of source documentation. The most important purpose of source documentation in a clinical trial is to reconstruct the trial as it happened. It should enable an independent observer to reconfirm the data. Documentation should be such that it is able to provide audit trail to permit investigation if and when required.

Source documentation is the medical record of the subject before, during and after the trial.

It is the tool which confirms the eligibility criteria of the subject in the given trial.

It documents the progress of the subject from consenting till the subject completes the study. It records the accountability of the investigational product dispensed, consumed and returned by the subject. It serves as the complete medical record of the subject as the reference to the treating physician at any point of time.

Finally it forms a strong foundation for the data that gets transcribed into a CRF which ultimately gets translated into a clinical study report.

Irrespective of clinical trial, accurate documentation supports the fundamental principle of protecting subject’s rights, safety and well-being.

There can not be two thoughts to emphasize the need for reliable and quality documentation.

PRINCIPLES OF GOOD DOCUMENTATION PRACTICE

So, what does it mean when we say ‘Good Documentation’ and how do we practice it?

Any basic training in clinical research will definitely include these phrases:

‘What is not documented is not done!’

‘Document what is done as well as what is not done!’

Roots of good documentation principles are in the ICH-GCP where source data and source document is first defined.

ICH E6 1.51 source data

All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original records or certified copies).

The words in italics describe some inherent qualities of source data.

ICH E6 1.52 source documents

Original documents, data and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects’ diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate copies, microfiches, photographic negatives, microfilm or magnetic media, X-rays, subject files, and records kept at the pharmacy, at the laboratories and at medico-technical departments involved in the clinical trial).

This definition describes the various types of documents which collectively form the source document.

Key attributes for good documentation were first described by US-FDA in the form of ALCOA -attributable, legible, contemporaneous, original and accurate. These are also adapted by World Health Organization (WHO). These criteria evolved with time. EMA has added some more ‘letters’ to describe qualities of good source documentation particularly for electronic documentation.[ 2 – 4 ]

Let‘s look at these attributes described by different authorities collectively.

Attributable

It should be clear who has documented the data.

Readable and signatures identifiable.

Contemporaneous

The information should be documented in the correct time frame along with the flow of events. If a clinical observation cannot be entered when made, chronology should be recorded. Acceptable amount of delay should be defined and justified.[ 4 ]

Original, if not original should be exact copy; the first record made by the appropriate person. The investigator should have the original source document.

Accurate, consistent and real representation of facts.

Long-lasting and durable.

Available and accessible

Easily available for review of treating physicians and during audits/inspections. The documents should be retrievable in reasonable time.

Complete till that point in time.

Demonstrate the required attributes consistently.

Based on real and reliable facts.

Corroborated

The data should be backed up by evidence.

Interestingly, it should be noted that the Drug Controller General India (DCGI) would emphasize on the condition in addition to the completeness, legibility and accessibility of investigator source data file as noted in DCGI’s guidance document for inspections.[ 5 ] My understanding of ‘condition’ is the state of the source documents, in terms of filing, storing and readability.

The degree to which the data fulfills the data quality criteria establishes acceptability of the data. It also determines the degree of excellence of the data quality. Qualities like consistency, credibility and corroboration help establish data integrity along with the data quality.

These are the expectations from clinical trial documentation however in reality many issues are observed in terms of quality of source documentation.

COMMON FINDINGS WITH RESPECT TO SOURCE DOCUMENTATION

‘Failure to maintain adequate and accurate case histories that record all observations and other data pertinent to the investigation on each individual administered the investigational drug or employed as a control in the investigation’ is cited in 6 out of the 10 warning letters issued by US-FDA to clinical investigators in 2010.[ 6 ]

At one investigator site source documents were not available because the computer ‘crashed’ . So in the absence of availability, adequacy of the records could not be evaluated. The investigator was warned for ‘failure to retain records required to be maintained for the required timeframe per regulations’ .

I would like to highlight some of the findings from the warning letters in detail here. These findings give an idea of regulatory expectations and lacunae in documentation noted during inspections. I am sure readers would be able to relate to some of these findings with their personal experience.

  • Eligibility criteria could not be confirmed. For e.g., (a)IVRS user manual states “Complete call worksheets prior to contacting the IVRS; then file completed worksheets with each subject’s source documentation.” The IVRS worksheets were not kept in the subjects’ files or maintained at the site and as such it could not be confirmed that patients were stratified in the right arm and received the medication they were assigned to. (b) All the items in the exclusion criteria checklist are checked except for the exclusion criterion related to the history of thrombocytopenia, including heparin-induced thrombocytopenia, or a platelet count <100,000 cells/microliter. In the absence of lab report this exclusion criteria could not be confirmed on the basis of the incomplete checklists.
  • Multiple records for same data points making it unable to determine which served as the accurate source record, for e.g., multiple versions of visual analog scales completed for same visit with different values.
  • Discrepancies in records to confirm primary efficacy endpoint of the study, for e.g., the total administered dose of morphine, as reflected in hospital records was different from the Case Report Form. The primary efficacy endpoint of the protocol was to measure the reduction in the requirement for morphine use in the 24 hours following surgery measured by total morphine usage compared to placebo.
  • Clinical significance for out of range lab values not documented on the lab reports or conflicting information found in the source documentation-e.g., significant high glucose value marked as clinically nonsignificant on the lab report although the subject was referred to for primary physician for further follow-up.
  • Missing pages from subject interview scales, numerous unexplained corrections months after the initial entries and conflicting information; incorrect subject identifiers, incorrect date e.g., same date on screening visit, visit week 1 and week 4.
  • Numerous AEs not reported in CRFs, delays in transcribing data in CRFs, discrepancies between source and the CRF. Lack of timely reporting of AEs in eCRFs jeopardizes subject safety and reliability and integrity of data captured at the site.
  • Incorrect/incomplete documentation regarding the disposition of drugs-dates, quantity and use by subjects.

Although some of these issues may appear minor prima facie such as some checkboxes not checked, a lab report not marked for significance for out of range value, some discrepancies in source and CRF, unexplained corrections, these issues point toward lack of understanding of good documentation requirements. For an independent observer such data would fail to provide confidence and assurance of data quality and safety of the subjects enrolled. The data may be deemed unfit for use. All exposure of patients to new drugs and the efforts and time spent by the investigator team would be wasted.

Systematic deficiencies in documentation can lead to questions about the integrity of the data, potentially resulting in health authority decisions to exclude the data from analysis.

In essence, we can definitely say that the quality of documentation can make or break the study at a given site.

WHAT ARE THE POSSIBLE ROOT CAUSES FOR REPEATED DEFICIENCIES IN SOURCE DOCUMENTATION?

Clinical research documentation involves a variety of documents from various sources and is often completed by several people. Thus rendering this process to be complicated and posing challenges to meet requirements. Moreover clinical research happens over a long period of time which adds to the challenge of maintaining continuity in the documentation practice.

Inadequacies in documentation could be the result of lack of training and experience in good understanding of clinical research and documentation requirements. As a result the principal investigator (PI) and staff may continue documentation per the routine medical practice. In India, the documentation in routine medical practice may not be as extensive as what would be expected for clinical research.

Additional unmonitored medical records are discovered at the time of audits/inspections. Such as: Diaries of coordinator, inpatient records of the hospital, electronic records, etc., for the simple reason that the staff does not realize that these form a part of source record. These unmonitored records may have important data which do not find its way to the CRF. This would have an impact on the availability of important information in CRFs. Reliability and integrity of data might me affected as a result.

In many FDA warning letters one can observe that inadequate case histories, consenting or drug disposal records are often attributed to the lack of investigator’s supervision in ensuring compliance. The PI delegates responsibilities to the study team and may not provide adequate time to review the source data due to lack of time or commitment. The study documentation is completely left on the shoulders of study coordinator’s.

Various tools are used for data collection. At times sponsor provides source document worksheets to ensure complete documentation. If these worksheets are not designed accurately to align with the protocol and CRF source data quality is directly impacted. These worksheets are often completed as checkboxes without any additional notes, comments or supporting documents. Source document worksheets sometimes also result in multiple records. The sites continue to maintain the clinical practice routine documentation and worksheets are completed in addition for the study. As such, these worksheets are no longer a primary source and thus no source document.

Workload of the existing staff can be another important reason leading to poor documentation. This may cause errors like source data for one subject entered in another subject record, pages misfiled, use of incorrect consent forms and similar issues.

Study coordinator/PI work with various sponsors/CROs at a time. These different sponsors/CROs communicate different level of expectations regarding source documentation. If the site is not experienced enough and they do not have a standard procedure to follow they may get confused with variations in guidance they receive. This may negatively impact the quality of data.

Certain technical inadequacies may also lead to poor source documentation. For e.g., the ECG machine is old and does not print the date, time and subject identifiers, printer or fax machine does not work. If the fax is not working it may result in not receiving important data i.e., lab reports, data queries, investigational product allocation confirmations, SAE transmission confirmations, etc. Important email correspondence with sponsor/CROs if not printed and archived may get lost.

HOW CAN THE DOCUMENTATION BE IMPROVED?

Based on the various causes noted above, I would like to offer some suggestions to improve the quality of source documentation at sites.

  • PI should delegate responsibilities to staff adequately trained in protocol and GCP. Particular training should be provided on ALCOA and other good documentation practice requirements. Medical decisions should be delegated to medically qualified staff. Training of site staff should be repeated at defined frequency. New hires should be adequately trained before trial participation.
  • PI should commit for involvement, and supervision throughout the entire duration of the study. There should be an agreed and documented procedure for PI to ensure supervision of the study by meetings with site staff, monitors; review of documentation, timely resolution of medical, ethical or GCP issues. The PI or designated subinvestigators should validate the medical data. The PI should also supervise the work of SMO staff and external facilities if used. In case there are performance issues with SMO staff or external facility PI should immediately inform the supervisor as well as sponsor.
  • Site should develop a SOP for good documentation. This SOP should be shared with the sponsor/CRO and agreed upon before the start of the trial. This SOP should address aspects including but not limited to consenting process, verifying eligibility, use of right tools such as diaries, source document worksheets, OPD papers, copies of prescriptions, etc; ways to avoid multiple records and in case of multiple records should define the source for the study, method of corrections, review of safety labs and other reports. Documented procedure at site level should encompass management, maintenance, archival and retrieval of source documentation. Sites should have measures for continuous improvement and maintaining high-quality data. Sites should develop process for quality control.
  • Before the trial commences all technical aspects such as for e-CRFs, fax, printers, etc. should be clarified and issues resolved. In case of any difficulties during the trial, sponsor should be informed and back-up plans agreed upon till the issue is resolved. In case when original lab records or investigational records are sent to central location for assessment, process should be in place to ensure a duplicate copy or certified copy is available in the site source records.
  • Sponsor/CRO also plays an important role in ensuring quality of source documentation. Sponsor/CRO should ensure PI’s commitment and involvement throughout the study. Sponsor/CRO should assess the site’s documentation practice during pre-study visit and during the study; provide training to the site staff to reinforce expectations. Time spent effectively during pre-study evaluation on source documentation would help a great deal to minimize documentation issues later. The source data and their respective capture methods should be clearly defined prior to trial recruitment i.e. in the protocol or study specific source data agreement.

CONCLUSIONS

Source documentation should demonstrate the ALCOA and other attributes as described by regulatory authorities and GCP. Source documentation related findings are the most commonly cited during inspections and audits. PI’s commitment and involvement in the trial makes a huge difference. Efforts to train the sites, understand the sites practices right from the pre-study visit and continuous monitoring and training would definitely help in improving and maintaining the quality of site source documentation practices.

Ultimately the source document should speak for itself. It should narrate the medical journey of the patient as it happened to an independent observer-an auditor or inspector and thus form a strong foundation for a good clinical research.

Acknowledgments

I would like to thank Jessica Parchman (Group Director) and Kristel Van De Voorde (Director) from Global Quality and Regulatory Compliance, Bristol Myers Squibb for reviewing the article and providing valuable suggestions in shaping this article.

Good Documentation Practices (GDP)

According to federal regulations ( 45 CFR 46 ), by definition, research is ‘a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge’. The ability to meet that aim depends on multiple factors, one of which is the ability to collect ‘good’ data (meaning, the data is accurate, reliable and reproducible).

In order end up with a ‘good’ dataset at the end of a project, study teams must be cognizant of maintaining accurate records/documentation throughout the entire course of the research.

GDP definition

Good Documentation Practices (GDP) is a term used by the pharmaceutical, laboratory and manufacturing industries to describe best practices surrounding the creation and maintenance of documentation (in both paper and electronic format).

