SCDM Regulatory Compliance and GCP 2

Question 1

Which FDA regulation outlines requirements for the conduct of Investigational New Drug (IND) studies?

Accepted Answer

21 CFR Part 312

Answer

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?

Accepted Answer

To independently review accumulating safety and efficacy data at planned intervals

Answer

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?

Accepted Answer

Informed consent form

Answer

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?

Accepted Answer

Any departure from the approved study protocol that is not pre-approved

Answer

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?

Accepted Answer

FDA Center for Drug Evaluation and Research (CDER)

Answer

The FDA's CDER publishes BIMO guidance documents that outline inspection expectations for clinical investigators, sponsors, monitors, and IRBs.

SCDM - Society for Clinical Data Management Practice Test

SCDM - Society for Clinical Data Management Practice Test

SCDM Regulatory Compliance and GCP 2