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Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Overview of the Clinical Research Process: Difference between revisions

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{{#set:
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|HasDocument=Document:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005
|has_document=Document:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005
|RefScope=HM
|module=1
|RefDocPart=Overview of the Clinical Research Process
|unit=1.2.7
|RefLanguage=EN
|scope=HM
|RefTags=TAG-00033-Pro-oto ++ TAG-00151-Sta-rat ++ TAG-00137-Mon-che ++ TAG-00134-Eth-kom ++ TAG-00135-Inv-ntr ++ TAG-00341-Res-ben
|doc_part=Overview of the Clinical Research Process
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|entry_by=Florian Adragna
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|tags=TAG-00033-Pro-oto ++ TAG-00151-Sta-rat ++ TAG-00137-Mon-che ++ TAG-00134-Eth-kom ++ TAG-00135-Inv-ntr ++ TAG-00341-Res-ben
{{:Document:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005}}
|tags_display=[[Glossary:TAG-00033-Pro-oto|Protocol]], [[Glossary:TAG-00151-Sta-rat|SOP]], [[Glossary:TAG-00137-Mon-che|Monitoring]], [[Glossary:TAG-00134-Eth-kom|Ethics committee]], [[Glossary:TAG-00135-Inv-ntr|Trial site]], [[Glossary:TAG-00341-Res-ben|Responsibilities]]
 
|comment=Key trial activities: protocol, SOPs, monitoring, data management
{| class="wikitable gplx-infobox"
|content=Key trial activities include:
|-
! colspan="2" class="gplx-infobox-header" | Reference Details
|-
! Module
| Module 1 — Unit 1.2.7
|-
! Scope
| HM
|-
! Document part
| Overview of the Clinical Research Process
|-
! Language
| EN
|-
! Original entry by
| Florian Adragna
|-
! Contributors
|
|-
! Tags
| [[Glossary:TAG-00033-Pro-oto|Protocol]], [[Glossary:TAG-00151-Sta-rat|SOP]], [[Glossary:TAG-00137-Mon-che|Monitoring]], [[Glossary:TAG-00134-Eth-kom|Ethics committee]], [[Glossary:TAG-00135-Inv-ntr|Trial site]], [[Glossary:TAG-00341-Res-ben|Responsibilities]]
|-
! Comment
| Key trial activities: protocol, SOPs, monitoring, data management
|}
 
== Content ==
Key trial activities include:
1. Development of the trial protocol
1. Development of the trial protocol
[…]
[…]
Line 72: Line 42:
15. Reporting the trial
15. Reporting the trial
[…]
[…]
}}

Latest revision as of 13:49, 16 July 2026



Document information
Reference WHO WHO - HANDBOOK

FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005

Validity area WHO
Scope(s) HM
Document name WHO - HANDBOOK

FOR GOOD CLINICAL RESEARCH PRACTICE (GCP)

Version / Revision 2005
Status Current
Document type International guideline
Language(s) EN
Description HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) GUIDANCE FOR IMPLEMENTATION
Official source Official link
Restricted access No
Submitted by Florian Adragna
Contributors


Reference Details
Module Module 1 — Unit 1.2.7
Scope HM
Document part Overview of the Clinical Research Process
Language EN
Original entry by Florian Adragna
Contributors
Tags Protocol, SOP, Monitoring, Ethics committee, Trial site, Responsibilities

Content

Key trial activities include: 1. Development of the trial protocol […] 2. Development of standard operating procedures (SOPs) […] 3. Development of support systems and tools […] 4. Generation and approval of trial-related documents […] 5. Selection of trial sites and the selection of properly qualifi ed, trained, and experienced investigators and study personnel […] 6. Ethics committee review and approval of the protocol […] 7. Review by regulatory authorities […] 8. Enrollment of subjects into the study: recruitment, eligibility, and informed consent […] 9. The investigational product(s): quality, handling and accounting […] 10. Trial data acquisition: conducting the trial […] 11. Safety management and reporting […] 12. Monitoring the trial […] 13. Managing trial data […] 14. Quality assurance of the trial performance and data […] 15. Reporting the trial […]

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