FDA / ICH reference questions

**Fast regulation search** Searched the local FDA/ICH regulation database and found **6 matching sources** for: _What is the SAE reporting timeline under FDA regulations?_ --- ## Q&A 1: What is the SAE reporting timeline? **Category:** Safety **Source:** `21 CFR 312.32` **Answer:** Investigator reports SAEs to sponsor within 24 hours. Sponsor reports fatal/life-threatening SAEs to FDA within 7 days (IND), other SAEs within 15 days. Per 21 CFR 312.32. --- ## Q&A 2: What is the difference between AE and SAE? **Category:** Safety **Source:** `ICH GCP, 21 CFR 312.32` **Answer:** AE: any untoward medical occurrence. SAE: results in death, life-threatening, requires hospitalization, causes disability, congenital anomaly, or requires intervention to prevent permanent impairment. --- ## Source 3: ICH E6(R2) — Adverse Event (AE) and SAE Reporting **Reference:** `ICH GCP E6(R2) + 21 CFR 312.32` **Category:** Safety **Match Score:** 1.96 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. --- ## Q&A 4: What is SAE Reconciliation? **Category:** Safety **Source:** `Industry Practice` **Answer:** Comparing SAEs reported by investigator to sponsor vs SAEs in the clinical database. Ensures all SAEs captured and reported. Done each visit and before database lock. --- ## Q&A 5: What is the purpose of a Site Initiation Visit (SIV)? **Category:** Monitoring **Source:** `ICH GCP 4.0-4.3, 5.6` **Answer:** Prepares site to begin enrollment. Covers: protocol training, ICF process, IP handling, SAE reporting, CRF completion, regulatory documents, facility inspection. Confirmation letter issued after SIV. --- ## Source 6: CRA Practice — Site Initiation Visit (SIV) Checklist **Reference:** `ICH GCP E6(R2) Sections 4.0-4.3, 5.6, 8.2 + Industry Best Practice` **Category:** Monitoring **Match Score:** 0.8065 PRACTICAL SIV CHECKLIST per ICH GCP: BEFORE SIV: - Protocol and all amendments approved by IRB - FDA 1572 signed by PI and filed - IRB roster and assurance on file - Financial disclosure forms completed - Clinical trial agreement signed - Investigator brochure available DURING SIV: 1. SITE STAFF: Verify PI qualifications (CV, license), staff training logs, delegation log 2. FACILITY: Inspect pharmacy (secure, temperature-controlled), lab (certifications), records storage (locked, limited access) 3. EQUIPMENT: Verify calibration of all equipment (centrifuge, freezer, thermometer, etc.) 4. IP: Review IP handling procedures, storage plan, accountability logs 5. REGULATORY: ICF version, IRB submission procedures, SAE reporting procedures 6. TRAINING: Conduct protocol training for all site staff, GCP training verification 7. SUBJECT RECRUITMENT: Review recruitment plan, screening procedures, advertising materials 8. MONITORING: Establish monitoring schedule, source document access, communication lines TRAINING MUST COVER: - Protocol requirements and visit schedule - ICF process and regulatory compliance - SAE reporting within 24 hours - IP handling and accountability - CRF completion guidelines - Data query process POST-SIV: Complete SIV report, file confirmation letter, submit to sponsor/CTM --- *Tip: Try rephrasing your question for more targeted matches.*