good documentation practices in clinical research

Good documentation practice in clinical research

Perspectives in Clinical Research 2(2):59-63

Lupin Pharmaceuticals, Inc.

Discover the world's research

25+ million members
160+ million publication pages
2.3+ billion citations
Kristin N Slater

Maroju Manasa Priya

Shaikh Mohmed
Srinivasarao Varagani
Harry van Loen

Yven Van Herrewege

Natnaree Girdthep
Rebekah Frankson
Kerstin Gierend

CTS-CLIN TRANSL SCI
Bryan Oronsky
Erica Burbano
Meaghan Stirn
Sisay Yitayih Kassie

Preeti Kulkarni
Charmy Kothari

Kalvin Nash

Raymond Nomizu
Guidance On
Clinical Trial Inspection-Cdsco
Recruit researchers
Join for free
Login Email Tip: Most researchers use their institutional email address as their ResearchGate login Password Forgot password? Keep me logged in Log in or Continue with Google Welcome back! Please log in. Email · Hint Tip: Most researchers use their institutional email address as their ResearchGate login Password Forgot password? Keep me logged in Log in or Continue with Google No account? Sign up

An official website of the United States government

The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Publications
Account settings
My Bibliography
Collections
Citation manager

Save citation to file

Email citation, add to collections.

Create a new collection
Add to an existing collection

Add to My Bibliography

Your saved search, create a file for external citation management software, your rss feed.

Search in PubMed
Search in NLM Catalog
Add to Search

Good documentation practice in clinical research

Affiliation.

1 Department of Clinical Trials and Safety, Global Quality and Regulatory Compliance, Bristol Myers Squibb, Mumbai, India.
PMID: 21731856
PMCID: PMC3121265
DOI: 10.4103/2229-3485.80368

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.

Keywords: ALCOA; documentation; source; training.

PubMed Disclaimer

Related information

PubChem Compound
PubChem Substance

LinkOut - more resources

Full text sources.

Europe PubMed Central
Medknow Publications and Media Pvt Ltd
Ovid Technologies, Inc.
PubMed Central
Citation Manager

NCBI Literature Resources

MeSH PMC Bookshelf Disclaimer

The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Unauthorized use of these marks is strictly prohibited.

Skip to main content
Skip to FDA Search
Skip to in this section menu
Skip to footer links

The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

U.S. Food and Drug Administration

Search
Menu
Science & Research
Science and Research Special Topics
Clinical Trials and Human Subject Protection

ICH Guidance Documents

ICH E3: Guideline for Industry Structure and Content of Clinical Study Reports (PDF - 240KB)

This International Conference on Harmonization (ICH) document makes recommendations on information that should be included in a core clinical study report of an individual study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects. The guideline is intended to assist sponsors in the development of a report that is complete, free from ambiguity, well organized and easy to review.

ICH E3 Questions and Answers (PDF - 141KB)

ICH E5: Ethnic Factors in the Acceptability of Foreign Clinical Data (PDF - 89KB)

This International Conference on Harmonization (ICH) document makes recommendations for strategies to permit clinical data collected in one region to be used to support drug and biologic registrations in another region while allowing for the influence of ethnic factors.

ICH E5 Questions and Answers (PDF - 48KB)

ICH E6: Good Clinical Practice: Consolidated Guidance (R2- Integrated Addendum) (PDF - 484 KB)

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve human subjects. Compliance with GCP assures that the rights, safety, and well-being of trial subjects are protected and that the clinical trial data are credible. This International Conference on Harmonization (ICH) guidance provides a unified standard for the European Union, Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in those jurisdictions.

ICH E7: Studies in Support of Special Populations: Geriatrics Questions and Answers

This ICH guidance provides recommendations on special considerations that apply in the design and conduct of clinical trials of medicines that are likely to have significant use in the elderly. This question and answer (Q&A) document is intended to clarify key issues.

ICH E10: Choice of Control Group and Related Issues in Clinical Trials (PDF - 93KB)

This International Conference on Harmonization (ICH) guidance addresses the choice of control group in clinical trials, discussing five principal types of controls, two important purposes of clinical trials, and the issue of whether a trial could have detected a difference between treatments when there was a difference (assay sensitivity).

ICH Q9: Quality Risk Management (PDF - 113KB)

The purpose of this document is to offer a systematic approach to quality risk management. It serves as a foundation or resource document that is independent of, yet supports, other ICH Quality documents and complements existing quality practices, requirements, standards, and guidelines within the pharmaceutical industry and regulatory environment. It specifically provides guidance on the principles and some of the tools of quality risk management that can enable more effective and consistent risk-based decisions, by both regulators and industry, regarding the quality of drug substances and drug products across the product lifecycle. It is not intended to create any new expectations beyond the current regulatory requirements

VICH GL9: Good Clinical Practice (PDF - 64KB)

The objective of this document is to provide guidance on the design and conduct of all clinical studies of veterinary products in the target species. It is directed at all individuals and organizations involved in the design, conduct, monitoring, recording, auditing, analysis and reporting of clinical studies in target species and is intended to ensure that such studies are conducted and documented in accordance with the principles of Good Clinical Practice (GCP). Good Clinical Practice is intended to be an international scientific quality standard for designing, conducting, monitoring, recording, auditing, analyzing and reporting clinical studies evaluating veterinary products. This guidance has been developed under the principles of the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) and will provide a unified standard for the European Union (EU), Japan and the United States of America (USA) to facilitate the mutual acceptance of clinical data by the relevant regulatory authorities. This guidance was developed with consideration of the current practices in the EU, Japan and the USA together with those of Australia and New Zealand.

