SOCRA - Society of Clinical Research Associates ICH Good Clinical Practice Questions and Answers 2 — Questions and Answers
Question 1: What are the 13 principles of ICH-GCP Section 2?
- Drug manufacturing guidelines
- Fundamental principles including ethical conduct, scientific soundness, participant rights, and data quality (Correct answer)
- Lab testing requirements
- Phase III principles only
Correct answer: Fundamental principles including ethical conduct, scientific soundness, participant rights, and data quality
Section 2 contains 13 principles covering ethical conduct, scientific soundness, participant rights, qualified personnel, consent, and data quality.
Principles include: ethical conduct per Helsinki, benefits justify risks, subject rights take priority, sufficient data support the trial, scientific soundness, qualified physicians and personnel, freely given consent, confidentiality, GMP compliance, quality systems, and record confidentiality.
Question 2: What are sponsor monitoring responsibilities per ICH E6(R2)?
- Not required to monitor
- Must develop monitoring plans, ensure qualified monitors, and verify compliance, data accuracy, and safety (Correct answer)
- Only CRO responsibility
- Only monitor drug supply
Correct answer: Must develop monitoring plans, ensure qualified monitors, and verify compliance, data accuracy, and safety
Section 5.18 requires developing monitoring plans, appointing qualified monitors, and conducting on-site and centralized monitoring.
Sponsors must develop risk-based monitoring, appoint qualified monitors, determine appropriate monitoring extent, ensure verification of consent, compliance, data, IP management, AE reporting, and documents, and implement centralized monitoring.
Question 3: What is the investigator's IP responsibility per ICH-GCP?
- No responsibility
- Ensure proper storage, dispensing, accountability, and return or destruction per protocol (Correct answer)
- Only pharmacist responsible
- Only prescribes
Correct answer: Ensure proper storage, dispensing, accountability, and return or destruction per protocol
Per Section 4.6, the investigator is responsible for IP accountability including storage, dispensing, documentation, and return.
Products must be used only per protocol, accountability responsibilities assigned, accurate records maintained, storage per instructions, use within shelf life, proper use explained to participants, and IP not supplied outside the trial.
Question 4: What does ICH E6(R2) say about quality management?
- Not addressed
- Sponsors should implement quality management with risk-based approaches for participant protection and data reliability (Correct answer)
- Manufacturing only
- Only FDA inspectors handle quality
Correct answer: Sponsors should implement quality management with risk-based approaches for participant protection and data reliability
Addendum 5.0 requires quality management including prospective risk identification and risk-based monitoring.
Key requirements: proportionate quality management, prospective risk identification, risk control strategies, risk-based monitoring, quality tolerance limits, ongoing risk review, and integration into all trial aspects.
Question 5: What are protocol deviation reporting requirements?
- Never need reporting
- Investigator must document and report to sponsor, IRB, and regulatory authorities (Correct answer)
- Only sponsor reports
- Reported at completion
Correct answer: Investigator must document and report to sponsor, IRB, and regulatory authorities
Per ICH E6, deviations should not occur without agreement except to eliminate hazards. All must be documented and reported.
Investigators should not deviate without sponsor and IRB agreement except to eliminate immediate hazards. All deviations must be documented with descriptions, reasons, and corrective actions, and reported as required.
Question 6: How does ICH-GCP define IRB/IEC responsibilities?
- No defined role
- Protect rights, safety, and well-being by reviewing protocols, consent forms, and investigator qualifications (Correct answer)
- Only handles finances
- Oversees manufacturing
Correct answer: Protect rights, safety, and well-being by reviewing protocols, consent forms, and investigator qualifications
Section 3: the IRB/IEC safeguards rights, safety, and well-being through independent review and approval.
Responsibilities include reviewing protocols, amendments, consent forms, recruitment procedures, investigator qualifications, and safety information. Diverse membership with non-scientific and independent members required.
SOCRA - Society of Clinical Research Associates ICH Good Clinical Practice Questions and Answers 2
What are the 13 principles of ICH-GCP Section 2?