SOCRA Knowledge 2 — Questions and Answers
Question 1: Under FDA regulations, how long must clinical trial records be retained?
- 1 year after study completion
- 2 years after the last approval of a marketing application (Correct answer)
- 5 years after study completion
- Records never need to be retained
Correct answer: 2 years after the last approval of a marketing application
Per 21 CFR 312.62, investigators must retain records for 2 years after the last approval of a marketing application or 2 years after investigation is discontinued.
FDA regulations (21 CFR 312.62) require that an investigator retain records for a period of 2 years following the date a marketing application is approved, or 2 years after the investigation is discontinued and FDA is notified.
Question 2: What is the primary function of a Data Safety Monitoring Board (DSMB)?
- To manage the study budget
- To independently monitor participant safety and study data integrity during a trial (Correct answer)
- To recruit participants
- To write the final study report
Correct answer: To independently monitor participant safety and study data integrity during a trial
A DSMB is an independent committee that monitors safety data and study conduct, with the authority to recommend modifications or termination.
A DSMB, also called a Data Monitoring Committee (DMC), is an independent group that periodically reviews unblinded data from an ongoing clinical trial. Their responsibilities include monitoring participant safety, evaluating efficacy at interim analyses, and recommending trial continuation or termination.
Question 3: What is the purpose of an audit trail in electronic data systems?
- To track the study budget
- To provide a secure, computer-generated record of all data changes with timestamps (Correct answer)
- To monitor recruitment rates
- To generate statistical reports
Correct answer: To provide a secure, computer-generated record of all data changes with timestamps
An audit trail is a secure, computer-generated, time-stamped electronic record that allows reconstruction of events related to data creation, modification, and deletion.
Per 21 CFR Part 11 and ICH E6(R2), electronic systems used in clinical trials must maintain a complete audit trail. Every data entry, modification, or deletion is recorded with the identity of the person, date/time, reason, and both original and new values.
Question 4: What is a protocol deviation versus a protocol violation?
- They are the same thing
- A deviation is any departure from the protocol; a violation is a deviation that affects safety or data integrity (Correct answer)
- A deviation is more serious
- A violation only occurs when the sponsor makes changes
Correct answer: A deviation is any departure from the protocol; a violation is a deviation that affects safety or data integrity
A deviation is any unplanned departure from the protocol, while a violation is a significant deviation that may affect participant safety, rights, or data integrity.
A violation is a more serious subset that materially affects participant safety, rights, or welfare, or the completeness and reliability of study data. Violations typically require reporting to the IRB/ethics committee and may necessitate corrective and preventive actions.
Question 5: What is the Belmont Report and why is it significant?
- The FDA's drug approval guideline
- It identifies basic ethical principles for human subjects research: respect, beneficence, and justice (Correct answer)
- Manufacturing standards for drugs
- Statistical methods for clinical trials
Correct answer: It identifies basic ethical principles for human subjects research: respect, beneficence, and justice
The Belmont Report (1979) identifies three core ethical principles: respect for persons, beneficence, and justice.
The Belmont Report established three core ethical principles: Respect for Persons (autonomy and protection of vulnerable populations), Beneficence (maximizing benefits, minimizing harm), and Justice (fair distribution of research burdens and benefits). It influenced federal regulations (45 CFR 46).
Question 6: What is source data verification (SDV)?
- Creating new source documents
- Comparing CRF entries with original source documents to ensure accuracy (Correct answer)
- Verifying IRB approval
- Checking investigational product manufacturing
Correct answer: Comparing CRF entries with original source documents to ensure accuracy
SDV is the process of comparing data in the CRF against original source documents to confirm accuracy and completeness.
SDV is a critical monitoring activity where the CRA compares CRF data with original source documents such as medical records, lab reports, and pharmacy logs. ICH E6(R2) introduced risk-based monitoring approaches that may reduce SDV for lower-risk data.
SOCRA Knowledge 2
Under FDA regulations, how long must clinical trial records be retained?