SOCRA - Society of Clinical Research Associates ICH Good Clinical Practice Questions and Answers 3 — Questions and Answers
Question 1: What is the significance of ICH E6(R2) vs the original?
- No differences
- R2 introduced risk-based monitoring, quality management, and updated electronic records requirements (Correct answer)
- R2 eliminated consent
- R2 only applies in Europe
Correct answer: R2 introduced risk-based monitoring, quality management, and updated electronic records requirements
R2 introduced risk-based monitoring, quality management, updated electronic records requirements, and proportionate risk-based approaches.
Key additions: quality management system approach, risk-based monitoring, updated electronic record requirements, proportionate risk-based approaches, enhanced CRO oversight, and clearer centralized monitoring expectations.
Question 2: What are investigator consent obligations per ICH E6?
- Can delegate entirely
- Must personally ensure adequate consent is freely given before and throughout the study (Correct answer)
- Only IRB responsibility
- Written consent never required
Correct answer: Must personally ensure adequate consent is freely given before and throughout the study
Per Section 4.8, the investigator must obtain consent before trial activities, ensure understanding, and update consent as needed.
Must obtain consent before any trial procedures, provide oral and written information in understandable language, allow adequate time, not coerce, re-consent when new information arises, use IRB-approved forms, and ensure subjects receive a signed copy.
Question 3: What are GCP data handling and record keeping requirements?
- No specific requirements
- All data must be recorded, handled, and stored to allow accurate reporting, interpretation, verification per data integrity standards (Correct answer)
- Only electronic needs special handling
- Data can be discarded after the report
Correct answer: All data must be recorded, handled, and stored to allow accurate reporting, interpretation, verification per data integrity standards
ICH E6 requires accurate recording, handling, and storage enabling reporting, interpretation, and verification while maintaining integrity.
Data must be accurately recorded, CRFs must capture all required data, changes must be traceable, electronic systems validated, data securely stored, confidentiality maintained, and records retained for required periods.
Question 4: How should emergency use of investigational product be handled?
- Never permitted
- FDA allows emergency use when no alternatives exist, requiring retrospective IRB notification and IND reporting (Correct answer)
- Only sponsor authorizes
- Requires a new Phase I trial
Correct answer: FDA allows emergency use when no alternatives exist, requiring retrospective IRB notification and IND reporting
Per 21 CFR 312.310, emergency use is permitted when no comparable alternatives exist, with retrospective IRB notification within 5 days.
Requirements: life-threatening situation, no comparable alternative, sufficient evidence of potential benefit, and treatment under existing protocol not possible. IRB notification within 5 working days, emergency IND submission.
Question 5: What are CRO responsibilities under ICH-GCP?
- No responsibilities
- CROs accepting delegated duties assume the same obligations as the sponsor for those duties (Correct answer)
- Only data entry
- Replace the sponsor entirely
Correct answer: CROs accepting delegated duties assume the same obligations as the sponsor for those duties
Per Section 5.2, CROs assume sponsor obligations for delegated duties, though the sponsor retains ultimate responsibility.
Transfer must be in writing specifying delegated duties. CRO must implement quality management. Sponsor must maintain oversight. Ultimate responsibility for quality and data integrity remains with the sponsor.
Question 6: What does ICH E6 require for investigator safety reporting?
- No reporting to sponsors needed
- Investigators must report all AEs and SAEs per protocol and regulatory timelines (Correct answer)
- Only fatal events
- Only annually
Correct answer: Investigators must report all AEs and SAEs per protocol and regulatory timelines
Per Section 4.11, investigators must promptly report all AEs and SAEs, with SAEs requiring immediate notification.
All AEs and lab abnormalities critical to safety must be reported per protocol. SAEs typically within 24 hours. Follow-up reports as needed. The protocol should clearly specify immediate vs. routine reporting.
SOCRA - Society of Clinical Research Associates ICH Good Clinical Practice Questions and Answers 3
What is the significance of ICH E6(R2) vs the original?