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Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - audit of a trial: 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 - audit of a trial
|unit=4.5.1
|RefLanguage=EN
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|RefTagsEN=
|doc_part=Glossary - audit of a trial
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|language=EN
|RefTagsFR=
|entry_by=Florian Adragna
|contributors=
|tags=TAG-00113-Aud-tQu ++ TAG-00244-Def-ini ++ TAG-00043-Goo-tek ++ TAG-00033-Pro-oto
|tags_display=[[Glossary:TAG-00113-Aud-tQu|Audit]], [[Glossary:TAG-00244-Def-ini|Definition]], [[Glossary:TAG-00043-Goo-tek|Good clinical practice]], [[Glossary:TAG-00033-Pro-oto|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.
}}
}}
{{:Document:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995}}
{| class="wikitable gplx-infobox"
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! colspan="2" class="gplx-infobox-header" | Reference Details
|-
! Scope
| HM
|-
! Document part
| Glossary - audit of a trial
|-
! Language
| EN
|-
! Original entry by
| Florian Adragna
|-
! Contributors
|
|-
! Tags (EN)
|
|-
! Tags (original language)
|
|-
! Tags (FR)
|
|-
! Comment
| Definition of audit (GCP/ICH)
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== 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.

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 4.5.1
Scope HM
Document part Glossary - audit of a trial
Language EN
Original entry by Florian Adragna
Contributors
Tags Audit, Definition, Good clinical practice, Protocol

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.

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