CTA Good Clinical Practice & ICH Guidelines 3 — Questions and Answers
Question 1: ICH E6(R2) requires that informed consent be obtained before which of the following?
- Before any trial-specific procedures are performed (Correct answer)
- Before the sponsor approves the protocol
- Before the IRB completes its review
- Before randomization only
Correct answer: Before any trial-specific procedures are performed
GCP mandates that informed consent must be obtained prior to any trial-specific screening or treatment procedures being conducted.
Question 2: Which ICH guideline provides guidance on statistical principles for clinical trials, including randomization and blinding?
- ICH E3
- ICH E9 (Correct answer)
- ICH E6
- ICH E8
Correct answer: ICH E9
ICH E9 — 'Statistical Principles for Clinical Trials' — covers randomization, blinding, analysis populations, and handling of missing data.
Question 3: In the context of ICH E6(R2), 'source data' is defined as:
- Data transcribed onto the CRF after the original observation
- All information in original records and certified copies of original records (Correct answer)
- Electronic data captured directly into the EDC system only
- Lab results generated by the central laboratory
Correct answer: All information in original records and certified copies of original records
Source data includes all original records (paper or electronic) and certified copies that contain clinical trial information.
Question 4: Under GCP, what action must an investigator take when a protocol deviation that may affect subject safety occurs?
- Document it in the next quarterly report to the sponsor
- Report it promptly to the sponsor, IRB/IEC, and regulatory authority as required (Correct answer)
- Correct it without documentation to minimize regulatory burden
- Wait until the monitoring visit to disclose it
Correct answer: Report it promptly to the sponsor, IRB/IEC, and regulatory authority as required
Protocol deviations affecting subject safety must be promptly reported to the sponsor, IRB/IEC, and regulatory authorities according to applicable requirements.
Question 5: Which ICH guideline establishes the general considerations for clinical development planning, including dose-finding and early phase studies?
- ICH E8 (Correct answer)
- ICH E1
- ICH E7
- ICH E4
Correct answer: ICH E8
ICH E8 — 'General Considerations for Clinical Trials' — outlines the overall development framework including early phase, dose-finding, and confirmatory trials.
Question 6: When is it permissible under ICH E6(R2) for a legally acceptable representative (LAR) to provide consent on behalf of a subject?
- When the subject is unable to give personal informed consent due to incapacity (Correct answer)
- When the subject refuses consent but the investigator believes participation is beneficial
- When consent documentation is unavailable at the site
- When the sponsor waives the consent requirement for expedited enrollment
Correct answer: When the subject is unable to give personal informed consent due to incapacity
An LAR may consent when a subject lacks capacity to provide personal consent (e.g., due to cognitive impairment or emergency), provided applicable regulatory requirements are met.
Question 7: According to ICH E6(R2), sponsor monitoring should be risk-based. Which element is specifically introduced in the R2 addendum to support this approach?
- Centralized monitoring as a complement to on-site monitoring (Correct answer)
- Mandatory 100% source data verification for all trials
- Quarterly site visits regardless of risk
- Elimination of on-site monitoring for low-risk trials
Correct answer: Centralized monitoring as a complement to on-site monitoring
The R2 addendum emphasizes that centralized monitoring can supplement or replace some on-site monitoring based on a risk assessment, improving efficiency without compromising quality.
CTA Good Clinical Practice & ICH Guidelines 3
ICH E6(R2) requires that informed consent be obtained before which of the following?