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

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 […]