Documentation: Essential Documents and Standard Operating Procedures

Living reference work entry
First Online: 08 November 2019
Cite this living reference work entry

good documentation practices in clinical research

Eleanor McFadden 3 ,
Julie Jackson 3 &
Jane Forrest 3

514 Accesses

Documentation is a critical component of clinical trials. There are requirements not only to be able to verify that the data being analyzed is accurate but that it was collected and processed in a consistent way. Anyone involved in a trial has to recognize the documentation requirements and ensure that they are met. The International Conference on Harmonization (ICH) Guidelines on Good Clinical Practice E6 provides details of standards to be met along with relevant definitions. This chapter provides guidance on identifying essential documents for a trial and also on how to develop and maintain systems for standard operating procedures.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Institutional subscriptions

Data Capture, Data Management, and Quality Control; Single Versus Multicenter Trials

How to Maintain Excellent Clinical Documentation

Ben-Yehuda N, Oliver-Lumerman A (2017) Fraud and misconduct in clinical research: detection, investigation and organizational response. University of Michigan Press. ISBN – 0472130552, 9780472130559

Google Scholar

DIA TMF (2018) Reference Model. Retrieved from: https://tmfrefmodel.com/resources/

Ellenburg S, Fleming T, De Mets D (2003) Data monitoring committees in clinical trials. Wiley, New York

Good Clinical Practice Guidelines, E6 (R2) (2016). Retrieved from: http://www.ich.org/products/guidelines/efficacy/efficacy-single/article/integrated-addendum-good-clinical-practice.htmlICH GCP Guidelines/

McFadden E et al (2015) The impact of registration of clinical trials units: the UK experience. Clin Trials 12(2):166–173

Article Google Scholar

Weiss RB (1998) Systems of Protocol Review, quality assurance and data audit. Cancer Chemother Pharmacol 42(Suppl 1):S88

Article MathSciNet Google Scholar

Download references

Author information

Authors and affiliations.

Frontier Science (Scotland) Ltd, Grampian View, Kincraig, UK

Eleanor McFadden, Julie Jackson & Jane Forrest

You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Eleanor McFadden .

Editor information

Editors and affiliations.

Samuel Oschin Comprehensive Cancer Insti, WEST HOLLYWOOD, CA, USA

Steven Piantadosi

Bloomberg School of Public Health, Johns Hopkins Center for Clinical Trials Bloomberg School of Public Health, Baltimore, MD, USA

Curtis L. Meinert

Section Editor information

Frontier Science (Scotland) Ltd, Kincraig, UK

Eleanor McFadden

Rights and permissions

Reprints and permissions

Copyright information

About this entry

Cite this entry.

McFadden, E., Jackson, J., Forrest, J. (2020). Documentation: Essential Documents and Standard Operating Procedures. In: Piantadosi, S., Meinert, C. (eds) Principles and Practice of Clinical Trials. Springer, Cham. https://doi.org/10.1007/978-3-319-52677-5_45-1

Download citation

DOI : https://doi.org/10.1007/978-3-319-52677-5_45-1

Received : 08 January 2019

Accepted : 10 October 2019

Published : 08 November 2019

Publisher Name : Springer, Cham

Print ISBN : 978-3-319-52677-5

Online ISBN : 978-3-319-52677-5

eBook Packages : Springer Reference Mathematics Reference Module Computer Science and Engineering

Publish with us

Policies and ethics

Find a journal
Track your research

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.

This website uses cookies to ensure you get the best experience. Learn more about DOAJ’s privacy policy.

Hide this message

You are using an outdated browser. Please upgrade your browser to improve your experience and security.

The Directory of Open Access Journals

Quick search.

Perspectives in Clinical Research (Jan 2011)

Good documentation practice in clinical research

Chitra Bargaje

Affiliations

Read online

documentation

WeChat QR code

DOI: 10.4103/2229-3485.80368
Corpus ID: 7097983

Good documentation practice in clinical research

Chitra Bargaje
Published in Perspectives in Clinical… 1 April 2011

41 Citations

How to document a clinical study and avoid common mistakes in study conduct, assessing data quality and the variability of source data verification auditing methods in clinical research settings, a comparative study to evaluate quality of data documentation between investigator-initiated and pharmaceutical industry-sponsored studies, good financial practice and clinical research coordinator responsibilities., integration of clinical research documentation in electronic health records., quality and completeness of data documentation in an investigator-initiated trial versus an industry-sponsored trial., plagiarism: pre-submission screening.

Highly Influenced

Processes and Practices Improvement of Sample Receiving Counter at Government Clinical Laboratory in Sri Lanka

Health professionals’ routine practice documentation and its associated factors in a resource-limited setting: a cross-sectional study, perianesthesia nurses pain management practices: findings and recommendations from a national descriptive study of members of the american society of perianesthesia nurses., 3 references, related papers.

Showing 1 through 3 of 0 Related Papers

Get new issue alerts Get alerts
Submit a Manuscript

Secondary Logo

Journal logo.

Colleague's E-mail is Invalid

Your message has been successfully sent to your colleague.