While there is not one specific regulation or policy that defines GDP, components of GDP are cited by federal and international agencies, including the Food & Drug Administration (FDA), the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), and the World Health Organization (WHO), as well as institutional policy.

GDP is essentially good recordkeeping practices to help ensure the quality and integrity of the data collected . This is applicable to all types of research, both biomedical and social/behavioral/educational, and includes records and documentation of study observations, activities and data.

Key attributes of ‘good’ documentation

Key attributes of ‘good’ documentation, often referred to as the ALCOAC standard, and include documentation that is:

Study documentation should identify who recorded the data/information; the information should be traceable to a person, date and time (as appropriate).

Study documentation, including signatures, should be easy to read, understandable, and identifiable.

Information should be recorded as it happens and the information recorded within study documentation should flow in a correct and appropriate timeframe.

Study documentation should be the original source document. Alternately, an exact/certified copy of the original (as appropriate) should be maintained, with notation referencing the original source.

Study documentation should be correct, free from errors, consistent and a real representation of facts.

Study documentation should be all-inclusive and comprehensive.

More attributes

Additional key GDP attributes include:

  • Corroborated

Putting GDP into practice

To put the key attributes described above into practice, consider the following GDPs:

  • When developing data collection forms, add initial/signature and date lines to indicate who recorded the data.
  • Only use wet ink (blue or black pen) on paper documentation to ensure permanency; do not use pencil, crayon, or marker. Do not use signature stamps in lieu of a handwritten signature, for example on a consent form or signature log.
  • Write dates, minimally, with the first 3 letters of the month instead of a numerical representation of the month to accurately/clearly document the date. This is particularly important for multi-site and international trials as local customs vary (7/12 in the US is July 12 th while in Europe it’s December 7 th ).  Best practice is to use a day-month-year format (i.e. 11APR2022 or 11APR22). Similarly, time should be recorded using a 24-hour clock or military time (i.e. 17:00 as opposed to 5:00pm). Use consistent date and time formats throughout all documentation to decrease confusion.
  • Do not pre- or back-fill dates, time, data, initials or signatures; never sign anyone else’s name on study documentation. Data (including signatures and dates) should be recorded in real time, by the originator.
  • Ensure units of measure are identified, as appropriate.
  • When errors are made, an audit trail of edits should be maintained. The change should not obscure the original entry; do not white-out, cross out or otherwise redact the original entry.  Draw a single line through the error, note the correction, including a reason for the revision (as appropriate) and sign and date the correction.
  • Ensure all missing data points are noted and explained in the study documentation (e.g., was the procedure missed inadvertently, skipped on account of time constraints or refused by the subject).
  • Conduct independent quality checks (i.e., second person verification) on critical or pivotal entries, minimally, to ensure ALCOAC standards are met.

Related resources

Source documents and source data, study documentation faqs, study documentation requirements, study site file contents description, recorded training sessions.

Archived UR-HRPP Educational Forums are available. To access recordings listed below, follow our Blackboard Self-Enrollment Instructions and enroll in the course titled ‘UR-HRPP Educational Materials’:

  • 12/9/2021: Essential Study Documentation – Part 1
  • 1/21/2022: Essential Study Documentation – Part 2

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Let The Document Tell The Story: Document Management Best Practices

Let The Document Tell The Story Document Management Best Practices

Good stories follow a 3-act structure:

  • Act 1: Set up
  • Act 2: Conflict
  • Act 3: Resolution

“Thanks a lot, Aristotle, but we’re interested in documentation, not story-telling.”

Except your documents are the story of your company and your company's device. 

Let me explain. 

For every document within your Quality Management System, there is an expectation of some level of “traceability.” 

What is traceability? Traceability is the process of leaving breadcrumbs—both upstream and downstream. For example, if your assembly process generates a record, you should be able to look at that record and determine its history. What Work Instruction was used? What Form was used to create that Work Instruction? What Procedure governed that Form? 

It’s up to your organization to define the extent of traceability needed to meet all applicable regulatory requirements, but every document must be traceable at some level. And it’s that requirement for traceability that creates the overarching story of your company and your device. 

Here’s how it happens:

FREE DOWNLOAD: Click here to download a free resource on how your company can benefit from a formal document management solution.

Act 1: The Set Up

Section 4.2 of ISO 13485 - Quality Management System for Medical Devices is titled “Documentation Requirements.”

For medical devices, best practices for Document Management start in Section 4.2 of ISO 13485 - Quality Management System for Medical Devices. This section of the standard is titled “Documentation Requirements,” and it gives you a roadmap—a starting point. “The quality management system documentation shall include…” and then it gives you a list!

Now, let’s talk about one of the specific documents mentioned in ISO 13485 Section 4.2: the Quality Manual.

When you create your Quality Manual, you’re expected to lay out the scope of your Quality Management System, any documented procedures needed for the QMS, and a description of the interaction between those processes. 

This is the Set Up.

The way a lot of companies do this is by listing out, or referencing, every Standard Operating Procedure (SOP) governed by the Quality Manual. Because you’ll want to show how you’ve met ISO 13485 requirements, there is often a table at the end of the document showing how each section relates to the requirements in ISO 13485. 

Sweet, you now have a document that clearly lists your procedures internally, and shows how you meet requirements externally. In the next layer down—the Standard Operating Procedures—you’ll likely have references to each SOP’s specific Forms and Work Instructions.

When this is first set up, it’s a beautiful thing; it’s almost a 3D history of everything your company plans to do, from a quality standpoint. 

You’ll learn to love traceability.

Act 2: The Conflict

Eventually, something will need to change, and that change precipitates the Conflict between old and new versions of a document.

When it comes to best practices, the first and greatest commandment is to have a single source of truth. You have to set up your document management system in such a way that released documents are easily distinguishable from obsolete or superseded documents

When you have documents stored in DropBox, SharePoint, Google Drive, your desktop, the file cabinet, the shop floor, and your email, at some point you will forget what the latest version or revision number is, unless you have a single source of truth, and you go to that source every time (please, don’t let it be your desktop.) 

Pro tip: ditch the extra storage and use the single source of truth to pull the right version of the published document every time. 

The second command is similar to the first—don’t duplicate information across documents. 

Think about it. If and when those changes come up, you don’t want to have to scour your entire QMS to find all the other places this changing information is written. Best practice: reference, don’t duplicate.

Act 3: The Resolution

Once you’ve made all the changes to your documents, it’s important to do two things:

Publish with due diligence - make sure the appropriate parties understand, approve of, and sign off on the change. 

Supersede and/or Obsolete all instances of the previous revision/version of the new document.

And that takes us to the Resolution. Because if you’ve used a single source of truth, published with due diligence, and superseded all previous documents, there shouldn’t be any conflict left in your documentation. In fact, you should have a beautiful story to tell with great satisfaction during your next audit or inspection.

Tips for writing your story

Finally, let’s talk about the best way to write your story. In the medical device industry, we call this Good Documentation Practice, or GDP.

Everyone gets tripped up by GDP at some point. There are some do’s and don'ts that every medical device professional should know.

Good Documentation Practice Do’s:

Record the entries, whatever the activity is, in real time.

Always include a date next to your signature (and follow the date format in your procedure! Is “2/10/22” February 10th or October 2nd??) 

Good Documentation Practice Don’ts:

Don’t use whiteout! Cross out mistakes with a single line so it is still legible. 

Never backdate. If something is signed after the fact, use the current date and provide an explanation.

Greenlight Guru helps you tell your medical device’s story right the first time

When it comes time to tell the story of your device, you want to be sure it’s clear, concise, and above all, accurate. 

With Document Management software from Greenlight Guru, you’ll never find yourself chasing down stakeholders or searching frantically for documents. Our QMS Software  allows you to see your document structure in a centralized view and offers complete version history, e-signatures, and watermarks that automatically highlight a document’s status—so you know for sure everyone is working on the most recent version.

Ready to tell an amazing story about your medical device? Then get your free demo of Greenlight Guru today!

Looking for a design control solution to help you bring safer medical devices to market faster with less risk? Click here to take a quick tour of Greenlight Guru's Medical Device QMS software

Etienne Nichols

Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project...

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Good Clinical Practice Study Documentation

The Department of Medicine Clinical Research Unit has prepared this document is to provide guidance to all faculty and staff involved in the conduct of research on the  best practices related to documentation .

Good study documentation will allow for an individual with basic knowledge of the particular project to recreate the events of the study.

General Information

  • Maintain records of all data and observations pertinent to the research subject.  These records should be identifiable to a particular participant.
  • Remember that source documents are where the information is first recorded.
  • All data must be verifiable.
  • Study documentation should be able to recreate the study for any reviewer.
  • Attributable – Can you tell who wrote and/or did this
  • Legible – Can it be read?
  • Contemporaneous- – Is the data current, and in the correct time frame?  The notation, signature and date should occur at the same time.
  • Original – Has the data been altered?
  • Accurate – Are there conflicting data elsewhere?  Content should precisely reflect the event.
  • Use a signed Note to File to explain any discrepancies, missing or incomplete data.
  • The same standards maintained for medical documentation should be followed for research documentation
  • All documents require 2 identifiers on each page. 
  • All entries are to be signed and dated in real time.
  • Error corrections are made by drawing a single line through the incorrect entry, initial and date.
  • Never obliterate entries that require correction.
  • Subject records need to be secure but accessible.
  • Do not alter past-dated notes by writing alongside or adding to prior entries.  Updates may be made through addenda.
  • Use dark ink, do not use pencil.
  • Never use whiteout.
  • If the source data is incomplete or deficient, it may be completed or corrected using an addendum.  This late entry must be signed and dated at the time it is created.

Note to File

  • May be used to correct errors, or as an explanation to a departure from the protocol.  Reasons for any departure should be documented and attempts to correct or prevent in the future should be included.
  • This should not be used as a panacea to correct any error.

Informed Consent

  • The process requires documentation and should reflect the process approved by the IRB in a narrative form or through the use of a checklist.
  • Signature and date and time must be of the person obtaining the consent, at the time of the process. (Not added later)

Case Report Forms as Source

Case report forms may be used as source only when this practice is clearly outlined in the protocol, and they represent the data collected for the research are where the data were initially recorded.   

Medical Records From Outside Source

  • Copies of records from an outside source may be used if they support endpoints, inclusion/exclusion criteria or adverse events.
  • Attempts to obtain medical records should be recorded in the research chart.

Questionnaires

  • Documentation must reflect who completed the questionnaire, in compliance with the protocol.
  • For questionnaires completed by staff, a note should reflect how the information was obtained ie: direct interview with participant, phone call, chart abstraction.
  • Reference Manager
  • Simple TEXT file

People also looked at

Original research article, patient safety through nursing documentation: barriers identified by healthcare professionals and students.

www.frontiersin.org

  • 1 Faculty of Nursing and Health Sciences, Nord University, Levanger, Norway
  • 2 Centre for Care Research Mid-Norway, Levanger, Norway
  • 3 Faculty of Nursing and Health Sciences, Nord University, Namsos, Norway
  • 4 Centre for Development of Institutional and Home Care Services, Municipality of Aafjord, Norway

Background: Although access to accurate patient documentation is recognized as a prerequisite for delivering of safe and continuous municipal elderly care, healthcare professionals often fail to provide comprehensive clinical information in an accurate and timely manner. The aim of this study was to understand the perceptions of healthcare professionals and healthcare students regarding existing barriers to patient safety through the performance of documentation practices.

Methods: Using a qualitative, exploratory design, this study conducted six focus group interviews with nurses and social educators ( n = 12) involved in primary care practice and nursing and social educator bachelor’s degree students from a University College ( n = 11). Data were analyzed using qualitative content analysis.

Results: Four themes emerged from the analysis, which described barriers to patient safety and quality in documentation practices: “Individual factors,” “Social factors,” “Organizational factors,” and “Technological factors.” Each theme also included several sub-themes.

Conclusion: According to the findings, several barriers negatively influenced documentation practices and information exchange, which may place primary care patients in a vulnerable and exposed situation. To achieve successful documentation, increased awareness and efforts by the individual professional are necessary. However, primary care services must facilitate the achievement of these goals by providing adequate resources, clear mission statements, and understandable policies.

Introduction

High-quality patient documentation in primary care is crucial for ensuring the quality of care, continuity of care, and patient safety. For many years, the quality of nursing documentation has been reported as inadequate ( Hellesø and Ruland, 2001 ; Blair and Smith, 2012 ; Akhu-Zaheya et al., 2018 ). Thus, knowledge about primary care staff perceptions of barriers to documenting in electronic health records is necessary to ensure patient safety in the services.

