SCDM Regulatory Compliance and GCP 2 — Questions and Answers
Question 1: Which FDA regulation outlines requirements for the conduct of Investigational New Drug (IND) studies?
- 21 CFR Part 312 (Correct answer)
- 21 CFR Part 11
- 45 CFR Part 46
- 21 CFR Part 50
Correct answer: 21 CFR Part 312
21 CFR Part 312 governs the IND application process, including requirements for study design, sponsor responsibilities, and investigator obligations.
Question 2: What is the role of the Data Safety Monitoring Board (DSMB) in a clinical trial?
- To independently review accumulating safety and efficacy data at planned intervals (Correct answer)
- To approve all protocol amendments before submission
- To audit CRF completion rates at each site
- To handle randomization and blinding procedures
Correct answer: To independently review accumulating safety and efficacy data at planned intervals
A DSMB is an independent group that reviews unblinded accumulating data to ensure participant safety and study integrity, recommending continuation, modification, or stopping.
Question 3: Under GCP, which document must a subject sign before participating in a clinical trial?
- Informed consent form (Correct answer)
- Case Report Form
- Data Management Plan
- Protocol amendment
Correct answer: Informed consent form
GCP requires that each participant sign an IRB/IEC-approved informed consent form prior to any study procedures, ensuring voluntary and informed participation.
Question 4: What is a 'protocol deviation' in clinical research?
- Any departure from the approved study protocol that is not pre-approved (Correct answer)
- A change to the protocol submitted to the IRB for approval
- A planned interim analysis of study data
- A site's failure to enroll the required number of subjects
Correct answer: Any departure from the approved study protocol that is not pre-approved
A protocol deviation is any unplanned, unapproved departure from the study protocol that may or may not affect subject safety or data integrity.
Question 5: Which agency publishes the FDA Bioresearch Monitoring (BIMO) guidance for clinical data management?
- FDA Center for Drug Evaluation and Research (CDER) (Correct answer)
- NIH National Cancer Institute
- ICH Secretariat
- EMA Scientific Advice Working Party
Correct answer: FDA Center for Drug Evaluation and Research (CDER)
The FDA's CDER publishes BIMO guidance documents that outline inspection expectations for clinical investigators, sponsors, monitors, and IRBs.
Question 6: What is the purpose of a Trial Master File (TMF) in clinical research?
- To collect and archive all essential documents that allow evaluation of trial conduct and data quality (Correct answer)
- To store only adverse event narratives for regulatory review
- To house all randomization codes for the trial
- To document all financial agreements between sponsors and sites
Correct answer: To collect and archive all essential documents that allow evaluation of trial conduct and data quality
The TMF is a comprehensive collection of essential documents demonstrating that a trial was conducted in compliance with GCP, protocols, and applicable regulations.
SCDM Regulatory Compliance and GCP 2
Which FDA regulation outlines requirements for the conduct of Investigational New Drug (IND) studies?