FDA / ICH reference questions

**Fast regulation search** Searched the local FDA/ICH regulation database and found **7 matching sources** for: _What are the CRA's responsibilities under ICH GCP 5.18.4?_ --- ## Q&A 1: What are the CRA's responsibilities under ICH GCP 5.18.4? **Category:** Monitoring **Source:** `ICH GCP E6(R2) Section 5.18.4` **Answer:** Under ICH GCP 5.18.4, the monitor/CRA should act as the main communication link between sponsor and investigator, verify that the investigator and staff remain qualified and informed, verify informed consent before participation, confirm the site follows the approved protocol/amendments, verify source documents and trial records are accurate, complete, current, and maintained, check CRF entries against source, confirm AEs/concomitant medications and missed visits are reported per protocol, and communicate deviations, data issues, and follow-up items to the sponsor and site. --- ## Q&A 2: What is the monitor's primary responsibility? **Category:** Monitoring **Source:** `ICH GCP 5.18.4` **Answer:** Per ICH GCP 5.18.4: verify (a) subjects' rights protected, (b) data accurate and verifiable, (c) trial conducted per protocol and GCP. Monitor is primary communication link between sponsor and investigator. --- ## Q&A 3: What is SDV (Source Data Verification)? **Category:** Monitoring **Source:** `ICH GCP 5.18.4` **Answer:** SDV is comparing source documents (original medical records) against CRF/EDC entries to verify accuracy and completeness. Per ICH GCP 5.18.4, the monitor must verify that reported data are accurate and consistent with source documents. --- ## Source 4: CRA Practice — Source Document Verification (SDV) Procedure **Reference:** `ICH GCP E6(R2) Section 5.18.4 + Industry Best Practice` **Category:** SDV **Match Score:** 0.4356 SDV is the process of comparing source documents against CRF/EDC entries to verify accuracy. PRACTICAL PROCEDURE: BEFORE SDV: 1. Request source documents in advance (schedule with site coordinator) 2. Review previous visit reports and open queries 3. Identify subjects and data points requiring 100% verification 4. Check regulatory binders and essential documents DURING SDV: 1. Compare each data point in source vs. CRF systematically 2. Verify: subject ID, visit date, AE/SAE entries, concomitant meds, protocol procedures 3. Check ICF dates (must be signed BEFORE any study procedure) 4. Verify eligibility criteria match enrollment records 5. Check query resolution: corrections were made properly 6. Document each subject reviewed in monitoring log 7. For EDC: check audit trail for late entries or back-dating AFTER SDV: 1. Document all discrepancies as queries 2. Summary of SDV in monitoring visit report 3. Follow up on unresolved items WHAT TO VERIFY PER ICH GCP 5.18.4: - Subjects' rights and well-being are protected - Reported data are accurate, complete, and verifiable from source documents - Site conducts trial according to protocol and GCP - Protocol deviations are identified and reported --- ## Source 5: CRA Practice — Informed Consent Form (ICF) Review Checklist **Reference:** `ICH GCP E6(R2) Section 4.8 + 21 CFR 50` **Category:** Regulatory **Match Score:** 0.402 During monitoring visits, CRAs must review ICFs for compliance. PRACTICAL CHECKLIST: 1. CORRECT VERSION: Verify the ICF matches the currently IRB-approved version 2. SIGNATURES: Subject and person obtaining consent must both sign and date 3. DATES: Subject's signature date must be BEFORE any study-mandated procedure 4. RE-CONSENT: If protocol changes, verify subjects were re-consented with updated ICF 5. RE-CONSENT: If new safety information emerges, verify subjects were re-consented 6. COPY TO SUBJECT: Verify subject received a copy of the signed ICF 7. LANGUAGE: If subject used a translated ICF, verify certified translation 8. WITNESS: If required per local regulation or IRB, verify witness signature 9. VULNERABLE SUBJECTS: Special consent procedures for children, mentally impaired, etc. 10. DOCUMENTATION: Re-consent or protocol amendment consent forms are filed in source COMMON FINDINGS: - ICF signed after first study procedure (critical finding) - Wrong version of ICF used - Missing subject or investigator signature - No copy provided to subject --- ## Q&A 6: What is Informed Consent? **Category:** GCP Basics **Source:** `ICH GCP 4.8` **Answer:** Informed consent is the process where a subject voluntarily confirms willingness to participate in a trial after being fully informed. Per ICH GCP 4.8, consent must be documented with a signed and dated ICF, and the subject must receive a copy. --- ## Source 7: ICH E6(R2) — Adverse Event (AE) and SAE Reporting **Reference:** `ICH GCP E6(R2) + 21 CFR 312.32` **Category:** Safety **Match Score:** 0.3123 All adverse events (AEs) observed or reported during a clinical trial must be recorded in the CRF and in source documents. Serious Adverse Events (SAEs) must be reported to the sponsor within 24 hours of the investigator's knowledge. The sponsor must then notify all participating investigators, IRBs/IECs, and regulatory authorities according to local requirements. Fatal or life-threatening SAEs must be reported to FDA within 7 days (for investigational new drugs) and other SAEs within 15 days. The investigator must follow SAEs until resolution or stabilization. --- *Tip: Try rephrasing your question for more targeted matches.*