FDA / ICH reference questions

**Fast regulation search** Searched the local FDA/ICH regulation database and found **7 matching sources** for: _What are the requirements for source data under ICH GCP?_ --- ## Q&A 1: What are the requirements for source data under ICH GCP? **Category:** Data Management **Source:** `ICH GCP E6(R2) Section 4.9` **Answer:** ICH GCP 4.9 requires the investigator/institution to maintain adequate and accurate source documents and trial records containing all pertinent subject observations. Source data should be attributable, legible, contemporaneous, original, accurate, and complete. Corrections must be traceable, must not obscure the original entry, and should be explained when needed. For a CRA, this means verifying that source supports CRF data, corrections preserve an audit trail, and records are complete, current, and available for monitoring/audit/inspection. --- ## Q&A 2: What is ALCOA+? **Category:** Data Integrity **Source:** `FDA Guidance, ICH GCP 4.9` **Answer:** A-Attributable, L-Legible, C-Contemporaneous, O-Original, A-Accurate. + Complete, Consistent, Enduring, Available. These are the principles for source data quality per FDA guidance and ICH GCP 4.9. --- ## Q&A 3: How should source data corrections be made? **Category:** Data Integrity **Source:** `ICH GCP 4.9, ALCOA+` **Answer:** Per ALCOA+: single line through error (original visible), write correction nearby, add date, initial, add explanation if needed. NEVER white-out/eraser. EDC audit trail preserves original. --- ## Source 4: 4.9 — Source Data and Record Keeping **Reference:** `ICH GCP E6(R2) Section 4.9` **Category:** Data Management **Match Score:** 0.6163 4.9.0 The investigator/institution should maintain adequate and accurate source documents and trial records that include all pertinent observations on each of the trial's subjects. Source data should be attributable, legible, contemporaneous, original, accurate, and complete. Changes to source data should be traceable, should not obscure the original entry, and should be explained if necessary (e.g., via an audit trail). --- ## Q&A 5: 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. --- ## Q&A 6: What is ICH GCP E6(R2)? **Category:** GCP Basics **Source:** `ICH E6(R2) Guideline` **Answer:** ICH GCP E6(R2) is the International Council for Harmonisation guideline for Good Clinical Practice. R2 (2016 addendum) emphasizes Risk-Based Monitoring, source data verification, and quality management in clinical trials. --- ## Source 7: CRA Practice — Source Document Verification (SDV) Procedure **Reference:** `ICH GCP E6(R2) Section 5.18.4 + Industry Best Practice` **Category:** SDV **Match Score:** 0.4568 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.*