Trial Procedures 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 Trial Procedures flashcards as text
What is the purpose of a Protocol Deviation Report (PDR) in a clinical trial?
Answer: To document and communicate any departure from the approved protocol
A PDR documents and communicates any departure from the approved protocol to the sponsor and, when required, to the IRB/ethics committee.
During a clinical trial, when should a subject's informed consent be re-obtained?
Answer: When significant new information becomes available that may affect the subject's willingness to continue
Re-consent is required whenever significant new information emerges that could affect the subject's willingness to continue participation.
What does 'blinding' refer to in the context of randomized controlled trials?
Answer: Withholding knowledge of treatment assignment from participants and/or investigators
Blinding (masking) is a procedure where knowledge of the treatment assignment is withheld from subjects, investigators, or both to reduce bias.
Which document serves as the primary reference for acceptable laboratory values and normal ranges at a clinical trial site?
Answer: The site's certified laboratory reference ranges
The site's certified laboratory normal ranges are used to evaluate whether subject laboratory values are within acceptable limits.
What is the role of a Data Safety Monitoring Board (DSMB) in a clinical trial?
Answer: To independently review accumulating safety and efficacy data and recommend trial continuation, modification, or termination
A DSMB is an independent committee that monitors accumulating trial data to protect subject safety and ensure trial integrity.
In a clinical trial, what is the purpose of stratified randomization?
Answer: To ensure balanced distribution of key prognostic factors across treatment groups
Stratified randomization ensures that important prognostic variables are evenly distributed between treatment arms, reducing confounding.
What action should a CTA take if a subject enrolled in a clinical trial is found to have been ineligible based on a violation of an inclusion criterion discovered post-enrollment?
Answer: Document the protocol deviation, notify the sponsor, and follow the protocol's guidance on continuation
Protocol eligibility violations must be documented as deviations, reported to the sponsor, and managed per protocol and regulatory guidance.