CTA Trial Procedures 2 — Questions and Answers
Question 1: What is the purpose of a Protocol Deviation Report (PDR) in a clinical trial?
- To document and communicate any departure from the approved protocol (Correct answer)
- To request a protocol amendment from the sponsor
- To terminate a subject's participation in the trial
- To notify the IRB of a new investigator joining the site
Correct 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.
Question 2: During a clinical trial, when should a subject's informed consent be re-obtained?
- Only at the end of the study
- When significant new information becomes available that may affect the subject's willingness to continue (Correct answer)
- Annually regardless of protocol changes
- Only if the subject requests it in writing
Correct 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.
Question 3: What does 'blinding' refer to in the context of randomized controlled trials?
- Restricting data access to the biostatistics team only
- Withholding knowledge of treatment assignment from participants and/or investigators (Correct answer)
- Encrypting subject identifiers in the database
- Preventing site staff from viewing the study protocol
Correct 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.
Question 4: Which document serves as the primary reference for acceptable laboratory values and normal ranges at a clinical trial site?
- The Investigator's Brochure
- The site's certified laboratory reference ranges (Correct answer)
- The sponsor's standard operating procedures
- The ICH E6 guideline
Correct 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.
Question 5: What is the role of a Data Safety Monitoring Board (DSMB) in a clinical trial?
- To audit financial records of the sponsor
- To independently review accumulating safety and efficacy data and recommend trial continuation, modification, or termination (Correct answer)
- To approve changes to the case report form design
- To train site staff on data entry procedures
Correct 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.
Question 6: In a clinical trial, what is the purpose of stratified randomization?
- To assign subjects to treatment groups alphabetically by last name
- To ensure balanced distribution of key prognostic factors across treatment groups (Correct answer)
- To randomize subjects only after they complete baseline assessments
- To allow investigators to select the treatment group for each subject
Correct 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.
Question 7: 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?
- Immediately discontinue the subject without documentation
- Quietly remove the subject's data from the analysis
- Document the protocol deviation, notify the sponsor, and follow the protocol's guidance on continuation (Correct answer)
- Re-screen the subject using a different inclusion criterion
Correct 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.
CTA Trial Procedures 2
What is the purpose of a Protocol Deviation Report (PDR) in a clinical trial?