Good Documentation Practices Examples in Clinical Trials I Clinical Research.pptx

What are Good Documentation Practices?
In the context of these guidelines, good documentation practices are those measures that collectively and individually ensure documentation, whether paper or electronic, is secure, attributable, legible, traceable, permanent, contemporaneously recorded, original and accurate.
Inform Consent form
Investigator’s brochure
Case report form
Clinical study protocol
Clinical study reports
Trial master file
Laboratory reports
Standard operating procedure

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.
Apply the ALCOA acronym for proper technique of documentation:
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.

Standards

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.

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.

Siro Clinical Research Institute. www.siroinstitute.com
Post Graduate Diploma in Clinical Research. Pharmacovigilance, Clinical Trials, Clinical Data Management, Clinical Operation, Medical writing.

1. Good Documentation practices- Examples presented by- Akshata chandak Sonal takarkhede Payal gade 1 SIRO Clinical Research Institute www.siroinstitute.com

2. Contents Principles Essential Documents Examples of GDP 2 SIRO Clinical Research Institute www.siroinstitute.com

3. Principle of GDP 3 SIRO Clinical Research Institute www.siroinstitute.com

4. Essential documents Inform Consent form Investigator’s brochure Case report form Clinical study protocol Clinical study reports Trial master file Laboratory reports Standard operating procedure 4 SIRO Clinical Research Institute www.siroinstitute.com

5. Examples of GDP (1/8) Overwrite Principal followed : Accurate 5 SIRO Clinical Research Institute www.siroinstitute.com

6. Examples of GDP (2/8) Traceable Principle followed : Legible 6 SIRO Clinical Research Institute www.siroinstitute.com

7. Examples of GDP (3/8) Followed by: Contemporaneous Follow date and time format as per SOP Date Format Time Format DD/MM/YYYY 00:00 to 23:00 hours OR OR DD/MM/YY 12 am to 12 pm OR OR MM/DD/YYYY (HH:MM:SS, PM/AM) 7 SIRO Clinical Research Institute www.siroinstitute.com

8. Examples of GDP (4/8) Followed by: original 8 SIRO Clinical Research Institute www.siroinstitute.com

9. Examples of GDP (5/8) Principle followed : Attributable 9 SIRO Clinical Research Institute www.siroinstitute.com

10. Examples of GDP (6/8) Principle followed : Contemporaneous 10 SIRO Clinical Research Institute www.siroinstitute.com

11. Examples of GDP (7/8) Backdate 11 SIRO Clinical Research Institute www.siroinstitute.com

12. Examples of GDP (8/8) 12 Principle followed : Accurate SIRO Clinical Research Institute www.siroinstitute.com

13. do’s Do record data as soon as it is generated Do take ownership of data you’ve recorded Do validate your computerized system or document software Do specify when data was recorded, reviewed, and approved Do backup data, either automatically or by storing the true copy in a separate location 13 SIRO Clinical Research Institute www.siroinstitute.com

14. Don’ts Don’t delay data recording Don’t sign for someone else, even if asked Don’t intentionally falsify data Don’t self -verify data you’ve recorded Don’t pre- date or back-date 14 SIRO Clinical Research Institute www.siroinstitute.com

15. Thank You 15 SIRO Clinical Research Institute www.siroinstitute.com