CRA Site Initiation & Monitoring Visits 2 — Questions and Answers
Question 1: During a Site Initiation Visit (SIV), which document confirms the site has received and reviewed the final approved protocol?
- Protocol signature page signed by the PI (Correct answer)
- IRB approval letter
- Site feasibility questionnaire
- Investigator's Brochure receipt log
Correct answer: Protocol signature page signed by the PI
The protocol signature page signed by the Principal Investigator documents that the PI has reviewed and accepted responsibility for conducting the study per the approved protocol.
Question 2: A CRA discovers during a monitoring visit that a sub-investigator was added to the study team but was not submitted to the IRB. What is the correct immediate action?
- Note it as a minor deviation and continue monitoring
- Advise the site to submit an amendment to the IRB before the sub-investigator sees any subjects (Correct answer)
- Remove the sub-investigator from all future visits
- Report directly to the FDA without notifying the sponsor
Correct answer: Advise the site to submit an amendment to the IRB before the sub-investigator sees any subjects
Any new personnel conducting study procedures must be approved by the IRB before participating; the site must submit an amendment and receive approval prior to that individual's involvement.
Question 3: What is the primary purpose of source data verification (SDV) during a monitoring visit?
- To assess the site's financial compliance
- To confirm that data in the CRF accurately reflects original source records (Correct answer)
- To evaluate the investigator's clinical competency
- To verify that all staff have completed GCP training
Correct answer: To confirm that data in the CRF accurately reflects original source records
SDV ensures data integrity by comparing case report form entries directly against original source documents such as medical records and lab reports.
Question 4: During a routine monitoring visit, a CRA finds that informed consent was obtained AFTER the subject completed the screening visit procedures. This constitutes:
- A minor protocol deviation requiring only a log entry
- A serious protocol deviation that must be reported to the IRB and sponsor (Correct answer)
- An acceptable practice if the subject later signed the consent form
- A documentation issue that can be corrected with a backdated consent
Correct answer: A serious protocol deviation that must be reported to the IRB and sponsor
Obtaining informed consent after study procedures begin is a serious deviation because it violates the subject's right to consent prior to participation and must be reported.
Question 5: At a Site Initiation Visit, which item in the Investigator Site File (ISF) should the CRA confirm is current and site-specific?
- A copy of the sponsor's SOP index
- Laboratory normal reference ranges for the site's local lab (Correct answer)
- The CRO's organizational chart
- The sponsor's financial disclosure forms
Correct answer: Laboratory normal reference ranges for the site's local lab
Laboratory normal reference ranges must reflect the specific lab used by the site and must be current, as they are used to evaluate subject safety data.
Question 6: A monitoring visit report should be sent to the site within what generally accepted industry timeframe?
- 5 business days
- 10 business days (Correct answer)
- 30 calendar days
- 60 calendar days
Correct answer: 10 business days
Industry standard and most sponsor SOPs require the monitoring visit report to be distributed within approximately 10 business days of the visit.
Question 7: During a monitoring visit, the CRA confirms that drug accountability records show a discrepancy between dispensed and returned quantities. The FIRST step is to:
- Immediately lock the drug storage area
- Discuss the discrepancy with the site pharmacist or coordinator to determine the cause (Correct answer)
- File a complaint with the DEA
- Withdraw the site from the study
Correct answer: Discuss the discrepancy with the site pharmacist or coordinator to determine the cause
Investigating the root cause by discussing with site staff is the first step to determine whether the discrepancy reflects a documentation error, diversion, or other issue.
CRA Site Initiation & Monitoring Visits 2
During a Site Initiation Visit (SIV), which document confirms the site has received and reviewed the final approved protocol?