Save my selection

Good documentation practice in clinical research

Bargaje, Chitra

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

Address for correspondence: Dr. Chitra Bargaje, Bristol-Myers Squibb Co., 1 st floor, Shivsagar Estate, AB Road, Worli, Mumbai-400018, India. E-mail: [email protected]

This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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:

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.

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.

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.

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.

ALCOA; documentation; source; training

+ Favorites
View in Gallery

Readers Of this Article Also Read

A comparative study to evaluate quality of data documentation between..., development of medical writing in india: past, present and future, human subject protection in india – is it adequate.

Europe PMC requires Javascript to function effectively.

Either your web browser doesn't support Javascript or it is currently turned off. In the latter case, please turn on Javascript support in your web browser and reload this page.

Online GMP Courses with Certificate

Quality Assurance

Requirements for Good Documentation Practice (GDP)

today = new Date() if ((today.getHours() >=9) && (today.getHours() today = new Date() if ((today.getHours() >=18) && (today.getHours() =0) && (today.getHours() .reverse { unicode-bidi: bidi-override; direction: rtl; display:none;} Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of pharmaguideline.com, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips. .moc.enilediugamrahp@ofni :liamE Need Help: Ask Question

12 comments: Post Yours! Read Comment Policy ▼ PLEASE NOTE: Comments shall be published after review. Spams/ Promotional links are not allowed and shall be deleted upon review. You can ask questions related to this post here.

What about the digitalization of SOPs and records following a ZERO PAPER policy? In case we generate records only with an IT system is it mandatory to keep the raw data if we keep a scanned copy?

Nice share...

Is there any GDP policy regarding the register, logbook etc. can we use spiral binding log books and registers for data recording?

Spiral binding logbook is not a good option and auditor will not allow its pages can be changed easily.

In case of hand written document like ROA, if some of the details are same like reagent preparation or chemical details. is it allowed to fill it in one document and the other document has its reference no. only?

If your using same chemical on the same day it is ok.

Dear Sir, We are using different logbooks but some have only "done by" option or only "checked by" option and some have both options. It's confusing. Is it required to have both "done by" and "checked by" option in Logbook?

Yes both are required.

Is there any reference for not to use spiral binding or any observation latter on it?

Anything less than four-eye principle is a violation of GMP.

Thank you sor

If I had multiple printouts (data), all associated with one particular test - each page automatically states Page 1 of 1 - is it possible to staple all the associated pages together (treated now as one document/attachment), sign the front page as the person it was performed by and pagerise the remaining pages?

Please don't spam. Comments having links would not be published.

Popular Categories

Jobs

Follow Pharmaguideline

Like	Follow
Follow	Follow
Follow	Install
Join

PHARMACEUTICAL DOCUMENTS

Editable Pharmaceutical Documents in MS-Word Format. Ready to use SOPs, Protocols, Master Plans, Manuals and more...

Discussion - Latest Topics

Advertise here, get app for news updates.

Pharmaceutical Updates

✔ Worldwide Regulatory Updates ✔ Pharmaceutical News Updates ✔ Interview Questions and Answers ✔ All Guidelines in One Place

Health professionals’ routine practice documentation and its associated factors in a resource-limited setting: a cross-sectional study

Addisalem workie demsash.

1 College of Health Science, Health Informatics Department, Mettu University, Mettu, Ethiopia

Sisay Yitayih Kassie

Abiy tasew dubale, alex ayenew chereka, habtamu setegn ngusie.

2 College of Health Science, Health Informatics Department, Woldia University, Woldia, Ethiopia

Mekonnen Kenate Hunde

3 College of Education and Behavioral Science, Lifelong Learning and Community Development Department, Mettu University, Mettu, Ethiopia

Milkias Dugassa Emanu

4 College of Health Science, Nursing Department, Mettu University, Mettu, Ethiopia

Adamu Ambachew Shibabaw

Agmasie damtew walle, associated data.

All the data generated and analysed during this study are included, in the table and text form, in this article. If required, the data will be available on request from the corresponding author. Not applicable.

Documenting routine practice is significant for better diagnosis, treatment, continuity of care and medicolegal issues. However, health professionals’ routine practice documentation is poorly practised. Therefore, this study aimed to assess health professionals’ routine practice documentation and associated factors in a resource-limited setting.

An institution-based cross-sectional study design was used from 24 March up to 19 April 2022. Stratified random sampling and a pretested self-administered questionnaire were used among 423 samples. Epi Info V.7.1 and STATA V.15 software were used for data entry and analysis, respectively. Descriptive statistics and a logistic regression model were employed to describe the study subjects and to measure the strength of association between dependent and independent variables, respectively. A variable with a p value of <0.2 in bivariate logistic regression was considered for multivariable logistic regression. In multivariable logistic regression, ORs with 95% CIs and a p value of <0.05 were considered to determine the strength of association between dependent and independent variables.

Health professionals’ documentation practice was 51.1% (95% CI: 48.64 to 53.1). Lack of motivation (adjusted OR (AOR): 0.41, 95% CI: 0.22 to 0.76), good knowledge (AOR: 1.35, 95% CI: 0.72 to 2.97), taking training (AOR: 4.18, 95% CI: 2.99 to 8.28), using electronic systems (AOR: 2.19, 95% CI: 1.36 to 3.28), availability of standard documentation tools (AOR: 2.45, 95% CI: 1.35 to 4.43) were statistically associated factors.