The elderly population is expected to grow in both European and American countries in the near future, which will be accompanied by increased demand for elderly healthcare services. This growing patient population will require both complex medical treatment and nursing care ( Ministry of Health and Care Services, 2012 ; Kulik et al., 2014 ). To ensure the effective use of healthcare resources and improve patient outcomes, many Western countries are attempting to transfer responsibilities from specialist care to primary care. This change has resulted in patients who are treated in municipalities being frailer and presenting with more advanced, complex, and treatment-demanding issues ( Gautun and Syse, 2017 ; Næss et al., 2017 ). In Norway, we have enacted “the Coordination reform” ( Ministry of Health and Care Services, 2009 ), a collaborative model for the provision of care services between hospital care and primary care, which is similar to the international concept of “integrated care” ( Ahgren, 2014 ; Ferrer and Goodwin, 2014 ). The implementation of such increased and formalized coordination strategies represents a political focus as a potential tool for ensuring the efficacy and safety of elderly care.

This increased complexity in primary care nursing requires awareness and a focus on providing appropriate nursing-supportive tools, such as high-quality electronic patient records (EPRs) as a main tool for nursing documentation practices. The provision of sufficient documentation of healthcare associated with the patients’ physical and mental health issues is particularly important among elderly patients because even minor changes in health status could be symptoms of severe or acute illnesses ( Gray et al., 2002 ; Chong and Street, 2008 ; Cerejeira and Mukaetova-Ladinska, 2011 ). Any lapse in mental or physical health requires specific medical, nursing, and caring actions to be taken ( Marengoni et al., 2011 ).

The implementation of EPR as a tool for documenting healthcare has resulted in major changes and increased requirements for nursing documentation ( Ammenwerth et al., 2003 ). EPR implementation was intended to replace handwritten documentation practice and improve documentation structures to promote increased standardization ( Hellesø and Ruland, 2001 ). In Norway, nursing homes and community care document care electronically use one of only three EPR systems ( The Norwegian Directorate of eHealth, 2018 ). The EPR documentation practice consists typically of income notes, patient mapping, nursing actions, daily notes and -evaluation as well as discharge notes. E-messaging modules, medication, and collaboration with other professionals such as doctors and physiotherapists are included and used as well. In any case, to complete the documentation requirements, there seems to be a need for paper-based supportive systems, which tend to involve checklists, calendars, books, and post-it notes ( Keenan et al., 2013 ). Nursing procedures and other supportive systems, such as tools for reporting adverse events, are either included in the chosen EPR system or solved in external systems. This study addresses this broad documentation practice.

Both legislation and practice for nursing documentation in healthcare services vary among countries; however, primary care nurses occupy a unique position within healthcare structures worldwide. Primary care nurses often work with few other nurses in primary care wards, or they meet patients alone at the patients’ homes. Therefore, they are often required to assess and evaluate patients, acting independently of other colleagues. Home-health nurses might not have access to online EPRs, which would allow for them to consult previous nursing interventions and evaluations, and they must perform their own documentation, which they may be unable to do until they return to the home care center office ( Olsen et al., 2013 ).

Even though EPR was implemented over a decade ago and is widely used in primary care in Norwegian municipalities, healthcare services continue to face documentation challenges that result in adverse events. Studies have shown that primary care employees often struggle to coordinate patient information in the EPRs ( Gehring et al., 2012 ; Melby et al., 2018 ), and primary healthcare documentation continues to be both incomplete and inaccurate ( Tuinman et al., 2017 ; Moldskred et al., 2020 ).

Patient safety and EPR documentation tasks are closely connected. Documentation in EPR is important to ensure continuity, quality, and safety of patient care. EPRs represent a communicative and collaborative tool, in addition to serving as the written record for which actions have been implemented.

Various definitions of patient safety have emerged over time ( Mitchell, 2008 ), including:

Patient safety is a discipline in the health care sector that applies safety science methods toward the goal of achieving a trustworthy system of health care delivery. Patient safety is also an attribute of health care systems; it minimizes the incidence and impact of, and maximizes recovery from, adverse events ( Emanuel et al., 2008 , p. 16).

The World Health Organization (WHO) vision for patient safety is “A world where every patient receives safe healthcare, without risks and harm, every time, everywhere” ( WHO, 2017 , p. 4). In this vision, it is stated that, until recently, patient safety research has primarily focused on the hospital setting rather than primary care. The WHO strategy “Safer primary care” focuses on nine improvement areas: patient engagement, education and training, human factors, administrative errors, diagnostic errors, medication errors, multimorbidity, transitions of care, and electronic tools ( WHO, 2012 ). These focus areas are all relevant to the context of patient safety and documentation.

Elderly patients often suffer from comorbidities, which require complex and tight regimes of treatment and care ( Marengoni et al., 2011 ). Meeting this demand requires high-quality nursing homes and ambulant healthcare services capable of working among elderly patients outside of hospital settings. The coordination of treatment and care, documentation, and patient information exchange represent particular challenges, and these areas have been characterized as being of particular risk for adverse events ( Olsen et al., 2012 ; Blais et al., 2013 ; Olsen et al., 2013 ; Gjevjon 2014 ; Wekre, 2014 ).

Patient safety can be evaluated by mapping adverse events that occur in healthcare units. Studies have shown that 1–24 adverse incidents occur during every 100 consultations in the primary care context ( Panesar et al., 2015 ). A link between patient safety and inadequate documentation has previously been reported by studies examining documentation and adverse events in primary care. For example, Andersson et al. (2018) examined serious adverse events reports submitted by nurses in Swedish nursing homes to the Health and Social Care Inspectorate and found that a “lack of competence” and “incomplete or lack of documentation” were the two most common factors that contributed to adverse events.

This study has identified few articles focusing on the connection between patient safety and nursing documentation practices at home health nursing services or nursing homes. Additionally, there is a need observed for additional research projects that focus on students’ experiences regarding the practice of patient documentation and the use of EPRs.

Social educators are employed in municipal care: in nursing homes and home healthcare units in Norway. They take part in a variety of nursing and caring tasks and activities, but their profession has more substantial knowledge in caring for people with various forms of disability than Registered Nurses. They have a deeper focus on rehabilitation and habilitation for disabled patients. On the other hand, Registered Nurses have a deeper awareness of the medical issues of nursing, as understanding of all kind of illness and its consequences, as well as medical treatment and medication ( Grung, 2016 ). Nevertheless, when social educators are employed within the healthcare domain in Norway they are obligated to act under the same legislation guidelines regarding documentation as Registered Nurses. Understanding the experiences and perceptions of these staff members can also influence their contributions to collaboration in healthcare services. Therefore, the aim of this study was to better understand the perceptions of healthcare professionals and healthcare students regarding existing barriers to patient safety through the performance of documentation practices.

A descriptive, exploratory design ( Polit and Beck, 2012 ) with a focus group methodology was applied to provide insights into the perceptions of nurses, social educators, and students and to understand their experiences in terms of patient safety and their documentation practices. To secure accurate and complete reporting of the study, the COREQ checklist ( Tong et al., 2007 ) was used as a guideline.

Sample and Setting

The study was conducted between March 2015 and June 2015 at three3 primary care agencies and one University College located in central Norway. In the chosen region, all municipalities use the same EPR system—one of three main systems used in primary care in Norway—and similar to all other systems being used this one responds to the legislation requirements for digital documentation of healthcare information in Norway as well as GDPR regulations which Norway joined in 2018 ( Ministry of Health and Care Services, 2012 ; The Norweigian Directorate of eHealth, 2019 ). This particular EPR solution, as is the case for the other two EPR systems, offers an enlarged EPR solution where the EPR module is connected to other relevant modules; for example, basic personal information, billing, and medication order modules.

Purposive sampling was used to recruit participants. The inclusion criteria for the nurses and social educators included that they were employed in primary healthcare (nursing homes or home nursing care) and that they were involved in direct patient care. The inclusion criteria for students included regular enrollment as a nursing or social educator student (at the bachelor-degree level) and previous practice in nursing homes and/or in-home healthcare settings as part of their education. Whereas the professionals were recruited by their ward managers, the students were recruited by contact persons at the University College. Both professionals and students were forwarded written information about the study, and all signed a consent form prior to participating in the study.

In total, 12 nurses and social educators and 11 students (22 women and one man) volunteered for this study. The mean working experience among the nurses and social educators was 13°years (ranging from 1 to 25 years), and their mean age was 40.5°years (ranging from 23 to 51°years). The students’ mean age was 23°years (ranging from 22 to 28°years). six of the students were in their final semester of a 3 years degree program, and five were in their penultimate year. The participants were interviewed in six focus groups; three groups of nurses and social educators (“staff informants”) and three groups of students. The sizes of the groups ranged from 3–5 participants, which is considered an optimal size for focus groups ( Kitzinger 1995 ).

Data Collection

Focus group interviews were used to study perceptions among the group participants ( Polit and Beck, 2012 ). In the focus groups, the participants were invited to reflect upon and compare each other’s views and experiences to contribute to a broader understanding of patient safety and documentation practices ( Kitzinger, 1995 ).

The study applied an interview guide, which was developed based on performing a literature search and including previous clinical experiences and knowledge among the researchers. The interview guide included these areas:

Descriptions of patient information exchanges, collaborative procedures, and documentation practices applied during patient transfer.

Descriptions of daily nursing and care planning, communications, and documentation processes.

Uncovering whether EPR solutions meet professional needs with regard to patient information.

Descriptions of communications or EPR documentations that have caused or could cause adverse events.

As described by Krueger and Casey (2009) , the focus group interviews were performed by two researchers: a moderator and an assistant. The moderator guided the discussion while the assistant kept track of the tape recording, made notes, and summarized the discussion. The focus group interviews lasted from 90 to 120 min, and all audio was recorded and transcribed verbatim.

Data Analysis

Data were analyzed using qualitative content analysis ( Krippendorff, 2018 ). The authors listened to each recorded interview and simultaneously read the transcribed text to obtain an overall view of the data. The texts were re-read several times to allow reflection on barriers to patient safety through the documentation practices for healthcare professionals and healthcare students. Then, the text was broken down into meaning units (i.e., words, phrases and sentences that relate to the same central meaning), which were condensed and labeled with a code. Based on similarities and differences, the codes were compared and sorted into nine sub-themes and four main themes. All authors participated in the data analysis and jointly discussed possible approaches to each theme until a consensus was reached ( Patton, 2012 ).

By following Lincoln and Guba (1985) criteria, several strategies were used to enhance the trustworthiness of the study. Credibility was supported by including an adequate number of professional and student informants, encouraging dialogue in the focus group sessions, and by discussing the interpretation of data until a consensus on themes and sub-themes was reached. Providing descriptions of informants, data collection, analysis, and quotes from the focus group interviews enabled each individual reader to assess the transferability of the study findings to other contexts. Dependability and confirmability were achieved by using audio-recording during the interviews and transcribing all interviews verbatim and by having all authors discussing the data interpretations together.

Ethical Considerations

The study was implemented in accordance with the Declaration of Helsinki ( World Medical Association, 2001 ). Formal permission to perform data collection was obtained from the authorities at all municipalities and the University College. All nurses, social educators, and students were written-informed of the study and provided informed consent to participate. They were made aware of their rights to withdraw from the study at any time without consequence. The project was conferred with the Norwegian Center for Research Data (NSD), which concluded it not being notifiable.

The focus group analysis resulted in the identification of four main themes to describe the perceptions held by healthcare professionals and healthcare students regarding existing barriers to patient safety through the performance of documentation practices in primary care: 1) Technological barriers, 2) Organizational barriers, 3) Social barriers, and 4) Individual barriers. As shown in Table 1 , each of these themes included several sub-themes. All participants responded based on experiences using the same EPR system to perform documentation tasks. In the presentation of results, the municipal nurses and social educators are described as a single group, referred to as “staff” or “nurse”. Quotes from the focus group sessions are used to elucidate the themes and sub-themes.

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TABLE 1 . Themes and sub-themes describing barriers for patient documentation.

