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Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - patient/subject file: Difference between revisions

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{{#set:
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|HasDocument=Document:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
|has_document=Document:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
|RefScope=HM
|module=4
|RefDocPart=Glossary - patient/subject file
|unit=4.2.1
|RefLanguage=EN
|scope=HM
|RefTagsEN=
|doc_part=Glossary - patient/subject file
|RefTagsOriginal=
|language=EN
|RefTagsFR=
|entry_by=Florian Adragna
|contributors=
|tags=TAG-00150-Sou-eUr ++ TAG-00244-Def-ini ++ TAG-00124-Cas-PrΓΌ ++ TAG-00025-Sub-mer
|tags_display=[[Glossary:TAG-00150-Sou-eUr|Source documents]], [[Glossary:TAG-00244-Def-ini|Definition]], [[Glossary:TAG-00124-Cas-PrΓΌ|Case report form]], [[Glossary:TAG-00025-Sub-mer|Trial participant]]
|comment=Definition of patient/subject file
|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.
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}}
{{:Document:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995}}
{| class="gplx-infobox"
|-
! colspan="2" class="gplx-infobox-header" | Reference Details
|-
! Scope
| HM
|-
! Document part
| Glossary - patient/subject file
|-
! Language
| EN
|-
! Original entry by
| Florian Adragna
|-
! Contributors
|
|-
! Tags (EN)
|
|-
! Tags (original language)
|
|-
! Tags (FR)
|
|-
! Comment
| Definition of patient/subject file
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== 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.

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 β€” 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.

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