CPI CPI Clinical Site Operations & Investigational Product 1 — Questions and Answers
Question 1: What is the primary purpose of a site initiation visit (SIV) conducted before a clinical trial begins?
- To train site staff on the protocol, procedures, and regulatory requirements (Correct answer)
- To enroll the first cohort of participants
- To audit the site's financial records
- To submit the initial IND application
Correct answer: To train site staff on the protocol, procedures, and regulatory requirements
The SIV trains site personnel on protocol requirements, study procedures, data collection, and regulatory responsibilities before enrollment begins.
Question 2: Which document serves as the definitive record of staff authorized to perform specific tasks on a clinical trial site?
- Site Delegation Log (Delegation of Authority Log) (Correct answer)
- Protocol Synopsis
- Site Feasibility Questionnaire
- Master File Index
Correct answer: Site Delegation Log (Delegation of Authority Log)
The Delegation of Authority Log records each staff member's name, role, and the specific study tasks they are authorized to perform.
Question 3: What is the required action when a site staff member who has delegated study responsibilities leaves the institution?
- Update the delegation log, retrain a replacement, and notify the sponsor/CRO (Correct answer)
- Simply reassign tasks verbally to available staff
- Pause the study until a replacement is hired
- File an amendment with the FDA
Correct answer: Update the delegation log, retrain a replacement, and notify the sponsor/CRO
Staff departures require updating the delegation log, ensuring replacement staff are trained and credentialed, and notifying the sponsor or CRO.
Question 4: What does 'source document' refer to in clinical trial terminology?
- The original record where study data are first captured, such as medical charts or lab printouts (Correct answer)
- The final version of the Case Report Form submitted to the sponsor
- The IRB-approved protocol
- The participant's billing record
Correct answer: The original record where study data are first captured, such as medical charts or lab printouts
Source documents are the original records where study data are first captured, and they serve as the basis for verifying data entered on Case Report Forms.
Question 5: According to GCP guidelines, how must corrections be made to a paper Case Report Form (CRF)?
- Draw a single line through the error, write the correct value, date, and initial the change (Correct answer)
- Use correction fluid (white-out) to cover the error and rewrite
- Shred the page and create a new CRF page
- Simply erase the incorrect value and write the correct one
Correct answer: Draw a single line through the error, write the correct value, date, and initial the change
GCP requires corrections be made by drawing a single line through the error (leaving it legible), writing the correct value, and dating and initialing the change.
Question 6: What is the primary purpose of a monitoring visit conducted by a sponsor's Clinical Research Associate (CRA)?
- To verify data accuracy, protocol compliance, and participant safety at the site (Correct answer)
- To collect payments owed to site staff
- To conduct interim statistical analysis
- To review the site's operational budget
Correct answer: To verify data accuracy, protocol compliance, and participant safety at the site
Monitoring visits verify that study data are accurate and complete, the protocol is being followed, and participant safety is being maintained.
CPI CPI Clinical Site Operations & Investigational Product 1
What is the primary purpose of a site initiation visit (SIV) conducted before a clinical trial begins?