Technological Barriers

This theme included three sub-themes and refers to the technological obstacles that the nursing staff and students were required to overcome when documenting patient care. The informants of this study described unstable system access as one of the main technological challenges. All participants described experiencing time-consuming log-in procedures, lasting more than 5 min each time, and not particularly connected to the EPR system itself but to the municipal server setup system requiring several levels of log-on procedures. Encountering this barrier would result in participants leaving the computer without logging off as expected, or they would ask a colleague to perform documentation on their behalf to avoid using their time for waiting for system access. They admitted that both practices were against security rules. Another example was unannounced system downtime caused by random and unforeseen internet issues, which could occur in the middle of documentation or while using the EPR system for shift reports or doctor’s visits. These experiences prevented the informants from using the system completely. Nursing staff and students had described experiencing the loss of system access due to planned, unannounced technical maintenance. These episodes resulted in a lack of trust in the EPR system, and respondents reported the regular use of paper-based backups for the most important patient information, such as patient personalia, patient contacts, and medication lists.

Further, the respondents presented the EPR system as incomplete, with deficient system usability and user interface that did not support their needs and requirements for daily nursing documentation routines, resulting in the use of a paper-based documentation system as a supplement to secure documentation, information exchange, and patient safety. One example was a staff informant group who still used the previous manual documentation system as a back-up:

When we need to find information about a patient, we must first go to the EPR system to see if we can find it there. If it is not there, we must look in the ‘Kardex’. It can take some time, then, if you are unsure where to find it.

Deficient system usability and user interface were found to be risk factors for adverse events. Multiple areas could be used to document the same information within the EPR system, which made documentation fragmented and difficult to rediscover when the nursing staff required the information. The EPR system did not follow the logical nursing planning structure that the informants expected and were trained for, which also increased the potential for adverse events. One staff informant stated:

…and it is a bit scary in everyday life because we are actually responsible for what we do, and when the system is designed so that you are tricked into making mistakes, as we do our job.

Usability and interface problems also included small fonts and compressed text that made information difficult to read and was another possible risk for adverse events.

The final technological barrier was the lack of technical support . When informants experienced problems, such as the system being down or log-on problems, these issues could only be addressed during a normal working day between 08:00–16:00, with no support offered during night shifts, weekends, or holidays. This lack of support was another reason many of the staff informants relied on paper-based backups and handwritten notes that would later be added to the EPR system. Paper-based backup routines were viewed as a necessary workaround; however, all participants admitted that paper backups were a safety risk because documentation became fragmented and paper notes could be lost.

Organizational Barriers

This theme includes two sub-themes and refers to barriers within the organizational system, which made informants struggle when documenting patient information. Even though the informants of this study had experience using the same EPR system, each municipality was able to some extent to technically adjust the system setup according to their existing or desired organizational routines. This ability resulted in some variety in documentation routines. Thus, informants reported both shared and unique organizational documentation challenges and barriers between the focus groups.

Many of the organizational barriers were ascribed to inappropriate documentation routines in the unit. The EPR system was implemented many years ago, and it included areas suitable for registrations. However, some units maintained old routines, using notes, lists, and notebooks to document care. Some focus groups reported the reduced use of paper-based documentation, even though some paper-based routines were maintained due to technical issues, as described above. Other routines were maintained despite an awareness of the possibility of causing adverse events. The complete and expected reorganization of documentation routines was simply never initiated after implementing the EPR. In one of the student groups having experiences from a variety of municipalities, this frustration was shared:

A big source of error is that you always have to remember where to look for things; where to check the patch, the medications, where to find time appointments, and there, and there, and there and in addition you have to take care of the patients and keep them in mind, and then you have to keep in mind if there is any wound procedure, and then you have to keep in mind inhalation and the eye drop form in the closet, and. -You have to constantly go and keep in mind!

This inappropriate routine was confirmed by the student informant groups, who faced even more substantial challenges when attempting to retrieve information from multiple sources.

Furthermore, this theme also addressed a severe barrier to patient safety: inappropriate routines that included a lack of patient information. A lack of patient information either caused adverse events, or these adverse events were avoided by the clinical skills of the nursing staff or, as described by study informants, pure luck. Nursing staff had experienced rigid organizational EPR routines, in which only a few persons were permitted to add or change basic patient information. One example provided was an acute situation in which no family information could be found. The nurse involved traced the phone number of the patient’s daughter on the internet because she knew her name, but this informant said, ‘ It was a bit hectic to find the daughters phone number, and simultaneously trying to save the patient`s life while waiting for the ambulance to come ’. Lack of such information could lead to phone calls to the wrong individuals and a breach of confidentiality.

Staff informants had experienced not being allowed to add medical diagnoses to the EPR system because this task was reserved for the patient’s doctor. However, if the doctor did not perform this task diligently, the nurses had to guess which underlying illness the patient suffered to complete their nursing observations and actions. Lacking blood sample results was a recurring problem that was reported by multiple groups of informants. These results did exist, but sample information was not found. Partly, the results were not sent as e-messages and thereby not found within the EPR system as expected, or results were not inserted into the EPR system when received through a letter or phone call. Much time and effort were spent tracking answers to determine the correct administration of medications, potentially causing harm to the patients. In a staff focus group, one informant told:

Yes, we can wait for several days for answers for blood samples (…), and quite a few nurses get frustrated. We take a test on Monday and do not receive a response from the doctor before Thursday. So, then you should be happy that the nurse knows the users and give them what they think is right. It’s a big problem in the rural areas. It takes time.

One result of the different documentation practices in the various units was a fragmented documentation structure , which led to confusing patient information . This barrier was viewed as an organizational reinforcement of the technological barrier due to the organization allowing so much confusion in the structure of the EPR system. In the focus group sessions, the informants discussed the lack of overview of patient information in their documentation practice. In all of the focus group meetings, the informants discussed the time spent searching for patient information within the fragmented patient information structure. “ There is a lot of paper lying all around.”

Both within the EPR system and between the EPR system and the paper-based supplementation systems, time was spent searching for, checking, and double-checking information. Both students and nursing staff experienced the documentation structure as a risk for patient safety. Furthermore, variations were found in the structure of care planning within the EPR system. Our informants reported the availability of both firm templates for documenting nursing actions and evaluations in addition to day-to-day reporting practices. Day-to-day reporting did not provide a broad overview and represented a risk of losing important follow-up areas for each patient. In contrast, a care-planning template with too much detail could overly fragment patient information and increase the risk of adverse events.

Another identified risk area was patient transfer reports. Our groups discussed the lack of a transfer documenting template and the various shapes of the reports. The following quote from one staff informant was representative for concerns expressed among all groups interviewed:

It is not specified what to write in the transfer report, so it is left to each person to decide and what she emphasizes of observations.

Poor reports increased the risks for adverse events, which could often only be prevented by making phone calls to verify the necessary information required for medical treatments and nursing follow-up.

Social Barriers

This theme included two sub-themes associated with barriers to patient documentation that were not recognized as being caused by the organizational structures of the units. The main social barrier associated with an increased risk of adverse events was that documentation had lower priority compared with other tasks in the caring unit. Practical, daily tasks and patient-oriented work had higher priority and were more accepted among the nursing staff than spending time on the computer. During hectic shifts, our informants would rather relieve their colleagues than update the EPR. Thus, documentation tasks were postponed. This finding was confirmed by some student informants, who had received negative feedback if they spent too much time reading or updating the EPR instead of participating in direct patient-related activities. Our informants provided multiple examples in which they did not spend time learning how to use the EPR system or did not know where to document their nursing actions, and they described the dilemma. One staff informant said:

It is the issue of closeness to the patient. It is central in our caring to spend time with the patient. Documentation becomes a secondary issue, which I feel have to get into the heads of nurses: they must understand the importance of documentation! Why should you read? To stay updated.

A reoccurring issue that appeared in the focus group discussions was obvious avoidance regarding documentation practices in some units. The study found unequal attitudes towards the documentation of adverse events, even if the informants all agreed that the public strategy in their working units was to welcome such registration. However, the social attitude was that documenting an adverse event could be viewed as a form of self-punishment rather than as an opportunity for common learning and improvement. One of the focus groups consisting of staff participants discussed their proactive system developed to report and address adverse events, which was accepted and followed by staff members. The unit maintained a quality system known to everyone, and deviations from procedures were marked and reported as an adverse event and was followed up by leaders, as the procedure required. But even here:

We have had many plenary discussions now about the positivity of documenting deviations (…), but we think there is a lot below the surface that is not registered and reported.

This response revealed a developing culture for the handling of adverse events, which continued to face cultural challenges. The staff informants discussed their experiences with social change, moving towards a more pro-active attitude regarding the documentation and learning from the mistakes that led to adverse event registrations.

Individual Barriers

This theme includes two sub-themes and refers to the barriers associated with personal characteristics that may influence a staff member’s documentation practices. The barrier lack of motivation to comply with routines and policies was neither a result of the organizational regime nor a social structure within the units. When documenting nursing actions, the units had routines and procedures designating where in the EPR system nursing assessments and measures should be documented, but these guidelines were not always followed. Some staff informants admitted that they did not want to use the available tablet personal computer (PC) to document the EPR.

We act so different. Some of us document and take it very seriously. Document everything (…) everything done in a day, while others are better at documenting what is relevant for the patient care (…) And some do not write at all.

The staff informants stated that they and their colleagues did not always read the EPR when they began their shifts or did not thoroughly examine the documentation, such as when administering medications. Important information could be missed, leading to adverse events of varying degrees of severity. Time shortage or not sharing the same sense of responsibility for documentation were the explanations given for not accomplishing documentation tasks, either in a standardized way or at all. However, not having complete and sufficient patient information is a risk factor for adverse events and was also a stress factor for our informants in their daily work.

Our focus group informants discussed their common experiences of inadequacy, insecurity, and lack of knowledge regarding the ability to document patient information properly. In particular, staff informants experienced a lack of confidence, skills, and knowledge necessary for documentation tasks, even if they had have received both an education and formal training on the topic.

It’s easier not to do it, when you are insecure, than to do it. It is about they don’t exactly know how to do it … and then they do not; not document at all, leaving it to someone who can. And then there are a few who are very good at it, and the days they are not here, then it will not be done.

Basic information and communications technology (ICT) skills varied among the participants and strengthened the sense of insecurity described above. Our student groups did not address such insecurity in the same manner as our staff informants did. The challenge included where to search for or document patient care.

It feels safer to document it all under “general information” because you have not analyzed so much yourself then, on your own.

They reported low confidence in their own and their colleagues’ ability to place documentation elements correctly in the EPR system, resulting in a fundamental concern regarding the quality of patient documentation and a constant fear that adverse events will occur. To overcome these barriers, they searched for, checked, and double-checked available patient information sources within and outside the EPR system to secure the quality of care. They had to rely on oral handover for adequate patient information.

You must ask the nurses you work with; maybe they know, but it is not certain you get the right answer.

Individual use of phrases in documentation practice was also discussed in the focus groups. The student groups, in particular, felt unsafe when nurses used phrases and words not familiar to them; however, staff informants also expressed problems with individual approaches toward documenting language, subsequently making it difficult to contextualize follow-up activities.

Our informants worried about their ability to remember all messages and tasks and their ability to accomplish their documenting duties correctly, particularly during busy periods. The documentation of drug administration was a major challenge reported for individual documentation practices among our informants. Most adverse event reports were associated with the area of medication. One student representative had the following experience:

One of our patients had anti-constipation treatment without being constipated: His elimination status was just not recorded anywhere.

Another example was not being aware of a missing blood sampling that was necessary to perform medication adjustments, resulting in incorrect medication; this error was recognized as a potential patient safety risk.

Uncertainty among the nursing staff was observed by the student groups, making them insecure during their practical study periods. Students also experienced expectations among the nurse staff, who expected them to know without being taught:

It is not documented anywhere! (…) and then they just said that I will learn this as I am working here more permanently.

This expectation of tacit knowledge frustrated them and made them anxious about potentially harming the patients due to a lack of patient information.

This study aimed to better understand the perceptions of healthcare professionals and healthcare students regarding the barriers to patient safety through the performance of documentation practices. The results demonstrated that technological, organizational, social, and individual barriers to nursing documentation pose potential risks to patient safety. Our results could be associated with seven of the nine areas outlined in the WHO strategy “Safer primary care” (2012). Follow-up thematic reports ( WHO, 2016 ) underpin the study’s results by many converging elements that involve safety risks.

Technological barriers were a basic challenge reported by our participants. Unstable system access, deficient EPR usability, and poor user interfaces, together with scarce technical support, did not support their nursing practice needs. The respondents struggled to document and access sufficient information to perform daily care. Similar findings were reported in Priestman et al. (2018) and in a review by Stevenson et al. (2010) and followed up by a study in 2012 where nurses reported that the EPR does not support their nursing practice ( Stevenson and Nilsson, 2012 ). WHO (2016) also emphasized the increased use of technical devices in primary care to improve patient safety. The report admitted that poorly designed EPR systems might create more work and frustration among staff, similar to our findings. A literature review by Gesulga et al. (2017) also recognized barriers, such as user resistance arising from data security concerns. Technological tools, such as EPRs aim for but do not necessarily achieve the prevention of human errors and the improvement of information exchange. Such tools can also create additional human work or new ways of working. Thus, the nursing staff became dependent on technological usability and stability to provide nursing and care and secure patient safety ( Dekker, 2016 ).

