FDA / ICH reference questions

**Fast regulation search** Searched the local FDA/ICH regulation database and found **6 matching sources** for: _How should CRF corrections be handled per ICH GCP?_ --- ## Q&A 1: 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. --- ## 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. --- ## Source 3: CRA Practice — Source Document Verification (SDV) Procedure **Reference:** `ICH GCP E6(R2) Section 5.18.4 + Industry Best Practice` **Category:** SDV **Match Score:** 0.3972 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 4: 4.9 — Source Data and Record Keeping **Reference:** `ICH GCP E6(R2) Section 4.9` **Category:** Data Management **Match Score:** 0.3754 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). --- ## Source 5: CRA Practice — How to Correct Source Data (ALCOA+) **Reference:** `ICH GCP E6(R2) Section 4.9 + ALCOA+ Principles` **Category:** SDV **Match Score:** 0.3427 ICH GCP 4.9 requires that changes to source data should be traceable, should not obscure the original entry, and should be explained if necessary. PRACTICAL PROCEDURE for source data correction: 1. Draw a SINGLE LINE through the incorrect entry so the original remains readable 2. Write the correct information clearly next to or above the error 3. Add the date of the correction 4. Initial the correction (the person making the correction signs their initials) 5. If needed, add a brief explanation (e.g., "erroneous entry" or "correction per source verification") 6. NEVER use correction fluid, white-out, erasers, or scribble over the original entry 7. NEVER use highlighters over incorrect data 8. For electronic records, corrections must be made via an audit trail that preserves the original entry 9. If the correction is made after the original entry date, a note should explain the delay CRAs should verify during SDV that all source data corrections follow these ALCOA+ principles. --- ## Q&A 6: 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. --- *Tip: Try rephrasing your question for more targeted matches.*