audit
- Guideline or reference source
- CDISC Glossary of terms
- ICHE6(r1) Guideline for good clinical practice
- Definition
- A systematic and independent examination of trial related activities and documents to determine whether the evaluated trial related activities were conducted, and the data were recorded, analyzed and accurately reported according to the protocol, sponsor's standard operating procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).
- Narrower Term
- process audit
- system audit
- Related Term
- audit certificate
- audit findings
- audit report
- audit trail
- auditors
- inspection
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