CPI Clinical Documentation & Records 3 — Questions and Answers
Question 1: Which document formally defines the data to be collected, the CRF structure, and the validation rules for a clinical trial?
- The investigator brochure
- The data management plan (Correct answer)
- The clinical study report
- The statistical analysis plan
Correct answer: The data management plan
The data management plan (DMP) specifies how data will be collected, managed, and validated throughout the trial, including CRF design and edit checks.
Question 2: When must a serious adverse event (SAE) be documented in the source record?
- Within 30 days of occurrence
- At the next scheduled visit
- As soon as it is identified or reported by the subject (Correct answer)
- Only when the investigator determines it is study-related
Correct answer: As soon as it is identified or reported by the subject
GCP requires contemporaneous documentation; SAEs must be recorded in the source record as soon as they are identified or reported.
Question 3: A monitor reviewing source documents notices that several lab values are recorded in the CRF but cannot be found in the hospital chart. This situation is called:
- Data fabrication
- A missing data point
- A source data verification failure or data inconsistency (Correct answer)
- An acceptable transcription method
Correct answer: A source data verification failure or data inconsistency
When CRF data cannot be traced to a source document, this represents a source data verification (SDV) failure indicating a data integrity concern.
Question 4: In electronic records, 21 CFR Part 11 requires that electronic signatures be:
- Optionally linked to the signer's identity
- Legally binding only if witnessed
- Linked to their respective electronic records and include the printed name, date/time, and meaning of signature (Correct answer)
- Applied only by the principal investigator
Correct answer: Linked to their respective electronic records and include the printed name, date/time, and meaning of signature
21 CFR Part 11 mandates that electronic signatures include the printed name of the signer, date/time of signing, and the meaning of the signature (e.g., approval, review).
Question 5: Protocol amendments that change study procedures must be reflected in the source documents by:
- Retroactively updating all prior visit notes
- Documenting the amendment approval date and updating procedures in subsequent visit notes (Correct answer)
- Destroying prior records and re-documenting under the new protocol
- No change to source documents is required for amendments
Correct answer: Documenting the amendment approval date and updating procedures in subsequent visit notes
Once an amendment is approved, subsequent documentation should reflect the updated procedures, noting the amendment effective date in the records.
Question 6: When a subject withdraws from a clinical trial, the investigator should document:
- Nothing, as the subject's data is invalidated upon withdrawal
- The subject's reason for withdrawal, last contact date, and any follow-up safety data obtained (Correct answer)
- Only that the subject withdrew, with no further information required
- Withdrawal in the sponsor's database only, not in site records
Correct answer: The subject's reason for withdrawal, last contact date, and any follow-up safety data obtained
GCP requires documentation of the reason for withdrawal, date of last contact, and any available safety follow-up data to ensure complete and accurate records.
Question 7: Which term describes the process of comparing CRF data against the original source documents at the clinical site?
- Data cleaning
- Central statistical monitoring
- Source data verification (SDV) (Correct answer)
- Remote data capture validation
Correct answer: Source data verification (SDV)
Source data verification (SDV) is the monitoring activity of checking CRF data against source documents to confirm accuracy and completeness.
CPI Clinical Documentation & Records 3
Which document formally defines the data to be collected, the CRF structure, and the validation rules for a clinical trial?