Conclusions

Health professionals’ documentation practice is good. Lack of motivation, good knowledge, taking training, using electronic systems and the availability of documentation tools were significant factors. Stakeholders should provide additional training, and encourage professionals to use an electronic system for documentation practices.

WHAT IS ALREADY KNOWN ON THIS TOPIC

Although routine practice documentation is a legal obligation and crucial for the continuity of patient care, health professionals’ documentation practices are poor, contain errors that further affect patient outcomes and create distorted health information.

WHAT THIS STUDY ADDS

This study assesses routine practice documentation in resource-limited setting including all types of health professionals, and identify associated factors.
Additionally, whether health professionals’ documentation of education and counselling they give to patients and use an electronic system was assessed.

HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY

This study is crucial for health policy formulators, planners and implementers to enhance health professionals’ motivation for better documentation practice.
This study may motivate health professionals to use an electronic system for documentation practice as much as possible.
The evidence would serve as input for future similar studies.

Introduction

In routine healthcare practice, evidence about the care and treatment of patients, progress notes, assessments and care plans, 1 laboratory tests and results, medication and drug prescription information, patient education and counselling 2 are some of the routine practices of health professionals. Therefore, documenting the health professionals’ routine practices are important for various purposes.

Documentation is a standard way of keeping ongoing patient care information. It is the relevant facts of routine health information and patient care plans, 3 such as professionals’ evaluation and judgement about the patients, evaluation charts, tests, reports, subjective notes or professionals’ reflections. 4

Documenting routine practices is essential for the continuity of patient care, legal defence, reimbursement, communication among healthcare professionals and better patient diagnoses and treatments. 5 Maintaining routine practice is part of the health professional obligation. Healthcare facilities’ by-laws or policies should require health professionals to complete patient records. 6 Whether the documentation is a paper-based or electronic system, it should be patient-focused, accurate, relevant, clear, permanent, confidential and timely. Electronic patient record systems are better for reducing the time spent on documenting patient information and enhancing the quality of documentation. 7

Poor documentation practice affects patient management, continuity of patient care and medicolegal issues, which arise from incomplete and inadequate documentation, lack of accuracy and poor quality. 8 It leads to adverse patient outcomes, medication errors and patient deaths. 9 Distorted health information may influence health professionals’ decision-making capabilities due to inappropriate and misleading documentation practices. 10

Globally, poor communication between health professionals is a reason for medical error and patient mortality. 9 Many health professionals’ documentation practice is incomplete, inaccurate and of poor quality. According to evidence from the USA, documentation errors are a cause of at least one death and 1.3 million injuries annually. 11 Moreover, health professionals’ documentation practice is inadequate such as 33.3% in Indonesia, 12 47% in England 13 and 50% in Iran. 14

In the low-income and middle-income regions, a qualitative study undertaken in Uganda stated that documentation practice is limited by constraints and poor support from the administration. 15 In Ghana, 46% of care is provided, and progress notes are not documented after the first day of patient admission. 16 In Nigeria, only 44% of health professionals had good documentation knowledge and practice. 17

In Ethiopia, documentation is poorly practised and has been reported as being left undone. 3 Health professionals’ documentation practice is 47.8% in the Tigray 18 and 37.4% 3 in Amhara regions. Surprisingly, 88% of the medication provided has been wrongly documented. 19 A study report in the Amhara region states that 87% of the medications had documentation errors. 19

Age, sex, experience, income, levels of education, health professionals’ knowledge and attitude, 3 12 18 motivation, workload and training about documentation 20 are factors associated with routine practice documentation.

Documenting health professionals’ routine activities is valuable for sharing knowledge and learning from history. This has a significant impact on better decision-making and accuracy in patient diagnosis and treatment. As per our literature review, studies have not been undertaken in the current study setting. Few studies in similar settings have been carried out with only nursing as a study participants, education and counselling given to the patient were not assessed. So, assessment documentation practice in both medical and non-medical practices, including all health professionals is crucial. Therefore, this study aimed to determine health professionals’ routine practice documentation and associated factors.

Study design and period

An institutional-based cross-sectional study design was employed among health professionals working in public health facilities in the Ilu Aba bora Zone, from 24 March up to 19 April 2022.

Study setting

Ilu Aba Bora Zone is found in Southwest Ethiopia. The zone is located 600 km away from Addis Ababa, the capital city of Ethiopia. In the zone, there are 44 total health facilities and 2 hospitals (1 general hospital and 1 referral hospital). The public health facilities provide different health services for more than a million of the population in southwest parts of the country coming from Gambela, Southern Nation Nationality and People’s region.

Study population and eligibility criteria

All healthcare professionals working in the public health facilities of Ilu Aba Bora Zone and those who were found during the data collection period were the sources and study population, respectively. Healthcare professionals who were not permanently employed, those who were not present during the study period and who worked as data clerks were excluded.

Sampling size determination

A sample size (n) was determined by using a single population proportion formula, N=(Z a/2 ) 2 ×P(1−P)/d 2 , where n=the required sample size, (Za /2 ) 2 =the value of standard normal distribution or 1.96, p=the prevalence of documentation practice among health professionals and so the default maximum value of 50% was used for P, d=degree of precision or 0.05. Taking this, the required sample size was calculated to be 384. After adding a 10% non-response rate, a total of 423 healthcare professionals participated in this study.

