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 11

Answer

45 CFR Part 46

Answer

21 CFR Part 50

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

To approve all protocol amendments before submission

Answer

To audit CRF completion rates at each site

Answer

To handle randomization and blinding procedures

Question 3

Under GCP, which document must a subject sign before participating in a clinical trial?

Accepted Answer

Informed consent form

Answer

Case Report Form

Answer

Data Management Plan

Answer

Protocol amendment

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 change to the protocol submitted to the IRB for approval

Answer

A planned interim analysis of study data

Answer

A site's failure to enroll the required number of subjects

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

NIH National Cancer Institute

Answer

ICH Secretariat

Answer

EMA Scientific Advice Working Party

Question 6

What is the purpose of a Trial Master File (TMF) in clinical research?

Accepted Answer

To collect and archive all essential documents that allow evaluation of trial conduct and data quality

Answer

To store only adverse event narratives for regulatory review

Answer

To house all randomization codes for the trial

Answer

To document all financial agreements between sponsors and sites