One of this study’s four main themes was organizational barriers, also identified as a main patient safety area by WHO (2012) ; WHO (2016) . Barriers were identified in this study, such as incomplete or inaccurate documentation routines and fragmented documentation structures. Kutney-Lee et al. (2019) also found correlations between organizational issues, such as work environment, patient safety and EPR system usability. Many documentation errors by use of the EPR systems can be caused by deficiencies in the organizational structure in a care unit, such as patient transfers, something many participants also described in the study, including “poorly written or illegible discharge summaries” ( WHO, 2016 ). “Transitions of care” is also emphasized as a focus area by WHO (2016) as well as in other studies ( Graabæk et al., 2019 ; Patel and Landrigan, 2019 ). This topic identifies several risk areas related to patient safety that were also discussed by our informants: increased adverse events, delays in receiving appropriate treatment, and lost tests or blood sample results. Studies suggest interventions to prevent safety risks such as standardization of documentation and discharge information ( Törnvall and Jansson, 2017 ; De Groot et al., 2019 ), all of which were supported by our informants: for both transition situations and to improve the documentation structure in general.

Two sub-themes were regarded as social barriers to documentation in the EPR. The study found that spending time documenting had a lower priority than other tasks and that in some units, the staff groups showed avoidance behavior toward documenting practices. Similar negative attitudes toward documentation have been reported previously, such as in Bøgeskov and Grimshaw-Aagaard (2018) research, in which nurses in hospitals perceived documentation as being a meaningless burden that hindered them from focusing on the patient. When the safety culture within staff groups undermines documentation tasks, identifying whether the underlying reasons for these attitudes and behaviors are associated with the priority of direct patient care or whether other causalities exist is imperative ( Barkhordari-Sharifabad et al., 2017 ).

Individual barriers to documentation practices included both a lack of motivation for documenting practices and the informant’s sense of inadequacy, insecurity, and lack of knowledge regarding correct documentation procedures. Designing systems that better support the nursing staff can contribute to their motivation to comply with the established routines and policies for documenting tasks ( Stevenson et al., 2010 ). Improved system usability may reduce the occurrence of potential adverse events and increase patient safety ( Williams, 2019 ). One area associated with severe patient risk that was reported in our work was nursing staff not correctly updating or carefully reading the EPR when handling medication. WHO (2016) confirmed, in line with our results, “workload and time pressure” and “lack of accuracy in the patient record” as factors that increased the risk of patient safety harm. This is also found by other studies ( Al-Jumaili and Doucette 2018 ; Dunn Lopez et al., 2021 ). There appears to be a need for a more systematic approach to handling medication information, such as computerized decision support systems ( Marasinghe, 2015 ).

Reasons for not using the tablet PC for documentation were not provided in our result. However, tablets may reduce the time spent on documentation, as reported in the reviews by Dall’ora et al. (2020) and Blair and Smith (2012) . Lack of time was discussed by the healthcare staff as a reason for not documenting or postponing documentation tasks during their shift, as also noted by Söderberg et al. (2009) : therefore, it is necessary to cross this barrier to patient safety by providing an understanding of the use of the EPR as an efficient way of documentation time in contrast to time spent walking around, collecting necessary information among colleagues in the unit.

Lack of training, which was also emphasized by our informants, in our view, was regarded as an individual issue rather than an organizational problem. Our participants indicated inadequacy, insecurity, and lack of knowledge among their individual challenges but did not necessarily describe these issues as part of the organizational strategy because they had all received training sessions within their units. Bing-Jonsson et al. (2016) investigated the sufficiency of nursing staff competence in Norwegian community elderly care and found that documentation is one of the areas where nurses, auxiliary nurses, and assistants may have insufficient competence. The authors concluded that education and training alone appeared to have a limited impact on competence, potentially due to health professionals having unclear roles and inadequate standards for judging their own competence; they perform many of the same tasks, regardless of formal competence based on education ( Bing-Jonsson et al., 2016 ).

The student informants in our study described nursing staff who sometimes omitted the documentation of patient information and expected the students to know without being taught (i.e., tacit knowledge). Staff members in long-term elderly care often know their patients quite well and, therefore, may find documentation redundant because they maintain a lot of information “in their heads” ( Østensen et al., 2019 ).

Strengths and Limitations

One strength of this study is that the sample included a combination of healthcare professionals with considerable experience and bachelor-degree students with an outside view of the workplace. The students had experience from health services in several municipalities during their practical studies and contributed with useful reflections on similarities and differences between these areas in the focus group interviews. Only one man attended the study, which could be considered a limitation. However, this skewed gender distribution is reflective of the large proportion of women employed in elderly care.

The student informants were recruited from the University College where all authors were employed, but none of the authors were involved in assessing these participants’ academic elements of their studies. All students were made aware that participating in the research would have no impact on their progression through their bachelor’s program.

The use of a topic-based interview guide, instead of narrow questions, contributed to data-rich discussions in the focus groups. The authors experienced an open and trusting atmosphere during the sessions, where all informants shared honest reflections and described real challenges from practice. Lively discussions, both in the staff focus groups and the student focus groups, contributed to rich qualitative data. The years between data collection and publication may be seen as a limitation in the study, but we have also learned that changes due to digitalization in healthcare take many years to implement and adopt, as described by Morris et al. (2011) . Thus, we suggest that the experiences will still be relevant for healthcare organizations preparing for the implementation of ICT tools. The fact that the study involved one EPR solution may be regarded as a limitation. On the other hand, one may also consider this as a strength, because all informants reported on their experiences from a common starting point when describing their challenges. Involving municipalities with other EPR solutions could have expanded the picture of challenge. On the other hand it could have given responses based on more unequal prerequisites referring to various EPR systems. This could further have drawn attention away from challenges described in the result of this study, and more toward variations between EPR systems as such.

The fact that all 3 authors were involved in the analysis process was also an advantage. Due to the qualitative design, the results cannot be generalized. However, because the documentation of patient information is an important part of any healthcare professional’s practice, the study results could be transformed and applied to several other contexts in healthcare.

Conclusion and Implications

In this study, our results identified several barriers that negatively influenced patient documentation practices, exposing patients in primary care to increased safety risks and potentially harmful situations. To enhance and secure patient safety, increased individual, social, organizational, and technological support is necessary to overcome these barriers to ensure that optimal patient information is available when required for nursing care. To achieve this aim, primary care services must facilitate the necessary improvements by prioritizing technical, economic, and human resources for system development, training, and the definition of clear mission statements and policies.

The study results may inform various stakeholders in designing, implementing, using, and teaching EPR systems:

• System vendors may gain more knowledge of the complexity in nursing staff’s everyday lives, and to what extent implemented EPR systems still fail to meet the needs for documentation and information exchange continuing to risks of adverse events.

• Health service leaders and ICT leaders should pay close attention to system implementation and adoption phases paving the path for their staff members, not underestimating the complexity in documentation and information exchange in their caring units, all in order to secure and improve patient safety.

• Staff members and healthcare students may learn how colleagues and co-students experience their EPR documentation practice, reflecting upon their own situation regarding patient safety and EPR use.

• Teaching organizations at high school and university level may become more effectively supported in their focus on teaching their students documentation in both theory and practice as well as the connectivity between structured EPR use for documentation and an improved level of patient safety.

• System vendors may gain more knowledge of the complexity of nursing staff practices and the fact that implemented EPR systems still do not meet the needs for documentation and information exchange but continue to pose risks of adverse events.

• Health service leaders and ICT leaders should pay close attention to system implementation and adoption phases: This study shows the need for these leaders to pave the path for their staff members and not to underestimate the complexity in documentation and information exchange in their caring units: all in order to secure and improve patient safety.

• Staff members and healthcare students may learn how colleagues and co-students experience their EPR documentation practice, engaging in reflection about their own situation regarding patient safety and EPR use.

• Teaching organizations at high school and university level may be better supported in their focus on teaching their students documentation in both theory and practice: This study could also deepen the understanding of the connectivity between structured EPR use for documentation and the necessary level of patient safety.

Data Availability Statement

The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation.

Ethics Statement

Ethical review and the approval was not required for the study on human participants in accordance with the local legislation and institutional requirements. The patients/participants provided their written informed consent to participate in this study.

Author Contributions

All authors listed have made a substantial, direct, and intellectual contribution to the work and approved it for publication.

Conflict of Interest

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Acknowledgments

We would like to thank our participants, students and nursing staff participants as well as their leaders for time spent in the focus group discussions: for sharing experiences and thoughts with the research team in order to achieve the results of the study.

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Keywords: electronic patient record, nursing, patient safety, primary health care, documentation, focus group

Citation: Bjerkan J, Valderaune V and Olsen RM (2021) Patient Safety Through Nursing Documentation: Barriers Identified by Healthcare Professionals and Students. Front. Comput. Sci. 3:624555. doi: 10.3389/fcomp.2021.624555

Received: 31 October 2020; Accepted: 17 May 2021; Published: 01 June 2021.

Reviewed by:

Copyright © 2021 Bjerkan, Valderaune and Olsen. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

*Correspondence: Jorunn Bjerkan, [email protected]

This article is part of the Research Topic

Personalized Digital Health and Patient-Centric Services

good-documentation-practices-gdocp-v-gdp-pharma

Good Documentation Practices (GDocP) | GMP Basics

Gmp basics of good documentation practices (gdocp).

Good documentation practice (GDocP) is a crucial component of regulatory compliance, including data integrity assurances.

Referred to in the industry as Good Recordkeeping Practice (GRK), the term good documentation practice generally involves adhering to ALCOA+ principles.

GRK/GDocP is mandatory to ensure that your documentation — and your products — meet industry standards. Meeting good documentation practice requirements is also an important part of fulfilling other legal responsibilities in the pharmaceutical & medical devices sectors.

Good Documentation Practice (GDocP) = Good Recordkeeping Practice (GRK  = an essential component of your overall pharmaceutical quality system (PQS) and quality risk management strategies (QRM).

It’s important to understand the REASONS for complying with ALCOA+ and other good recordkeeping principles.

GDP/GRK requirements are particularly important for batch release procedures and batch tracing recordkeeping, self-inspections/GMP audits, data entry, non-conformance issues or deviation events, root cause investigations and CAPAs, and product recalls of medicines and other therapeutic goods. (For online courses covering these topics, click here).

Good documentation practice is good business practice no matter what your organisation services, produces, or sells.

Good documentation practices includes but is not limited to ensuring the following requirements are met.

These requirements include controls and checks that all GMP activity data meets expectations for:

  • Data Integrity (protected, secure and backed-up data systems)
  • Contemporaneous recordkeeping (timely, immediately/real-time)
  • Legible/legibility
  • Identify of the person recording the information (readily identifiable as to who recorded the information, including never sharing login passwords or data system log-ins, no forging of signatures (even if requested), and other data integrity measures
  • Readily accessible when required
  • Initials and signatures of all employees, contractors and suppliers who fill in documentation
  • A secure database to match initials and signatures with the actual identity of the person who recorded the data
  • Data must not be able to be altered or erased once entered or recorded
  • No white-out is permitted in GMP facilities and no gel pens (specific writing instruments are designated in your SOPs and working instructions)
  • Specific rules must be followed when altering a record, such as a legible cross through of the data and the correction listed with your registered initials and the time/date (and reason for the change, depending on the recordkeeping requirements)

For GMP consultancy or GMP audit assistance, including quality management systems and data integrity consultancy, contact PharmOut’s leading consultants (international expertise in GMP industries and PICS compliance including QMS and audit failure recovery.

Benefits of Good recordkeeping/good documentation practice SOPs and training for employees

  • Recordkeeping procedures (SOPs) help organisations meet their PIC/S GMP/EU cGMP requirements.
  • These requirements include adhering to internationally accepted quality standards and regional laws, applying risk management principles and controls as appropriate to product type and patient safety, and gaining ISO certifications.

Reliable, accurate, consistently recorded information helps ensure product safety, quality and efficacy.

  • While recordkeeping procedures are an important part of ANY business — they are particularly crucial in pharmaceutical, veterinary medicine and medical device manufacturing industries in view of the potential risks to end-users of their products (i.e. consumers/patients, pets, or livestock).

