View source for Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Overview of the Clinical Research Process

{{#set:
|HasDocument=Document:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005
|RefScope=HM
|RefDocPart=Overview of the Clinical Research Process
|RefLanguage=EN
|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
|RefModule=1
|RefUnit=1.2.7
}}

{{:Document:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005}}

{| class="wikitable gplx-infobox"
|-
! 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
[…]
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
[…]