FDA / ICH reference questions

**Fast regulation search** Searched the local FDA/ICH regulation database and found **6 matching sources** for: _What does 21 CFR Part 11 require for electronic signatures?_ --- ## Q&A 1: What is 21 CFR Part 11? **Category:** Regulatory **Source:** `FDA 21 CFR Part 11` **Answer:** FDA regulation defining criteria for electronic records and electronic signatures to be equivalent to paper records. Requires: system validation, audit trails, user authentication, secure signatures. --- ## Source 2: §11.1 — Scope **Reference:** `FDA 21 CFR Part 11 §11.1` **Category:** Electronic Records **Match Score:** 0.6754 §11.1 (a) This part applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any records requirements set forth in Agency regulations. This part also applies to electronic signatures submitted to the Agency. (b) This part does not apply to paper records that are, or have been, transmitted by electronic means. (c) This part applies to persons who use electronic records or signatures in lieu of paper records. (d) This part does not apply to records required by the following: (1) Records applicable to clinical investigations regulated by part 312 of this chapter (Investigational New Drug Application). --- ## Source 3: §11.70 — Signature/Record Linking **Reference:** `FDA 21 CFR Part 11 §11.70` **Category:** Electronic Signatures **Match Score:** 0.4442 §11.70 Electronic signatures and handwritten signatures executed to electronic records shall be linked to their respective electronic records to ensure that the signatures cannot be excised, copied, or otherwise transferred to falsify an electronic record by ordinary means. --- ## Q&A 4: What is EDC? **Category:** Data Management **Source:** `21 CFR Part 11` **Answer:** Electronic Data Capture system for clinical data. Must comply with 21 CFR Part 11: audit trails, authentication, secure access, e-signatures. Examples: Medidata Rave, Veeva Vault, REDCap. --- ## Q&A 5: What are Essential Documents per ICH GCP Section 8? **Category:** Documentation **Source:** `ICH GCP Section 8` **Answer:** Documents permitting evaluation of trial conduct and data quality. Filed in TMF: Before Phase (protocol, IB, ICF, IRB approval, 1572), During Phase (CRFs, source docs, AE reports), After Phase (datasets, audit certificates). --- ## Source 6: CRA Practice — Source Document Verification (SDV) Procedure **Reference:** `ICH GCP E6(R2) Section 5.18.4 + Industry Best Practice` **Category:** SDV **Match Score:** 0.3503 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 --- *Tip: Try rephrasing your question for more targeted matches.*