Protocol Development & Review Flashcards
7 cards from real CTA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Protocol Development & Review flashcards as text
During a protocol review, a CTA notices that the washout period between study treatments appears too short to eliminate carryover effects. What should the CTA do?
Answer: Document the concern and escalate to the clinical team or medical monitor for review
The CTA should document the concern and escalate to the appropriate clinical team members for scientific and medical review.
What is the significance of the 'primary endpoint' in a clinical trial protocol?
Answer: It is the main outcome measure used to determine whether the treatment achieves its intended effect
The primary endpoint is the pre-specified main outcome measure that determines whether the study's primary hypothesis is supported.
Which regulatory framework governs Good Clinical Practice (GCP) standards that must be reflected in US clinical trial protocols?
Answer: ICH E6(R2) and US FDA regulations (21 CFR Parts 50, 56, 312)
ICH E6(R2) and US FDA regulations (21 CFR Parts 50, 56, 312) together govern GCP standards for US clinical trials.
A protocol includes a 'sentinel dosing' approach in a Phase I trial. What does this mean?
Answer: One or two subjects receive the treatment first and are monitored before the rest of the cohort is dosed
Sentinel dosing means one or two subjects are dosed first and monitored for a defined period before the remaining cohort members receive treatment.
When a sponsor issues a new version of a protocol, how is version control typically managed in the document?
Answer: A version history table documents each version number, date, and summary of changes
Protocols use a version history table to document each revision, including version number, date of revision, and a summary of changes made.
In a multi-center clinical trial, what tool is typically used to ensure all sites implement the protocol uniformly?
Answer: A protocol training program with site-initiation visits and a study manual
Protocol training programs, site-initiation visits, and detailed study manuals ensure uniform implementation of the protocol across all sites.
What is the purpose of including 'exploratory endpoints' in a clinical trial protocol?
Answer: To generate hypotheses and additional insights that may inform future studies, without being powered for definitive conclusions
Exploratory endpoints generate hypothesis-generating data and additional insights but are not intended to provide definitive conclusions about treatment effects.