CRA ICH-GCP Compliance 2 — Questions and Answers
Question 1: Under ICH E6(R2), what is the sponsor's primary responsibility regarding a Contract Research Organization (CRO)?
- The CRO assumes all regulatory liability once contracted
- The sponsor transfers full responsibility and is no longer accountable
- The sponsor retains ultimate responsibility for trial quality and compliance (Correct answer)
- The sponsor and CRO share equal legal liability for all trial activities
Correct answer: The sponsor retains ultimate responsibility for trial quality and compliance
ICH E6(R2) states that the sponsor retains ultimate responsibility for the quality and integrity of the trial data even when duties are delegated to a CRO.
Question 2: Which ICH-GCP principle requires that each individual involved in conducting a trial be qualified by education, training, and experience?
- Principle of minimization of risk
- Principle of qualified personnel (Correct answer)
- Principle of independent ethics oversight
- Principle of data integrity
Correct answer: Principle of qualified personnel
ICH E6(R2) Principle 2.8 specifies that each individual involved in conducting a trial must be qualified by education, training, and experience to perform their tasks.
Question 3: What does ICH-GCP require regarding the retention of essential documents after trial completion?
- Documents must be retained for at least 2 years after trial completion
- Documents must be retained for at least 15 years for all trials
- Documents must be retained for the period required by applicable regulatory requirements (Correct answer)
- Documents may be destroyed once the regulatory submission is approved
Correct answer: Documents must be retained for the period required by applicable regulatory requirements
ICH E6(R2) Section 4.9.5 requires that records be retained for the period specified by applicable regulatory requirements, which varies by jurisdiction.
Question 4: In ICH-GCP, which of the following best describes 'blinding' in the context of a clinical trial?
- A procedure to prevent adverse event reporting
- A method where one or more parties are unaware of treatment assignment (Correct answer)
- A requirement to conceal protocol amendments from subjects
- A technique to mask data entry errors from monitors
Correct answer: A method where one or more parties are unaware of treatment assignment
Blinding (masking) is a procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s) to reduce potential bias.
Question 5: According to ICH-GCP, when must a sponsor submit safety reports for unexpected serious adverse drug reactions?
- Within 7 calendar days for fatal/life-threatening events; 15 days for others (Correct answer)
- Within 24 hours for all serious adverse events regardless of severity
- Within 30 days for all unexpected adverse drug reactions
- Within 10 business days for unexpected serious adverse events only
Correct answer: Within 7 calendar days for fatal/life-threatening events; 15 days for others
ICH E6(R2) and ICH E2A require expedited reporting of unexpected SARs: 7 calendar days for fatal or life-threatening events and 15 calendar days for other unexpected serious ADRs.
Question 6: What is the role of the 'Data Safety Monitoring Board' (DSMB) as referenced in ICH-GCP guidelines?
- It replaces the IRB/IEC for ongoing safety reviews
- It is an independent group that reviews accumulating data to recommend trial continuation, modification, or termination (Correct answer)
- It audits the sponsor's financial records to ensure trial funding integrity
- It functions as the regulatory authority's representative at each trial site
Correct answer: It is an independent group that reviews accumulating data to recommend trial continuation, modification, or termination
A DSMB is an independent group that periodically reviews accumulating safety and efficacy data and advises the sponsor on whether to continue, modify, or stop the trial.
Question 7: Under ICH E6(R2), what must be done if a protocol deviation occurs at a clinical trial site?
- The deviation must be corrected silently without documentation if minor
- The investigator must document and explain the deviation; significant deviations must be reported to the sponsor and IRB/IEC (Correct answer)
- All deviations require immediate trial suspension until the IRB approves resumption
- Protocol deviations are only reportable if they result in a serious adverse event
Correct answer: The investigator must document and explain the deviation; significant deviations must be reported to the sponsor and IRB/IEC
ICH E6(R2) requires that investigators document protocol deviations and that significant deviations be reported to the sponsor, IRB/IEC, and regulatory authorities as applicable.
CRA ICH-GCP Compliance 2
Under ICH E6(R2), what is the sponsor's primary responsibility regarding a Contract Research Organization (CRO)?