Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - patient/subject file: Difference between revisions
From GxPlex
Migrate to Template:ReferenceData for PageForms (GxPlexBot) |
Gxplex admin (talk | contribs) m 1 revision imported |
(No difference)
| |
Latest revision as of 13:50, 16 July 2026
| 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 — Unit 4.2.1 |
| Scope | HM |
| Document part | Glossary - patient/subject file |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Source documents, Definition, Case report form, Trial participant |
Content
patient/subject file A collection of data consisting of all relevant information on the patient or subject (such as hospital file, consultation records or special subject file) that permits the authenticity of the information presented in case-record forms to be verified and, where necessary, completed or corrected. The conditions regulating the use and consultation of such documents must be respected.