Good documentation practices are also essential for attaining and sustaining ISO-9001 certification — or other ISO certifications specific to your industry, such as ISO/IEC 17025 (for laboratory testing and calibration standards) ;  ISO/IEC 27001 (for information security management system / ISMS ), or ISO 13485:2016 (for medical device manufacturing) .

good-documentation-practice-GDP-GDocP-ALCOA+

Recordkeeping Gaps and FDA Audit Findings & TGA Audit Findings

Recordkeeping/documentation citations.

You can nearly guarantee your documentation procedures, recordkeeping systems, and data integrity assurance measures will be targeted in your next GMP inspection/Regulatory compliance audit.

Breaches of GMP regulations in relation to documentation practices and data systems are frequently cited in audits by the FDA, TGA, EMA, MHRA, and other Regulatory Authorities. To avoid audit findings and citations — and the potential for having to implement a recall due to poor documentation practices — good recordkeeping is essential.

Good recordkeeping, the foundation of data integrity, requires managerial-level prioritisation of data governance measures.

Your entire organisation must stay up to date with their Good Documentation Practice training courses to ensure they are complying with regulatory expectations.

Keeping good records is the foundational activity of good manufacturing practice (GMP), starting at the product conception and design stage, and continuing through clinical trials or prototype testing, production, distribution, and post-marketing surveillance.

Good documentation practices are required throughout the product’s entire life cycle, including design stages, manufacturing and testing, batch release, warehousing and distribution, and post-marketing surveillance — even disposal.

Good documentation practice throughout your organisation can reduce your chances of releasing a substandard batch of medicines, or medical device product, into the pharmaceutical supply chain (and help you avoid a product recall).

Do you need to learn the GMP requirements for managing deviations & non-conformances , managing therapeutic goods product complaints , preparing for a product recall , or implementing an effective CAPA system ? Click here for online training for popular GMP industry education topics .

Who in an organisation must comply with Good Documentation Practice (GDP)/Good Recordkeeping Practice?

  • The requirement for Good Documentation Practice (GDP/GDocP) — also referred to as Good Recordkeeping (GRK) — applies throughout your organisation.
  • Adhering to ALCOA+ principles is mandatory during manufacturing and post-marketing activities.
  • Keeping good records, and ensuring data integrity requirements are met in the process, is particularly applicable to any activities involving receiving raw materials/incoming goods, quarantine, production, testing, packaging & labelling (serialisation), and warehousing and distribution.

Not only must your employees and contractors comply with ALCOA+ principles and Good Documentation Practice (GDP) guideline — so must your contractors, suppliers/vendors, and distribution personnel (e.g. warehouse workers, product transport companies, and other individuals and businesses involved in manufacturing, packaging, storage, transportation, logistics, and delivery).

Good recordkeeping is also mandatory for Complaints Management Systems, CAPA systems, and post-marketing surveillance activities (pharmacovigilance/adverse event reporting). Click here to learn about PQS & QMS system requirements for GMP sectors .

GMP Inspection findings & Audit Citations (Documentation)

How many audit citations are related to poor recordkeeping and GMP documentation practices?

Inadequate documentation practices and recordkeeping weaknesses are key targets for FDA inspections, TGA inspections and QMS audits.

For beginners | gmp basics for good documentation practices, gmp industry terminology for good recordkeeping, gdocp vs gdp (good documentation practice vs good distribution practice).

Before we discuss the basics of good documentation practices for beginners, good documentation practices should not be confused with good distribution practices (for which the acronym is GDP).

  • To avoid confusion, Good Documentation Practice should be referred to as GDocP — not GDP (or Good Recordkeeping/GRK is also acceptable).
  • However, some industry publishers still use the same acronym (GDP) for documentation practices as well as for distribution practices (an error).
  • Data Integrity is a measure on its own and is a separate yet related education topic for data collection, data analysis, data storage and retrieval for the documentation retainment duration expected according to Regulations.

A brief note about GxP Acronyms

  • GxP stands for various GMP guidelines or regulations, such as GWP (Good Warehouse Practice), GRK (Good Recordkeeping Practice), etc.
  • Double meanings for the acronym ‘GDP’ (GDP = GDocP vs GDP = Good Distribution Practice) could impact your quality management systems and guidelines.
  • Be sure to specify GDocP for good documentation practices — or refer to Good Recordkeeping Practice (GRK) instead, per PIC/S publication terminology and common uses .

GxP-guidelines-examples

Data Governance measures must be adequate to ensure good recordkeeping practice & data integrity.

Regulatory Authorities/Competent Authorities around the world expect high-level commitment to data governance measures (i.e. Management commitment, evidenced by actions and company-wide communications). These measures generally include ensuring data integrity is maintained, such as by training personnel in GDocP, validating computer systems and electronic record storage equipment and systems over time, timely mon itoring of data entries, and continuous improvement initiatives in regard to recordkeeping and data storage and retreival systems.

Aim and purpose of good documentation practices (GDocP)

Gdocp/grk in pharmaceutical and medical device manufacturing.

  • If you’re new to GMP (or new to working in a regulated sector/manufacturing sector), you can learn more about GMP through PharmOut’s PIC/S Annexes/GMP compliance training store .
  • Visit the short online course for Good Documentation Practice/ Good Recordkeeping Practice (GRK)  compliance training/presentation .

Online GMP courses are typically available immediately upon completion of the online order. These courses will help you (and/or your new employees or contractors) better understand GMP compliance guidelines and industry expectations.

General Documentation Requirements/Good Documentation Practices

In brief, Good Documentation Practice (GDocP) guidelines from organisations such as PIC/S aim to ensure globally-expected standards are met during ALL stages of manufacture and distribution of medicinal products (pharmaceuticals, medical devices, veterinary medicines, etc).

Summary of GMP, PIC/S and ISO 9001 documentation standards

Accepted standards for the ALCOA+ standards (repeated below), are used to assess recordkeeping and data storage/retrieval practices at an organisation. They are assessed during GMP and GxP Audits to ensure they meet expectations.

Complete the GMP Data Integrity training course & the Good Recordkeeping course by clicking here .  

What’s generally required for good documentation practices and data integrity assurances?

The list below is an overview, in brief, of what Regulatory Authorities expect (this equates to the requirements of ALCOA and ALCOA+).

  • recorded accurately
  • cross-checked for errors
  • not intentionally misleading (prevents fraudulent entries, editable entries)
  • identity of the person recording the data is known/readily understood
  • the identify of the individual keeping any record or performing data entry must be identifiable at all times, on all GMP documentation
  • there must be no ambiguity, whatsoever, as to who recorded the data
  • clarity of content (easily understood/accepted notations/formats/etc)
  • legible (readable by anyone, removing guesswork)
  • readily accessible
  • recorded at the time of the event (as close as practicable)
  • not recorded or edited after the event
  • the record must be an original (not a copy)
  • edited records must not be erased or changed without specific notations and leaving the original data intact (learn how to cross through errors in a GMP environment )

Regulatory expectations also include the following in terms of recordkeeping and data collection/storage and retrieval, for both paper-based systems and electronic systems (which must be validated):

  • Blockchain is increasingly being discussed as part of Pharma 4.0 innovations
  • watch for other new technology adaptations for GDocP as systems evolve
  • Especially given growing global concerns about counterfeit pharmaceuticals and cosmetic medicines and substandard medicines and fake antibiotics entering global pharmaceutical chains
  • GMP and GDocP requires no shared passwords (and high-tech digital security for data integrity purposes and data entry tracking/logging identification)
  • genuine, true data
  • validated and supported/witnessed; vs intentionally falsified
  • relevant to the reporting requirement
  • not changeable after original recordkeeping entry (extensively tracked changes)
  • information is recorded contemporaneously
  • prevents errors from human memory-reliance issues and prevents editing of original data

Documentation/manufacturing records must meet ALCOA+ standards.

gmp-basics-for-good-distribution-practices-GDP-GDocP

  • What does the “+” represent in ALCOA+?
  • Learn more about ALCOA+ .

Tips for beginners: additional information on the basics of Good Documentation Practice (GDocP)/GRK.

All personnel, including contractors, are responsible for following regulatory guidelines.

  • Expectations for GDocP/GRK compliance go well beyond being an organisation-wide requirement.
  • These expectations also apply to contractors, service vendors/maintenance workers, equipment installation engineers, raw material suppliers, and any other individuals or companies involved in your manufacturing, production, labelling/packaging operations (and supply chains).

It’s important to be aware of the compliance gaps that lead to GMP audit citations and/or audit failures (audit findings/citations/production line shutdowns and/or facility closures).

Documentation AND distribution practices are two key areas where companies often end up inadvertently breaching GMP requirements/PIC/S guidelines for documentation practices.

As the manufacturer (product sponsor), your organisation is ultimately responsible for ensuring EVERY person involved in the production and distribution of your products has attained appropriate GDocP compliance training (with proof, e.g. assessments/training certificates).

Documentation Audits & Inspection Findings

Averting GMP audit findings (GMP compliance breaches, e.g. to avert failing an ISO certification audit, or being subjected to a TGA warning letter/citation or an FDA warning letter /audit citation/fine):

  • GDocP compliance investigations need to be performed regularly
  • Management must provide/ensure adequate training and monitoring of documentation practices and quality systems, including those used by contractors, key suppliers, and transportation personnel
  • Data governance measures must be appropriate to risks
  • Computer systems / electronic data systems must be validated

Self-Inspections for GDocP compliance are recommended to be performed more frequently than your annual self-inspection requirement.

  • It may be beneficial to perform self-inspections of recordkeeping/documentation practices more frequently than your annual requirement.
  • Frequent self-inspections (internal GMP/GDP compliance audits) can help improve compliance, reduce risks, and provide ideas for continuous improvements — as well as ensuring your Pharmaceutical Quality System (PQS) is functioning as intended.

good-documentation-practice-gdocp-gdp-grk

Applicability of Good Documentation Practice (GDP) Guidance by PIC/S

  • Good documentation practices (requirements) apply to nearly all delivery regions and countries.
  • While PIC/S guidelines aim to ensure global consistency in terms of manufacturing standards, some regions may have slightly different documentation requirements — DO check before you ship.

Digital recordkeeping systems

If you’re relying on any type of digital recordkeeping system, you must ensure your computerised systems and data collection/data analysis processes are validated according to GMP guidelines/regulatory expectations.

Ensure you comply with data integrity requirements.

Documentation Types | Good Documentation Practices

What types of documents or recordkeeping is required in the pharmaceutical industry or in the production of medicinal cannabis, medical devices, blood and tissue products and veterinary medicine production?

Examples of records for which employees/contractors and suppliers must adhere to good documentation practices (GDocP as part of GMP including GDP or distribution ) include, but are not limited to:

  • Analytical Methods
  • Annual Self-Inspection (Procedures, Implementation and Findings/Actions)
  • Batch Records / Supply Sources
  • Bills of Materials (BOMs)
  • CAPA (Corrective Actions and Preventative Actions)
  • Clinical Study Records
  • Cold Chain reports and climate testing measurements/records
  • Complaints and complaint handling/monitoring
  • Continuous Improvements
  • Certificate of Analyses (CoA)
  • Certificate of Compliance (CoC)
  • Distribution records including Routes, Storage and Delivery Records
  • Incident Reports
  • Laboratory Notebooks / Logbooks
  • Labels (Product Labels and sampling labels)
  • Non-conformances
  • Policies (documentation including approvals and distribution/employee training records)
  • Protocols and changes to protocols (change management system documentation including approvals)
  • Quality management records / QMS systems
  • Recalls and Recall Policies
  • Releases (QMS approvals by trained, competent and authorised personnel)
  • SAE reporting (serious adverse events reporting)
  • Source suppliers and source supply testing/monitoring
  • Standard Operating Procedures
  • Test Methods / Quality Testing methods including validation and recordkeeping
  • T raining | GMP training for Employees, Contractors, Suppliers/Vendors including your distribution/warehouse and transportation personnel or contractor(s)
  • Work Instructions (Workflow, procedures, SOPs)
  • Workplace Safety reports/record keeping
  • Validation (methods, reports and related documentation including IQs, OQs and PQs)

GMP Recordkeeping Categories

Documents and records can fall into various classification systems, and in general, there are 4 key classifications for documentation.