Sampling producer

A stratified simple random sampling method was used. Due to the limited resources, we have to cover all types of health facilities, we have included two hospitals directly and three randomly selected health centres. Once the sample was stratified based on the types of randomly selected health facilities, the sample was allocated to each stratum proportionally. Then, a simple random sampling technique was used to select the study subjects in each public health facility. The list of health professionals was taken from human resource departments. Accordingly, there are 1043 health professionals from 5 randomly selected health facilities. The sampling procedure has been presented in figure 1 .

An external file that holds a picture, illustration, etc.
Object name is bmjhci-2022-100699f01.jpg

Sampling procedures of study participant selection. HC, health centres.

Operationalisations and measurements

In the healthcare system, patient status, medical diagnoses, planned care, medical interventions or treatments, laboratory tests, result confirmations, medications, patient education and counselling, communication and delivering service are activities of health professionals. All the mentioned activities of health professionals are either medical or non-medical activities (patient education and counselling), but all are routine activities for health professionals. As a result, health professionals use standard documentation tools such as manual records and/or electronic systems to document their routine activities correctly and on time while respecting the rules of ethics. 21 Accordingly, health professionals’ routine practice documentation was assessed by using 12 ‘yes’ and ‘no’ questions. 3 22 The level of health professionals’ routine practice documentation was determined using the mean value as a cut-off point. Hence, the level of health professionals’ routine practice documentation is good if the score is above or equal to the mean value, and otherwise poor documentation practice.

The study participants’ level of knowledge was measured by using 10 ‘yes’ and ‘no’ options. Health professionals who scored above or equal to the mean score were considered to have good knowledge, and those who scored below the mean value had poor knowledge. 3

The study participants’ level of attitude was measured by using nine Likert scale questions with responses ranging from 1 ‘strongly agree’ to 5 ‘strongly disagree’. 3 18 Health professionals who scored above or equal to the mean score were considered to have a good attitude, otherwise, poor attitude.

Data collection tool and quality assurance

The tool used was developed based on reviewing similar studies. 3 18 22 A pretested, self-administered questionnaire was used. Two supervisors and three data collectors received 2 days of intensive training on the study objectives and how to approach study participants. A pretest was done outside the study area with 10% of the study subjects to check the readability and consistency of the questionnaire. The data obtained from the pretest were used to check the validity and reliability of the tool. The Cronbach’s alpha was used to check the reliability of the tool with a value of 83.

Data processing and analysis

The data entry was performed using Epi Info V.7.1 software packages and analysed using STATA V.15 software. Descriptive statistics were computed to describe the sociodemographic characteristics of the healthcare professionals, their knowledge and their attitudes towards routine practice documentation. Bivariable and multivariable binary logistic regression analyses were conducted to measure the association between the dependent and independent variables. In the bivariable regression analysis, variables with a p value of <0.2 were considered for further multivariable logistic regression analysis. The OR with a 95% CI level was assumed to assess the strength of the association between dependent and predictor variables. For all significantly associated variables, a p value <0.05 was used as a cut-off point. A variance inflation factor was performed. Consequently, its value for all predictors was between one and three. This revealed that there was no correlation between the variables. The Hosmer-Lemeshow test was performed to assess the model fitness, and so model was fitted (p=0.271).

Description of study subjects

From 423 participants, 415 responded to a questionnaire with a 98.11% response rate. The mean age of the study subjects was 29.28 (SD±2.21) years with a minimum age of 21 years and a maximum age of 59 years. Half (51.1%) of the study subjects were male. The majority (66.7%) of study subjects were BSc degree holders or below. Of the total respondents, around 6–10 (62.4%) of the study participants had up to 5 years of working experience.

Less than half (32.3%) of the study subjects were trained in routine practice documentation. Of 415 study participants, 235 (56.6%) health professionals earned 4500–7500 Ethiopian Birr per month, and 8–10 (80.2%) health professionals responded that standard documentation tools were available in the working area. One hundred twenty-five (54.22%) health professionals used manual forms for documentation purposes ( table 1 ).

Sociodemographic characteristics of health professionals

Sociodemographic characteristics	Frequency	Per cent
Sex
Female	199	48.0
Male	216	52.0
Educational status
Degree and below	277	66.7
Master and above	138	33.3
Age (in years)
21–25	65	15.7
26–30	244	58.8
31–35	59	14.2
>35	47	11.3
Month salary (Ethiopian Birr)
Up to 4500	93	22.4
Between 4500 and 7500	235	56.6
>7500	87	21.0
Experience (in years)
1–5 years	259	62.4
Between 6 and 10 years	88	21.2
>10 years	68	16.4
Training for standard documentation tools
Yes	134	32.3
No	281	67.7
Availability of standard documentation tools
Yes	333	80.2
No	82	19.8
Types of documentation tools used
Electronic system	190	45.78
Manual form	225	54.22

Health professionals’ routine practice documentation

Overall, 51.1% (95% CI: 46.29% to 53.55%) of health professionals had good routine practice documentation; 6.99% of different laboratory test request forms were not completed and documented; 6.025% of the physicians’ prediagnosis was completed and documented; 5.54% of drug prescription and laboratory result forms were not completed and documented. Documentation incompleteness accounted for 32.52% of health professionals’ poor routine practice documentation ( table 2 ).

