GUIDANCE Final
Guideline on Computerised Systems and Electronic Data in Clinical Trials
ABSTRACT — EDITORS' SUMMARY
Operational expansion of E6(R3) §4.3. Covers BYOD, segregation of duties, ALCOA++, and cloud taxonomy. The most prescriptive document on computerised systems in the global GCP landscape.
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PDF · CANONICAL LINK https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf ↗ RELATED · SAME AUTHORITY