Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - audit of a trial
From GxPlex
| Document information | |
|---|---|
| Reference | WHO WHO - Guidelines for GCP for trials on
pharmaceutical products* 1995 |
| Validity area | WHO |
| Scope(s) | HM |
| Document name | WHO - Guidelines for GCP for trials on
pharmaceutical products* |
| Version / Revision | 1995 |
| Status | Current |
| Document type | International guideline |
| Language(s) | EN |
| Description | World Health Organization
WHO Technical Report Series, No. 850, 1995, Annex 3 Guidelines for good clinical practice (GCP) for trials on pharmaceutical products* |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 4 â Unit 4.5.1 |
| Scope | HM |
| Document part | Glossary - audit of a trial |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Audit, Definition, Good clinical practice, Protocol |
| Comment | Definition of audit (GCP/ICH) |
Content
audit of a trial A systematic examination, carried out independently of those directly involved in the trial, to determine whether the conduct of a trial complies with the agreed protocol and whether the data reported are consistent with the records on site, e.g. whether data reported or recorded in the case-report forms (CRFs) are consonant with those found in hospital files and other original records.