Checklists examine health professionals’ routine practice documentation adopted from the Ethiopian health institution reform implementation guidelines

Sn	Content of items for routine practice documentation	Yes (%)	No (%)
1	Patients’ admission assessment is documented or attached for the patient admitted	17 (4.10)	13 (3.13)
2	Physicians’ prediagnosis is completed and documented	14 (3.37)	25 (6.02)
3	Different laboratory test request forms completed and documented	19 (4.58)	29 (6.99)
3	The nursing care plan is completed and attached to the patient’s card	28 (6.75)	15 (3.61)
4	Laboratory request accepted and attached to patient card	21 (5.06)	14 (3.37)
5	Laboratory results from filling out (completed) and documented	15 (3.61)	23 (5.54)
6	Laboratory results attached to patient cards	12 (2.90)	11 (2.65)
7	Final diagnosis and treatment results documented	10 (2.41)	24 (5.78)
9	Drug prescription forms completed and documented	20 (4.82)	23 (5.54)
10	Maternal and child health service forms completed and documented	22 (5.30)	12 (2.89)
11	Follow-up form (form for chronic patients) completed and documented	18 (4.34)	8 (1.93)
12	Progress report documented including education and counselling given to the patients	16 (3.86)	6 (1.45)
	Overall health professionals’ routine practice documentation	212 (51.1)	203 (48.9)

Factors associated with routine practice documentation

Bivariate and multivariate logistic regressions were used to measure the association between dependent and independent predictors. In the bivariate logistic regression, p<0.2 was used and sex, age, training, knowledge, attitude, types of documentation tools, availability of standard documentation tools, workload and motivation of study subjects were the candidate variables for the multivariable regression analysis. In the multivariable regression model, knowledge, training, motivation, types and availability of the standard documentation tools were significant factors for routine practice documentation ( table 3 ).

Bivariate and multivariate analysis of factors associated with health professionals’ routine practice documentation (n=415)

Variables	Routine practice documentation				OR (95% CI)
	Poor practice		Good practice		COR (95% CI)	AOR (95% CI)
	n	%	n	%
Sex
Male	107	25.80	103	24.80	0.95 (0.65 to 1.40)*	0.93 (0.60 to 1.44)
Female	96	23.10	109	26.30	1	1
Knowledge
Good	123	29.64	148	35.66	1.50 (1.00 to 2.26)*	1.35 (0.72 to 2.97)†
Poor	80	19.28	64	15.42	1	1
Age (in years)
26–30	120	28.92	124	29.88	0.83 (0.48 to 1.44)*	1.10 (0.58 to 2.08)
31–35	23	5.54	36	8.67	1.26 (0.62 to 2.58)	1.20 (0.52 to 2.77)
>35	31	7.47	16	3.86	0.42 (0.19 to 0.90)	0.51 (0.21 to 1.34)
21–25	29	6.99	36	8.67	1	1
Motivation
No	171	41.21	163	39.28	0.62 (0.38 to 1.02)*	0.41 (0.22 to 0.76)†
Yes	32	7.71	49	11.80	1	1
Attitude
Good	165	39.76	182	43.86	1.40 (0.83 to 2.36)*	1.09 (0.71 to 2.04)
Poor	38	9.15	30	7.23	1	1
Training on documentation
Yes	32	7.71	102	24.57	4.96 (3.12 to 7.88)*	4.18 (2.99 to 8.28)†
No	171	41.21	110	26.51	1	1
Availability of documentation sheet
Yes	147	35.42	186	44.82	2.73 (1.63 to 4.55)*	2.45 (1.35 to 4.43)†
No	56	13.50	26	6.26	1	1
Types of tool used for documentation
Electronic system	119	28.67	80	19.28	2.34 (1.58 to 3.47)*	2.19 (1.36 to 3.28)†
Manual form	84	20.24	132	31.81	1	1
Workload
Yes	130	31.33	151	36.39	0.67 (0.33 to 1.36)*	0.48 (0.21 to 1.10)
No	64	15.42	70	16.86	1	1

Reference category=1.

*Significant in COR.

†Significant in AOR.

AOR, adjusted OR; COR, crude OR.

Health professionals who lack motivation were 59% (adjusted OR (AOR): 0.41, 95% CI: 0.22 to 0.76) less likely to document routine practices. Health professionals who had good knowledge of routine practice documentation were 1.4 (AOR: 1.35, 95% CI: 0.72 to 2.97) times more likely to document routine practice than those who had poor knowledge. Health professionals who were trained in routine practice documentation were 4.2 (AOR: 4.18, 95% CI: 2.99 to 8.28) times more likely to document routine practices than those who were not trained. Health professionals who used electronic systems for routine practice documentation were 2.2 (AOR: 2.19, 95% CI: 1.36 to 3.28) times more likely to document their routine practices than those who used manual forms for documentation. The availability of standard documentation tools were 2.5 (AOR: 2.45, 95% CI: 1.35 to 4.43) times more odds for health professionals to document their routine practices ( table 3 ).

This study assesses health professionals’ routine practice documentation and associated factors. Health professionals who had good knowledge about routine practice documentation, training on documentation, using electronic systems for documentation, the availability of standard documentation tools and a lack of motivation towards routine practice documentation were statistically significant factors associated with health professionals’ routine practice documentation.

