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
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2. CONTENTS
 Principles
 Essential Documents
 Examples of GDP
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3. PRINCIPLE OF GDP
Attributable Legible
Contemporaneous Original
Accurate
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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
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5. EXAMPLES OF GDP (1/8)
 Overwrite
 Principal followed : Accurate
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6. EXAMPLES OF GDP (2/8)
 Traceable
Principle followed : Legible
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7. EXAMPLES OF GDP (3/8)
o 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)
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8. EXAMPLES OF GDP (4/8)
 Followed by: original
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9. EXAMPLES OF GDP (5/8)
 Principle followed : Attributable
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10. EXAMPLES OF GDP (6/8)
 Principle followed : Contemporaneous
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11. EXAMPLES OF GDP (7/8)
 Backdate
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12. EXAMPLES OF GDP (8/8)
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 Principle followed : Accurate
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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
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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
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15. Thank You
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