Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - raw data: Difference between revisions
From GxPlex
Gxplex admin (talk | contribs) m 1 revision imported |
imported>GxPlexBot Import from GxPlex Excel |
||
| Line 4: | Line 4: | ||
|RefDocPart=Glossary - raw data | |RefDocPart=Glossary - raw data | ||
|RefLanguage=EN | |RefLanguage=EN | ||
| | |RefTags=TAG-00150-Sou-eUr ++ TAG-00244-Def-ini ++ TAG-00100-Lab-bor | ||
| | |RefModule=4 | ||
| | |RefUnit=4.2.1 | ||
}} | }} | ||
| Line 14: | Line 14: | ||
|- | |- | ||
! colspan="2" class="gplx-infobox-header" | Reference Details | ! colspan="2" class="gplx-infobox-header" | Reference Details | ||
|- | |||
! Module | |||
| Module 4 — Unit 4.2.1 | |||
|- | |- | ||
! Scope | ! Scope | ||
| Line 30: | Line 33: | ||
| | | | ||
|- | |- | ||
! Tags | ! Tags | ||
| | | [[Glossary:TAG-00150-Sou-eUr|Source documents]], [[Glossary:TAG-00244-Def-ini|Definition]], [[Glossary:TAG-00100-Lab-bor|Laboratory]] | ||
|- | |||
|- | |||
| | |||
|- | |- | ||
! Comment | ! Comment | ||
Revision as of 17:29, 15 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 - raw data |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Source documents, Definition, Laboratory |
| Comment | Definition of raw data |
Content
raw data All records or certified copies of original observations, clinical findings or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Such material includes laboratory notes, memoranda, calculations and documents, as well as all records of data from automated instruments or exact, verified copies in the form of photocopies, microfiches etc. Raw data can also include photographic negatives, microfilm or magnetic media (e.g. computer diskettes).