The study revealed that health professionals’ routine practice documentation was good (51.1%). This finding is higher than previous similar studies, which found 44.2% in Nigeria, 17 33.3% in Indonesia 12 and 37.4%–48.8% in different parts of Ethiopia. 3 18 23 However, the finding is lower than the study done in Jamaica, which reports that health professionals’ documentation practice is 98%. 24 This might be due to the utilisation of technologies such as the electronic medical record and district health information system V.2 (DHIS2), the accessibility of required tools for documentation and health professionals’ good commitment to using DHIS2 data. 19 Additionally, this variation might be due to the information difference, the time gap between studies, the high patient flow, the shortage of time and the workload of health professionals.

Health professionals who lack motivation were 59% less likely to have documentation practices when compared with those who had gained motivation. This finding is inconsistence with studies done in Ethiopia. 23 25 This might be poor professional encouragement, poor financial support, less opportunities for further educational development, poor infrastructures and low hospital management support. 25

Health professionals for whom standard documentation tools were available were 2.5 times more likely to document routine practices than those for whom standard documentation tools were not available. This finding is consistence with a study done in Australia, 26 Tigray 18 and Amhara regions. 23 This might be due to familiarisation with standard documentation sheets, and the accessibility of integrated routine health information forms for recording and reporting. 27

Health professionals who had good knowledge of routine practice documentation were more likely to document their routine practice. This result is supported by studies done in Ethiopia, 3 the USA 28 and Australia. 29 This might be due to health professionals’ familiarity with documentation guidelines and manual forms that improve health professionals’ knowledge of routine practice documentation. 3 Additionally, the reason might be that health professionals understand the importance of documenting routine practice, the viability of reading materials, know that record-keeping is required for medicolegal issues and have good competency in the area of documentation. 29 Moreover, spending on documentation courses may promote health professionals’ knowledge. 30

Health professionals who were trained in routine practice documentation were 4.2 times more likely to document routine practices than those who were not trained. This evidence is supported by studies done in Ethiopia 3 and Iran. 30 This might be due to training, which might enhance health professionals’ knowledge and motivation for documentation and provide team-based learning, intrapersonal skills sharing and consultation gained from colleagues. Plus, training may force health professionals to develop a positive attitude towards routine practice documentation. 3

Health professionals who used electronic systems for routine practice documentation were 2.2 times more likely to document their routine practices than those who used manual forms. This study is supported by a study done in Ethiopia 20 and a study done about maintaining practices and record-keeping. 1 This might be due to the capability of electronic systems to reduce the time spent documenting patient care. 7 Additionally, record-keeping in the light of recent public inquiries, national interests in shifting from paper to digital storage of data, the capability of electronic health records to generate a complete record of an episode of care and the longitudinal nature of the electronic system might be possible reasons. 1 Moreover, a need for real-time access to health information when and where it is needed might be reason why an electronic system could be more likely to be good for documentation. 23

Strength and limitation

Since the data were collected at a specific time, social desirability bias may occur. Significant variables may have a temporal relationship. This study assesses the use of electronic systems for documentation as an independent variable. All health professionals were included, and documentation regarding education and counselling was assessed. Hence, the finding is unique as compared with previous studies. Moreover, the mean value was used as a cut-off point to determine level of health professionals’ routine practice documentation to consider the weighted average values.

In this study, health professionals have good routine practice documentation. Knowledge, training, using an electronic system, availability of standard documentation tools and lack of motivation are statistically significant factors for routine practice documentation. Health policy formulators and stakeholders give additional training to health professionals, and encourage them to use an electronic system for documentation. Stakeholders should improve health professionals’ knowledge and motivation of routine practice documentation. Additional high-quality studies are required on a similar topic.

Contributors: AWD had made a substantial contribution in writing the conception, designing the study, analyzing the data, and discussing the findings. SYK and ATD were involved in drafting the manuscript and interpreting the results. AAC and HSN had revised the manuscript. MKH, AAS, ADW, and MDE all made significant contributions to revising the manuscript, and managing the data. All authors read and approved the final manuscript submission for publication.

Funding: The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

Competing interests: None declared.

Provenance and peer review: Not commissioned; externally peer reviewed.

Data availability statement

Ethics statements, patient consent for publication.

Not applicable.

Ethics approval

Ethics approval was obtained from the Institutional Review Committee of the health science college of Mettu University with reference number ARcsu/271/24. Informed verbal and written consent from the study participant was obtained.

IMAGES

Good Documentation Practice in Clinical Research
Good Documentation Practices for NIMHSponsored Studies Clinical Research
(PDF) Good documentation practice in clinical research
Good Documentation Practices for NIMHSponsored Studies Clinical Research
LMK Webinar Series Part 2 Good Clinical Documentation Practices
BEST BASIC GOOD DOCUMENTATION PRACTICES

VIDEO

GMP Detox GDP = Good Documentation Practices?
Good Documentation Practices (GDP)
How Documentation Impacts Pathology Reimbursements & Coding
Good documentation practices "GDP" and GMP , definition, importance, principles مبادئ التوثيق الجيد
BEST BASIC GOOD DOCUMENTATION PRACTICES
GOOD DOCUMENTATION PRACTICES (GDP) OR (GDocP) ALCOA , ALCOA+,ALCOA++

