Certified Clinical Research Study Flashcards

During site close-out, the CRA confirms that all essential documents are filed, IP is reconciled, and staff is debriefed. Which document officially marks the end of a site's participation in a trial?

Answer: Site Close-Out Letter

The Site Close-Out Letter is the formal communication from the sponsor to the investigator confirming the site's participation in the study has ended.

Which ICH guideline specifically addresses the statistical principles for the design and analysis of confirmatory clinical trials?

Answer: ICH E9

ICH E9 (Statistical Principles for Clinical Trials) provides guidance on statistical methodology for confirmatory efficacy and safety trials.

A study subject becomes pregnant during a clinical trial of a teratogenic investigational compound. After being taken off study drug, what additional obligation typically applies?

Answer: The pregnancy must be reported as an SAE and followed to outcome

Pregnancies in trials of potentially teratogenic drugs are typically reportable SAEs, and pregnancy outcomes (including neonatal outcomes) must be tracked and reported.

Which of the following best describes 'audit trail' as it relates to electronic data capture (EDC) systems under 21 CFR Part 11?

Answer: A secure, computer-generated record that captures who made changes, what was changed, and when

21 CFR Part 11 requires EDC systems to maintain a secure, time-stamped audit trail of all data entries and changes attributable to the individual who made them.

In a double-blind, randomized clinical trial, who is permitted to access the randomization codes in an emergency?

Answer: The treating physician when unblinding is medically necessary for a subject's safety

Emergency unblinding is permitted when the treating physician determines that knowledge of treatment assignment is necessary to provide appropriate medical care to the subject.

A site investigator wants to add a new co-investigator to the trial team mid-study. What GCP-required steps must be completed before the new co-investigator can perform any study activities?

Answer: IRB approval, CV submission, GCP training documentation, and addition to the delegation log

New study personnel must have updated CVs on file, documented GCP training, IRB acknowledgment per site SOP, and be formally delegated responsibilities on the delegation of authority log.

What is the main distinction between an 'adverse event' (AE) and an 'adverse drug reaction' (ADR) in clinical trial terminology?

Answer: An ADR implies a causal relationship to the investigational product, while an AE does not

An AE is any unfavorable medical occurrence regardless of causality, whereas an ADR is an AE for which there is at least a reasonable possibility of a causal relationship to the study drug.