MCQs on Good Documentation Practice

By | January 2, 2024

1. According to GCP, source documents should be:
A) Stored securely for required retention period
B) Amended using a single line-through method
C) Original documents completed during trial
D) All of the above

2. Corrections to source documents should include which elements according to GCP?
A) Initials and date of person making correction
B) Explanation for correction
C) Original entry history
D) All of the above

3. According to GCP, how should records containing adverse event information be documented?
A) In patient’s medical history
B) In source documents and CRFs
C) Verbatim in investigator notes
D) As summary in sponsor reports

4. What type of documentation verifes data listed on CRFs according to GCP?
A) Source documents
B) Data clarification forms
C) Signature logs
D) Delegation of authority records

5. According to GCP, how must trial documentation authenticate participant identity?
A) Full name and date of birth
B) Unique trial identification number
C) Initials or alternative ID code
D) Signature or fingerprint

6. What individual according to GCP verifies accuracy of data transcription between source and CRF?
A) Data manager
B) Medical writer
C) Clinical monitor
D) Statistician

7. When documenting informed consent discussions, GCP guidelines state the process must be documented:
A) Using checklist
B) In source or patient medical notes
C) Verbatim in protocol
D) Both A and B

8. According to GCP, how should the date format be standardized for trial documentation?
D) No standard format required

9. What document according to GCP defines data handling standards and procedures?
A) Data management plan
B) Records retention SOP
C) Data validation manual
D) All of the above

10. When must documentation of eligibility screening be completed according to GCP?
A) Before randomization
B) Prior to enrollment
C) Within 30 days of consent
D) Not specified in guidelines

11. Which process according to GCP verifies accuracy of clinical data collection?
A) Data clarity
B) Source data verification
C) Peer review
D) Second data entry

12. Good Documentation Practices state records must be stored securely for how long?
A) 2 years after last subject
B) Duration of trial
C) 5 years after market approval
D) Specified in records SOP

13. According to GCP how should medical histories be documented as source data?
A) Verbatim in subject notes
B) Referenced to hospital records
C) Transcribed to CRF
D) Summarized in reports

14. What process ensures accuracy when transcribing source data to CRFs according to GCP?
A) Dual data entry
B) Check digit verification
C) Source data verification
D) Data masking

15. GCP guidance states what individual is responsible for trial records retention?
A) Principal investigator
B) Sponsor documents coordinator
C) Regulatory authorities

16. What approach to documentation according to GCP prevents duplicate records?
A) Version control
B) Blinding
C) Randomization
D) Unique identifiers

17. When are essential documents lists and indexes required according to GCP?
A) Beginning and end of trial
B) Annually during trial conduct
C) Upon regulatory or sponsor request
D) Ongoing basis throughout trial

18. Which process verifies accuracy of data responses according to GCP guidelines?
A) Double data entry
B) Case report audits
C) Source document review
D) Peer validation

19. What level of granularity does GCP require for adverse event documentation?
A) Listing in source notes
B) Verbatim transcription
C) High level summary
D) Line item on CRF

20. How should dates be documented in source records according to GCP?
D) No standard required

21. What method verifies source data accuracy according to GCP?
A) Data cleaning
B) Paraphrased records
C) Source data verification
D) Annotations

22. GCP guidance states how should records of delegation be maintained?
A) Signature sheet
B) Job descriptions
C) Authorization letters
D) Training certificates

23. According to GCP which individual reviews source data accuracy?
A) Medical monitor
B) Data manager
C) Independent auditor
D) Clinical monitor

24. Which role is responsible for trial master file organization according to GCP?
A) Data manager
B) Documents coordinator
C) Regulatory liaison
D) Principal investigator

25. When documenting changes to source data, GCP guidelines state the original entry should be:
A) Whited out
B) Single line-through
C) Overwritten legibly
D) Incompletely erased

26. How long must trial essential documents be retained according to GCP?
A) 2 years after completion
B) 5 years after completion
C) Product approval period
D) Specified in records SOP

27. Good documentation practices state all data should be immediately entered in source:
A) True
B) False
C) Only specified sources
D) Upon monitoring visit

28. According to GCP how should diagnostic tests/lab results be incorporated into source data?
A) Direct transcription into notes
B) Reference and file reports
C) Transfer onto CRF directly
D) Summarized on source worksheets

29. Which process verifies accuracy of eligibility documentation?
A) Chart review
B) Source verification
C) Second opinion
D) Self-reported

30. GCP guidance states which individual(s) have access to unblinded clinical data?
A) Sponsor medical personnel only
B) Specified unblinded team members
C) All research and safety staff
D) Investigator and sub-investigators

31. How should corrections to CRFs be documented according to GCP?
A) Whited out and initialed
B) Overwritten legibly
C)Crossed out single line and initialed
D) All changes must undergo regulatory review

32. What approach to documentation prevents incomplete collection according protocol?
A) Pre-coded fields
B) Pick lists
C)Free text entries
D) Blank CRFs

33.Which documentation describes the database design and metadata schema?
A)Data management plan
B)Data validation guidelines
C)CRF completion guidelines
D)Data dictionary

34.What approach verifies accurate transcription of source into CRFs according to GCP?
A) Independent data entry
B)Dual data entry
C)Parallel data entry
D) Single data entry

35.When conducting monitoring visits, what process does GCP require?
A)Source document review
B)CRF review
C)Investigator interview
D)All of the above

36.What guidance states use of identifiers on all clinical documentation?
A)hipaa 1996
B)GCP 1996
C)common rule
D)ISO 27799

37.According to GCP, how long must records of informed consent be retained?
A)Duration of trial
B)2 years after last subject
C)Product approval period
D)Minimum 15 years

38.What type of trial documentation verifies data was recorded prior to analysis?
A)Source data
D)Monitoring logs

39.Which documentation contains a record of consent process discussions?
B)Source notes
C)Regulatory submissions
D)Investigator’s brochure

40.What approach prevents unauthorized changes to clinical documentation?
B) Version control
D)Witness verification