COMMENTS

Good documentation practice in clinical research
Good documentation practice in clinical research - PMC
(PDF) Good documentation practice in clinical research
Additionally, good documentation practices in source documentation are an essential part of a well-run clinical trial. Source documents are medical records providing documentation prior to, during ...
PDF ALCOA + C Clinical Research Good Documentation
Clinical Research Good Documentation Practices ALCOA ...
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 ...
ICH Guidance Documents
ICH Guidance Documents
Handbook for Good Clinical Research Practice (Gcp)
Good Clinical Research Practice (GCP) is a process that incorporates established ethical and scientiﬁ c quality standards for the design, ... ating valid observations and sound documentation of the ﬁ ndings, GCP not only serves the interests of the parties actively involved in the research process, but also protects the rights, safety and ...
Documentation: Essential Documents and Standard Operating ...
The version of ICH E6 Guidelines on Good Clinical Practice (GCP) published in November 2016 defines Documentation as "All records in any form (including, but not limited to, written, electronic, magnetic, and optical records, and scans, x-rays, and electrocardiograms) that describe or record the methods, conduct, and/or results of a trial, the factors affecting a trial, and the actions taken."
PDF ICH-E6 Good Clinical Practice (GCP)
ICH-E6 Good Clinical Practice (GCP)
Students' guide to documentation in clinical trials
Documentation in clinical trials adheres to the principles of Good Clinical Practice (GCP), and healthcare professionals involved in the conduct of clinical trials—including students—are obliged to perform documentation in accordance with GCP principles. Unprecedented challenges have arisen with regard to the appropriate training of ...
Good Clinical Practice Study Documentation
Good Clinical Practice Study Documentation
Good Documentation Practices for Clinical Research
Good Documentation Practices Adherence to best practice methods in the conduct of clinical research provides assurance that … Human subjects' rights, well being and privacy will be protected Data will be accurate and credible Methods and findings can be verified by sponsors and regulators (efficiently)
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. One of the most common inspection findings in ...
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 focuses on the key principles of good documentation practice and offers suggestions for improvement [1]. Inadequate/misguided case histories shape the ...
PDF Research Good Documentation Practices
Research Good Documentation Practices. 't happen"ALCOA+C =AttributableIt should be obvious who documented or did what; traceable to a person, date, t. me, and participant visit or contact. The document should also show who made any. nd the reason for the change.LegibleThe record should be easy to read with identifiable signatures (if not, a ...
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. 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 ...
Good documentation practice in clinical research.
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.
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. ... Clinical research documentation involves a ...
Good documentation practice
Good documentation practice
The Impact of Structured and Standardized Documentation on
The Impact of Structured and Standardized Documentation ...
Good documentation practice in clinical research.
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.
Requirements for Good Documentation Practice (GDP)
Requirements for Good Documentation Practice (GDP)
Health professionals' routine practice documentation and its associated
Health professionals' routine practice documentation and ...
Good Documentation Practices (GDP) in Clinical Research & Pharma
Here we explore the exciting Good documentation practices (DGP) in clinical research and Pharma industry and explain the standards, guidelines and what are c...

Good documentation practice in clinical research

Save citation to file

Add to My Bibliography

Good documentation practice in clinical research

Similar articles

Related information

LinkOut - more resources

U.S. Food and Drug Administration

ICH Guidance Documents

Documentation: Essential Documents and Standard Operating Procedures

Access this chapter

Similar content being viewed by others

Data Capture, Data Management, and Quality Control; Single Versus Multicenter Trials

How to Maintain Excellent Clinical Documentation

Author information

Corresponding author

Editor information

Section Editor information

Rights and permissions

Copyright information

About this entry

Download citation

Good Clinical Practice Study Documentation

General Information

Note to File

Informed Consent

Case Report Forms as Source

Medical Records From Outside Source

Questionnaires

The Directory of Open Access Journals

Good documentation practice in clinical research

WeChat QR code

Good documentation practice in clinical research

41 Citations

Processes and Practices Improvement of Sample Receiving Counter at Government Clinical Laboratory in Sri Lanka

Secondary Logo

Good documentation practice in clinical research

INTRODUCTION

WHAT IS THE PURPOSE OF SOURCE DOCUMENTATION?

PRINCIPLES OF GOOD DOCUMENTATION PRACTICE

ICH E6 1.51 source data

ICH E6 1.52 source documents

Attributable

Contemporaneous

Available and accessible

Corroborated

COMMON FINDINGS WITH RESPECT TO SOURCE DOCUMENTATION

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

HOW CAN THE DOCUMENTATION BE IMPROVED?

CONCLUSIONS

Readers Of this Article Also Read

Requirements for Good Documentation Practice (GDP)

12 comments: Post Yours! Read Comment Policy ▼ PLEASE NOTE: Comments shall be published after review. Spams/ Promotional links are not allowed and shall be deleted upon review. You can ask questions related to this post here.

Popular Categories

Follow Pharmaguideline

Discussion - Latest Topics

Recent Posts

Health professionals’ routine practice documentation and its associated factors in a resource-limited setting: a cross-sectional study

Sisay Yitayih Kassie

Mekonnen Kenate Hunde

Milkias Dugassa Emanu

Adamu Ambachew Shibabaw

Conclusions

WHAT IS ALREADY KNOWN ON THIS TOPIC

WHAT THIS STUDY ADDS

HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY

Introduction

Study design and period

Study setting

Study population and eligibility criteria

Sampling size determination

Sampling producer

Operationalisations and measurements

Data collection tool and quality assurance

Data processing and analysis

Description of study subjects

Health professionals’ routine practice documentation

Factors associated with routine practice documentation

Strength and limitation

Data availability statement