  • Primary Records (examples: production formulas, supply source documents, contracts, packaging instructions)
  • Procedures or supporting procedures (instructions and guidebooks, SOPs)
  • Subsidiary records (help meet GMP, e.g. calibration readings reports, print outs, other supporting documents)
  • Quality Control records (testing results, testing methods, recall procedures, investigations, self-inspection reports, CAPA, more)

GDocP | What are the specific requirements for good documentation practices in pharmaceutical production including medicinal cannabis and other herbal medicines, veterinary medicines and medical device manufacturing?

Check your organisations SOPs (Standard Operating Procedures) and work instructions for details.

Basic requirements for good documentation practices will include, but not be limited to, the following components:

  • Readily identifiable as to who recorded it (no shared passwords or shared data system log-ins, no forging of signatures even if requested)
  • initials and signatures of all employees, contractors and suppliers who fill in documentation
  • a secure database to match initials and signatures with the actual identity of the person who recorded the data

We have online training for GDocP as well as custom onsite courses and upcoming GMP course training dates .

Good Documentation Practice (Summary)

Gdocp/grk training, and recordkeeping compliance monitoring, in conjunction with other data governance measures, can help reduce your risks of ‘failing’ a gmp compliance audit..

Just remember that good recordkeeping requirements apply to everyone in your distribution supply chain, not just manufacturing-site personnel.

It is applicable to your casual workers/contractors, contract service providers, source material/API suppliers, warehouse workers, and transport/delivery organisations.

All people who have contact with your product, at any stage of production or delivery:

  • require documented, ongoing training in GDocP/GRK compliance
  • are expected to be monitored for GMP/GxP compliance
  • should understand how to identify potential issues with records/data integrity

The FDA and TGA will likely investigate your employee records, and the documentation practices of your suppliers and service providers — including contractors — and they’ll do so in-depth!

That’s because good documentation practices are part of the 10 golden rules of GMP .

References, Sources and Further Reading

The Food and Drug Administration (FDA or Agency) – December 2018 (‘‘Data Integrity and Compliance With Drug CGMP: Questions and Answers’’ PDF)

Other Training Bundles

Or for individual or onsite training courses, review GMP training courses by PharmOut’s GMP Training, learning and development expert , Maria Mylonas and other GMP manufacturing and medicinal cannabis TGA industry experts.

References:

Warehouse, Distribution and GMP Training for Transportation employees and Outsourced contractors (Training)

FDA Good Documentation Practices (FDA GDP)

TGA Good Record Keeping / GDocP

For GMP consultancy and/or GMP audit assistance, validated quality management systems (QMS) and other data integrity or production engineering and distribution practice consultancy, visit PharmOut’s site .

You can also browse our top online GMP training courses for industry-specific training, available in bundles.  Onsite custom courses by Maria Mylonas are also available at your facility anywhere in the world .

Page last updated: October 17, 2022 .

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  • 21 CFR Part 11 and Good Documentation Practices in Pharmaceutical Industries

It has been said that in the pharmaceutical industry, “If it isn’t documented, it didn’t happen.”

Documentation control is not optional; it is a legal requirement. For this reason, good documentation practices–commonly referred to as GDPs–are critical. Records and reports, along with procedures, “tell the story” of manufactured products and devices. Those working in the pharmaceutical and other healthcare sectors must have “good” documentation practices to ensure the integrity and reliability of data.

Table of Contents

Good Documentation Practices at a Glance

GDP lays down the guidelines for preparation, recording, and correction of data as well as the maintenance of the records throughout the lifecycle of a document. It recommends that the records should be made or completed at each time any action is taken. Each activity should be written in specific SOPs and are strictly followed as per the norms; from the initial data generation to recording and processing, use, retention, archiving, and retrieval. It determines the extent to which data should be integral, complete, considerate, consistent, and accurate throughout the lifecycle. Data integrity is an essential component of the industry’s responsibility to ensure the safety, efficacy, and quality of drugs, and of FDA’s ability to protect the public health. It has always been and currently is a primary global concern for the pharmaceutical industry.

The FDA and 21 CFR Part 11

Via 21 CFR Part 11, the FDA regulates electronic signatures and electronic records (ESER) that implement the controls, audits, system validations, audit trails, electronic signatures, and documentation involved in processing the electronic data. It emphasizes product quality and compliance with the regulations. If electronic records and electronic signatures are illegible, inaccessible, or corrupted, manufacturers are still subject to those requirements.

In March 1997, the United States FDA issued regulations that established the criteria for acceptance of electronic documents by the FDA for electronic records, electronic signatures, and handwritten signatures.

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Industry Incidents

“New England Compounding: Meningitis Outbreak in 2012, Pharmacy technicians prioritized production over the cleaning and disinfecting, which showed falsified clean rooms when they had not been. This neglect reported fatal results leading to 64 deaths and sickening of 800 patients. The president sentenced to 9 years in prison, and other employees were being charged with multiple criminal acts. This incident led to increased FDA oversight.”

Sun Pharmaceutical’s Halol unit, in Gujarat, and Dr Reddy’s plant in Visakhapatnam, Andhra Pradesh, got 432 and 474 letters back then, which they had to resolve, without delaying the whole process for much longer.

“Apart from actual quality issues, the US FDA has also pointed out that data integrity is an issue with Indian drug firms,” said Meghana Inamdar, an international commercial lawyer at Mumbai-based consultancy Sidvim Lifesciences.

Further research shows in 2016, India and China were the main targets of FDA inspections and 80% of the FDA warning letters were issued in 2016 that had Data Integrity deficiencies.

In light of past incidents, any FDA regulation that requires companies to maintain certain records and submit information to the agency as part of compliance must follow GDP regulations such as GLP (Good Laboratory Practices), GCP (Good Clinical Practices), and CGMP (Current Good Manufacturing Practices).

Although predicate rules were initially meant to apply to paper records (which required handwritten signatures), these rules remain applicable even when you use electronic records and signatures. In this case, 21 CFR Part 11 then becomes an additional requirement for e-records and signatures. Part 11 requirements are not meant to replace or override other FDA (GDP, GLP, GCP, CGMP) regulations regarding signatures and records. Electronic signatures and handwritten signatures executed to electronic records shall be linked to their respective electronic records to ensure that the signatures cannot be excised, copied, or otherwise transferred to falsify an electronic record by ordinary means.

Many pharmaceutical industries have received warning letters from the FDA for not being compliant with Good Documentation Practices or not being compliant with 21 CFR Part 11. Consequences of these activities lead to penalties and, in some cases, legal action against the organization. Following the GDP practices will ensure quality standards and the delivery of quality products to consumers.

While our focus is on medical device organizations and the compliance of their quality systems with this regulation, the rules also apply to small and large pharma companies, biotech firms, biologics developers, drug manufacturing operations, quality control labs, clinical trials in pharma, and other FDA-regulated industries.

Some of the documentation errors that commonly appear in the FDA are: Missing documents, falsified data, illegible data, missing signatures on the documents, documents with missing/false date, time and version number, no raw data to support records, creating inaccurate and incomplete records, fabricating (invalid) data, discarding (unwanted) data, inadequate investigations, deletion/manipulation of data, incorrect and incomplete validation, no audit trail, loss of data, activities not recorded, no authentication provided and so on.

The following are some document examples: Batch manufacturing records, bills of material, SOPs, protocols, forms/log sheets, training assessments, certificate of analysis, technology transfer documents, maintenance records, calibration records, clinical trial records, change controls, instrumentation records, policies, test methods, specifications, product and sample labels, training documentation, test methods.

MSB Docs for GDP and 21 CFR

MSB Docs truly follows GDP guidelines, regulations, and is FDA compliant. MSB’s approach to data protection is rigorous, as evidenced by our comprehensive security features.

MSB’s documentation methods are also compliant with ALCOA:

  • Attributable: Information of the signer is duly captured in the records, and he is uniquely verified with a full robust authentication mechanism.
  • Legible: Documents stored in MSB Docs are readable, understandable, and allow complete tamper proof details of the user who signed or reviewed the document and many other considerable actions.
  • Contemporaneous: This is the record at the time data is generated. MSB Docs plays a substantial role in providing a comprehensive audit trail of the document. Sender and signer activity are both measured along with the time stamping details of the document and the complete log of the signing process.
  • Original: Data in the form in which it was originally generated. MSB Docs provides signers the real electronic copy of the signed document.
  • Accurate: MSB Docs provides correct, truthful, complete, valid, and reliable data.

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For firms to reduce regulatory risks and operate under FDA compliance proactively, MSB Docs easily provides digital data security for regulatory compliance, financial and secure transactions, and evidence for legal purposes. We uphold strict standards, legal enforceability, and thorough compliance. Our electronic signatures are trustworthy, reliable, and equivalent to handwritten records.

MSB Docs maintains data integrity, makes internal audit procedures adequate, and accurately reports events. It also accurately calculates, interprets, and reports data via documentation of actions and storage.

In a Nutshell

For any company that maintains electronic records, understanding the predicate rules found in GDP, and other FDA regulations that require record retention and submission is key to 21 CFR Part 11 compliance efforts. MSB specializes in helping companies of all sizes achieve and maintain the most rigorous levels of compliance.

Contact us today to learn more and to schedule a demo with one of our solution experts.

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Home › What is Documentation? › 6 Good Documentation Practices in 2024

6 Good Documentation Practices in 2024

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Technical documentation requires years of experience and expertise on the subject matter, especially if you’re working in complex fields like industrial, medical, computer science, and other similar industries. That’s why you need to follow good documentation practices.

There’s a difference between best practices for technical writing and good documentation practices. It’s crucial to understand that difference as a technical writer because it will help you develop better technical documentation.

In any case, keep in mind that you need to understand good documentation practices to further your technical writing career. If you’re interested in learning more via video, then watch below. Otherwise, skip ahead.

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In this article, we’ll go over what good documentation practice is, along with the factors of good documentation practices in 2024.

Let’s dive right in.

What Exactly Are Good Documentation Practices (GDocP)?

Good documentation practices, otherwise known as GDocP, is an industry-recognized technical documentation creation, maintenance, and development standard.

You can’t put it under the general best practices of technical documentation because it is a specific method of developing documentation. It follows and very specific list of standards that need to be followed by whoever’s developing the documentation. It’s widely used in the pharmaceutical industry and the medical devices industry.

When you’re publishing documentation, you need to follow the GDocP checklist requirements to meet the industry standards. Otherwise, your technical documentation will not be approved and official.

The pharmaceutical and medical device industry already has good manufacturing practices (GMP). That’s mostly because of the Current Good Manufacturing Practice (CGMP) regulations that are enforced by the FDA (Food and Drug Administration).

Additional regulations include the 21 CFR Part 11 that regulates electronic data, electronic signatures and electronic records (ESER), and CAPA (Corrective and Preventive Actions).

Similarly, you’ll find that there is also Good Clinical Practice (GCP) and Good Laboratory Practice (GLP).

All four of them, including Good Documentation Practice, Good Clinical Practice, Good Manufacturing Practice, and Good Laboratory Practice, fall under the concept of GxP in pharmaceuticals. GxP is officially a collection of regulations and quality guidelines to ensure healthcare products are safe.

Some quality management systems also include Good Storage Practice (GSP) and Good Review Practice (GRP) in the mix too.

Along with the GxP quality control concept, a regulatory agency also includes standard operating procedures (SOPs) for the organizations.

To maintain a good record, audit trails, be attributable, and complete regulatory requirements, it’s essential to have good documentation practice. To become an expert at good documentation practices, check out our technical writing certification course.

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6 Principles of Good Documentation Practices as of 2024

The initial good documentation practice was based on ALCOA – it’s now abbreviated into the acronym, ALOCA-C. They stand for:

  •       Attributable
  •       Legible
  •       Original
  •       Contemporaneous
  •       Accurate
  •       Complete

Each aspect covers the fundamentals of technical documentation in the healthcare industry. They should be covered when you’re developing your computer systems, record-keeping systems, logbooks, and more.

It’s crucial to follow these six principles to maintain batch records, clinical trial records, increase traceability, improve data entry systems, making healthcare issuance easier, develop laboratory notebooks, and adhere to ISO standards, among other things.

In any case, here’s what each of the six good documentation practices entails.

Attributable

The first principle states that all the documentation should be immediately identifiable and attributable. That means you should immediately be able to see who created, recorded, and developed it.

Furthermore, it also includes any precautions that have been taken against the forgery and/or falsification of those details.

The second principle is mostly about having great technical writing skills and abilities. That means you should have a strong command of the sentence structure, tone, grammar, and format.

Therefore, all the stored documentation needs to be completely legible and easy to understand. The more decipherable and unobscured it is, the better.

The idea is to develop documentation for the common person. As a result, anyone who decides to read up on the documentation can easily understand all aspects of it to the point where they can relay the information forward.

