Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - protocol: Difference between revisions
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| | |has_document=Document:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 | ||
| | |module=2 | ||
| | |unit=2.1.3 | ||
| | |scope=HM | ||
| | |doc_part=Glossary - protocol | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
|contributors= | |||
|tags=TAG-00033-Pro-oto ++ TAG-00244-Def-ini ++ TAG-00338-Met-odi ++ TAG-00317-Obj-set | |||
|tags_display=[[Glossary:TAG-00033-Pro-oto|Protocol]], [[Glossary:TAG-00244-Def-ini|Definition]], [[Glossary:TAG-00338-Met-odi|Methodology]], [[Glossary:TAG-00317-Obj-set|Objective]] | |||
|comment=Definition of trial protocol | |||
|content=protocol | |||
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protocol | |||
A document which states the background, rationale and objectives of the trial and describes its design, methodology and organization, including statistical considerations, and the conditions under which it is to be performed and managed. The protocol should be dated and signed by the investigator, the institution involved and the sponsor. It can also function as a contract. | A document which states the background, rationale and objectives of the trial and describes its design, methodology and organization, including statistical considerations, and the conditions under which it is to be performed and managed. The protocol should be dated and signed by the investigator, the institution involved and the sponsor. It can also function as a contract. | ||
}} | |||
Latest revision as of 13:49, 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 2 — Unit 2.1.3 |
| Scope | HM |
| Document part | Glossary - protocol |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Protocol, Definition, Methodology, Objective |
Content
protocol
A document which states the background, rationale and objectives of the trial and describes its design, methodology and organization, including statistical considerations, and the conditions under which it is to be performed and managed. The protocol should be dated and signed by the investigator, the institution involved and the sponsor. It can also function as a contract.
