Reference:WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005 Overview of the Clinical Research Process
From GxPlex
| 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 […]