It’s absolutely crucial to maintain the originality of your documentation. That means you should always have original copies of your documentation in your computer systems.

It helps improve your confidentiality and guarantees the accuracy of the documentation.

That doesn’t mean you can’t develop and use photocopies. You can still make as many photocopies and printouts as you want, but you always need to have the original in your system.

Contemporaneous

For any sort of technical documentation, it’s crucial for it to be contemporaneous. All the documentation should demonstrate contemporaneous record-keeping.

That means that all the relevant documents need to be accurately dated and time-stamped when they’re created, developed, published, and updated.

As a result, you’ll have the entire history of the document design, development, testing, production, and decision-making process at your disposal. It makes all the relevant information regarding end products completely traceable. Therefore, it would be easier to audit the document, update it, and more.

Maintaining data integrity is one of the most critical aspects of technical documentation. All the processes and procedures that go into the recording, development, and storing of the documentation need to be straightforward, accurate, and precise.

They have to be designed to ensure and maximize accuracy and reliability. Usually, there are second-person checks to see if the data is accurate. It’s especially needed when there is a lot of raw data, and it needs validation.

In any case, you have to develop all your processes to maintain data integrity, maximize data reliability, and maximize the retention period.

Lastly, the final principle is to have the entirety of your process and documentation noted down. That means your maintenance and storage of all the required documentation should be complete and top-notch, such that it encompasses the entirety of your process.

To do that, you need to pay extra attention to the point of data integrity. For that, you have to keep the following points in mind.

  •       The data in the documentation can and must not be altered, modified, or erased once it is entered or recorded. If, in any case, you need to make any changes or delete the data, you need to get the appropriate permissions from the stakeholders.
  •       Every single part of the document should be secured, protected, and stored in backup data systems. It’s best to have cloud-based systems so you can access the document at any time. More importantly, you have to make sure the documentation is secure from any unwarranted access attempts.
  •       There’s also a need for a well-designed system for keeping a check on the login system. There shouldn’t be any shared passwords or share data system logins to avoid any issues. Furthermore, signature forging shouldn’t be possible, especially because of the FDA’s ESER regulations.

In any case, all your technical documentation should be absolutely complete, including the data, procedures, and backups, according to good documentation practices.

Good Documentation Practices Requirements

Good documentation practice requirements

Now that you have a good idea of the principles of good documentation practices, you can look into the requirements. Generally, the requirements may change depending on the industry and may require custom calibration in some cases. However, mostly, the requirements remain the same.

In any case, here are the parts of GDocP that are applicable in all cases.

  •       Documentation Creation: All documentation creation should be absolutely accurate and legible. It should also be timely; that means it should be up to date with any recent updates and occasions. Most importantly, all the data used during documentation creation should be verified from all fronts.
  •       Documentation Review Cycles: Every document that is part of the technical documentation should be reviewed multiple times by various stakeholders. They need to be individually verified and signed by authorized personnel. If there’s an issue, the document is to be rewritten so it can go through the review cycles again.
  •       Documentation Maintenance: Every technical documentation needs to be maintained to stay relevant. To do that, you have to regularly review the document to make sure it’s still relevant. If it’s not, you have to update it to make sure it’s up to date. Most importantly, the updated version needs to be backed up appropriately.
  •       Documentation Modifications: You need to keep a record of and maintain all the audit trails, including the reasons for modifications. Furthermore, the documentation needs to have administrative controls of the modification process and the reasons behind the modifications.

Understanding and adhering to good documentation practices not only ensure you’re doing everything according to regulations but also helps you keep track of everything and do it right.

Using Good Documentation Practices in 2024

Nowadays, if you make a mistake in the documentation, you would directly receive a single-line warning letter, and then you will face a penalty.

Good documentation practices help protect you from all forms of unforeseen issues. They protect your organization, personnel, and your users. Most importantly, they help you stay compliant with state and federal laws and regulations.

Using good documentation processes will reduce your compliance risk, improve data backups, and make it easy to develop technical documentation for your organization. Mix that up with some great documentation formatting examples , and you’ll end up with excellent documentation.

Make sure you have a good idea about the principles of good documentation practices and their requirements. If you use technical documentation best practices along with good documentation practices, you’ll be developing the ideal documentation for your company and product. 

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GOOD DOCUMENTATION PRACTICES AND PRACTICAL CASE STUDIES

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Description:

Documentation is a regular essential feature in all phases of day-to-day activities. Most of the time we do it unknowingly as in many cases it remains concealed as a part of the total assignment. If we analyze successful case studies either of a person or of any event, it is observed that good documentation has played a major role in achieving this success. When we read, we see, we listen, actually what process we undergo? We transfer the information from other field to our memory. This is also documentation, by which we acquire and keep useful information in our memory. It is also the tool, which governs the entire system/proceedings and provides guidance to over come the unexpected hold ups during any process. Here is a unique example, which indicates how important is the documentation to human beings. We often talk about intelligence. What is intelligence? It is the capacity to manage a situation favorably and amicably. This quality person doesn’t posses at birth. During the various stages of any life cycle the information received is documented systematically in memory and retrieval of right information at the right moment for application purpose, is key feature of intelligence. This skill obviously needs good documentation practices. From this, it is evident that good documentation doesn’t mean the possession of information; it means storage of information in a systematic manner, understanding the significance and application of the same by timely retrieval. The purpose of this presentation is to discuss on:

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good documentation practices case study

Good Documentation Practices and ALCOA-C

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good documentation practices case study

IMAGES

  1. presentation on good documentation practices

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  2. Learn What is Good Documentation Practices GDP in 4 Steps?

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  3. Good documentation practices

    good documentation practices case study

  4. presentation on good documentation practices

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  5. PPT

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  6. Good Documentation Practices -Do's and Don'ts- (GCP)

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VIDEO

  1. Case Studies

  2. Demo Case Study

  3. Good documentation practices "GDP" and GMP , definition, importance, principles مبادئ التوثيق الجيد

  4. Case study presentation

  5. DPP30033 EXPORT AND IMPORT PRACTICES (case study)

  6. Good Documentation Practices (GDP)

COMMENTS

  1. Good documentation practice in clinical research

    The importance of good documentation practice needs to be emphasized to investigator sites to ensure that the study results are built on the foundation of credible and valid data. This article focuses on the key principles of good documentation practice and offers suggestions for improvement. Keywords: ALCOA, documentation, source, training Go to:

  2. Good Documentation Practices (GDP)

    Good Documentation Practices (GDP) is a term used by the pharmaceutical, laboratory and manufacturing industries to describe best practices surrounding the creation and maintenance of documentation (in both paper and electronic format). ... and includes records and documentation of study observations, activities and data. Key attributes of ...

  3. Let The Document Tell The Story: Document Management Best Practices

    Let The Document Tell The Story: Document Management Best Practices Written by: Etienne Nichols March 11, 2022 Good stories follow a 3-act structure: Act 1: Set up Act 2: Conflict Act 3: Resolution "Thanks a lot, Aristotle, but we're interested in documentation, not story-telling."

  4. Good Documentation Practices (GDocP), Definition, Principles

    FDA definition of good documentation practices. The Food and Drug Administration (FDA) provides a clear definition of good documentation practices in the context of the pharmaceutical and medical device industries. According to the FDA, GDocP is the set of standards by which documents are created, modified, maintained, and archived. (To avoid confusion, it's worth saying that the acronym GDP ...

  5. What Makes a Well-Documented Notebook? A Case Study of Data Scientists

    A Case Study of Data Scientists' Documentation Practices in Kaggle ... together (computational narrative), and support rapid iteration on code experiments. However, it is not easy to write good documentation in a data science notebook, partially because there is a lack of a corpus of well-documented notebooks as exemplars for data scientists ...

  6. Good Documentation Practices Examples

    Article by SafetyCulture Content Team | 11 min read What is Good Documentation Practices? Good documentation practices is a set of best practices for documentation and recordkeeping. It aims to preserve the data integrity of important documents and records and can also serve as guidelines for how to record information and store data appropriately.

  7. Good Clinical Practice Study Documentation

    Good Clinical Practice Study Documentation The Department of Medicine Clinical Research Unit has prepared this document is to provide guidance to all faculty and staff involved in the conduct of research on the best practices related to documentation.

  8. Frontiers

    Introduction High-quality patient documentation in primary care is crucial for ensuring the quality of care, continuity of care, and patient safety. For many years, the quality of nursing documentation has been reported as inadequate ( Hellesø and Ruland, 2001; Blair and Smith, 2012; Akhu-Zaheya et al., 2018 ).

  9. Good Documentation Practices (GDocP)

    Good documentation practice (GDocP) is a crucial component of regulatory compliance, including data integrity assurances. Referred to in the industry as Good Recordkeeping Practice (GRK), the term good documentation practice generally involves adhering to ALCOA+ principles.

  10. PDF ALCOA + C

    that case, use quotations and attribute the remarks appropriately. o Don't attribute thoughts, feelings, or intentions, to other persons (includes subjects, providers, spouses, parents, etc.). • Don't write retaliatory or critical comments about clients or care by other health care professionals (including sponsors).

  11. (PDF) Good documentation practice in clinical research

    The importance of good documentation practice needs to be emphasized to investigator sites to ensure that the study results are built on the foundation of credible and valid data. This article ...

  12. PDF Revision #: Good Documentation Practices

    Good Documentation Practices Revision #: 1 Effective Date: 01SEP2021 Page 1 of 7 . 1. Purpose ... Clinical study staff are required to follow this procedure when they are providing documents to the ... In this case, the program setting must be used. 6.8.3. The time should be formatted based on a 24-hour clock or military time. Examples are ...

  13. PDF Essential Documents

    Essential Documentation will vary from study to study. Federal oversight (HHS vs. FDA) Industry vs. PI-initiated. Use of investigational product. Funding source. Nature of the study. Required documents vs. good practice. "Essential Documents are those that individually and collectively permit evaluation of the conduct of a study and the ...

  14. Good Documentation Practices in Pharmaceutical Industries

    Those working in the pharmaceutical and other healthcare sectors must have "good" documentation practices to ensure the integrity and reliability of data. Table of Contents Good Documentation Practices at a Glance

  15. 6 Good Documentation Practices in 2024

    It's crucial to follow these six principles to maintain batch records, clinical trial records, increase traceability, improve data entry systems, making healthcare issuance easier, develop laboratory notebooks, and adhere to ISO standards, among other things. In any case, here's what each of the six good documentation practices entails.

  16. Good Documentation Practices for Clinical Research

    One person should be responsible for submission of study data for each patient's study visit. In real-time, have clinicians sign any forms requiring signatures. Do not combine subjects' files. Promptly submit data. Legible, Accurate and Complete. Do a careful review of completed CRFs prior to entry. Don't guess.

  17. PDF Good Documentation Practices

    Good documentation practices follow to protect the integrity and quality of all documents/records, electronic and handwritten, used in different GMP operations and activities and ensures these records are truthful, readily retrievable and traceable. ... In case continuous pages of a notebook are not being used to record data, continuity

  18. Good documentation practice in clinical research : Perspectives in

    The importance of good documentation practice needs to be emphasized to investigator sites to ensure that the study results are built on the foundation of credible and valid data. ... Inadequate/inaccurate case histories form the second most commonly cited deficiency in US-FDA inspections of clinical investigator sites. ... Sponsor/CRO should ...

  19. Good Documentation Practices and Practical Case Studies

    Description: Documentation is a regular essential feature in all phases of day-to-day activities. Most of the time we do it unknowingly as in many cases it remains concealed as a part of the total assignment. If we analyze successful case studies either of a person or of any event, it is observed that good documentation has played a major role ...

  20. PDF Good Documentation Practices (GDocP)

    Definition Documents: • Approved instruction either in paper or electronic form which guides about how an activity shall be executed. Records: It provide evidence that activities have been performed or results have been achieved. Record is often considered as document. They always document the past. Aim and purpose of GDP

  21. Good Documentation Practices (GDP)

    Good Documentation Practices (GDP) are the measures that collectively and individually ensure documentation, whether paper or electronic, is secure, attributable, legible, traceable, permanent, contemporaneously recorded, original, and accurate. ... Download Full Case Study (PDF Format) First Name * Last Name * Email * Dallas - Corporate Office ...

  22. Good Documentation Practices and ALCOA-C

    In this course, you will learn about Good Documentation Practices, including the ALCOA-C principles, notes to file, and other general documentation procedures. ... The programs further offer access to regulatory references, real-life case studies, and introduce other important information necessary to assist with learning. Since 2003, Biopharma ...