CRA ICH-GCP Compliance 3 — Questions and Answers
Question 1: Which ICH-GCP section specifically addresses the investigator's responsibilities for investigational product accountability?
- ICH E6(R2) Section 4.6 (Correct answer)
- ICH E6(R2) Section 3.1
- ICH E6(R2) Section 5.14
- ICH E6(R2) Section 8.3
Correct answer: ICH E6(R2) Section 4.6
Section 4.6 of ICH E6(R2) outlines the investigator's responsibilities for accountability of the investigational product, including maintenance of accurate records.
Question 2: What is the significance of the 'Declaration of Helsinki' in relation to ICH-GCP guidelines?
- It supersedes ICH-GCP whenever there is a conflict between the two
- ICH-GCP was developed with consideration of the ethical principles in the Declaration of Helsinki (Correct answer)
- The Declaration of Helsinki is a regulatory requirement that replaces ethical review
- ICH-GCP guidelines explicitly reject the Declaration of Helsinki's principles
Correct answer: ICH-GCP was developed with consideration of the ethical principles in the Declaration of Helsinki
ICH E6(R2) states that the guideline was developed with consideration of current good clinical practices of the EU, Japan, the US, and the ethical principles of the Declaration of Helsinki.
Question 3: Under ICH-GCP, which of the following constitutes an 'essential document'?
- Only documents submitted to the regulatory authority during the approval process
- Documents that individually and collectively permit evaluation of the conduct of a trial and quality of data (Correct answer)
- Financial agreements between the sponsor and investigator only
- Internal sponsor communications about marketing strategy for the investigational product
Correct answer: Documents that individually and collectively permit evaluation of the conduct of a trial and quality of data
ICH E6(R2) Section 8 defines essential documents as those that individually and collectively permit evaluation of the conduct of a trial and the quality of data produced.
Question 4: When an IRB/IEC reviews a clinical trial, what is the primary ethical concern ICH-GCP requires them to address?
- Ensuring the sponsor achieves maximum financial return on the investigational product
- Safeguarding the rights, safety, and well-being of all trial subjects (Correct answer)
- Verifying that the investigator has adequate publication plans
- Confirming that the sponsor's budget is sufficient to complete the trial
Correct answer: Safeguarding the rights, safety, and well-being of all trial subjects
ICH E6(R2) states that the IRB/IEC's primary purpose is to safeguard the rights, safety, and well-being of all trial subjects.
Question 5: In a multi-center trial conducted under ICH-GCP, who is responsible for coordinating safety information across all sites?
- The lead investigator at the largest enrolling site
- The IRB/IEC at each participating site independently
- The sponsor (Correct answer)
- The regulatory authority of each country
Correct answer: The sponsor
The sponsor is responsible for the ongoing safety evaluation of the investigational product and for coordinating and reporting safety information across all participating sites.
Question 6: Under ICH E6(R2), what is required before a subject can be enrolled in a clinical trial?
- Written informed consent must be obtained from the subject or legally acceptable representative (Correct answer)
- Verbal agreement from the subject witnessed by two staff members
- A physician's order documenting the medical necessity of trial participation
- Regulatory approval of the consent form at least 60 days prior to enrollment
Correct answer: Written informed consent must be obtained from the subject or legally acceptable representative
ICH E6(R2) Section 4.8 requires that freely given, written informed consent be obtained from each subject prior to trial participation.
Question 7: What does ICH-GCP specify regarding the qualification of a clinical trial monitor?
- Monitors must be licensed physicians with at least five years of clinical experience
- Monitors should be trained in scientific and/or clinical disciplines and knowledgeable about GCP and regulatory requirements (Correct answer)
- Monitors are only required to have a high school diploma plus on-the-job training
- Monitors must hold a certification from the sponsor's internal training program only
Correct answer: Monitors should be trained in scientific and/or clinical disciplines and knowledgeable about GCP and regulatory requirements
ICH E6(R2) Section 5.18.2 states that monitors should have scientific and/or clinical knowledge sufficient to monitor the trial adequately and should be knowledgeable about GCP and applicable regulatory requirements.
CRA ICH-GCP Compliance 3
Which ICH-GCP section specifically addresses the investigator's responsibilities for investigational product accountability?