CTA Trial Procedures 3 — Questions and Answers
Question 1: What is the primary purpose of source data verification (SDV) during a monitoring visit?
- To re-train site staff on data entry
- To confirm that data recorded in the CRF accurately reflects the original source documents (Correct answer)
- To approve the site's laboratory certifications
- To update the investigator's CV on file
Correct answer: To confirm that data recorded in the CRF accurately reflects the original source documents
SDV ensures that CRF data accurately reflects source documents, maintaining data integrity and regulatory compliance.
Question 2: Which GCP principle requires that clinical trial data be attributable, legible, contemporaneous, original, and accurate?
- The CONSORT principle
- The ALCOA principle (Correct answer)
- The CIOMS principle
- The Helsinki principle
Correct answer: The ALCOA principle
The ALCOA principle (Attributable, Legible, Contemporaneous, Original, Accurate) defines the required qualities for clinical trial data.
Question 3: A clinical trial subject reports a new medication they started taking. What is the CTA's first responsibility?
- Tell the subject to stop the new medication immediately
- Record the concomitant medication in the subject's trial records and assess potential interactions per protocol (Correct answer)
- Report the medication to the FDA directly
- Withdraw the subject from the trial without informing the PI
Correct answer: Record the concomitant medication in the subject's trial records and assess potential interactions per protocol
Concomitant medications must be documented in trial records and evaluated for protocol compliance and potential interactions.
Question 4: What is the standard requirement for retaining essential documents after the completion of a clinical trial under ICH E6?
- 2 years after trial completion
- At least 2 years after the last approval of a marketing application or at least 2 years after formal discontinuation (Correct answer)
- 5 years from the date of the first subject enrolled
- 10 years from the last subject's last visit
Correct answer: At least 2 years after the last approval of a marketing application or at least 2 years after formal discontinuation
ICH E6 requires essential documents to be retained for at least 2 years after the last marketing application approval or 2 years after formal discontinuation.
Question 5: During a clinical trial, an investigator wants to make a change to the protocol before receiving sponsor and IRB approval. What should the CTA advise?
- Allow the change only if the investigator documents it in a deviation report afterward
- Proceed if fewer than five subjects are affected
- The change cannot be implemented until the sponsor approves an amendment and the IRB approves the change (Correct answer)
- Proceed if the change improves subject safety
Correct answer: The change cannot be implemented until the sponsor approves an amendment and the IRB approves the change
Protocol changes require sponsor and IRB/ethics committee approval before implementation, except in cases of immediate safety concerns.
Question 6: What is 'double data entry' used for in clinical trials?
- Entering data in two separate databases for backup purposes
- Having two different operators independently enter the same data to identify and reduce transcription errors (Correct answer)
- Recording data in both the CRF and source document simultaneously
- Encoding subject identifiers in two formats for privacy
Correct answer: Having two different operators independently enter the same data to identify and reduce transcription errors
Double data entry involves two independent operators entering the same data so discrepancies can be identified and corrected to improve accuracy.
Question 7: What is a 'washout period' in a crossover clinical trial design?
- A cleaning procedure for study equipment between subjects
- A period between treatment phases during which the effects of the previous treatment are allowed to dissipate (Correct answer)
- The time required to analyze samples after collection
- The interval between IRB review cycles
Correct answer: A period between treatment phases during which the effects of the previous treatment are allowed to dissipate
A washout period is a specified time between crossover treatments to ensure the first treatment's effects do not carry over into the second phase.
CTA Trial Procedures 3
What is the primary purpose of source data verification (SDV) during a monitoring visit?