Basic Workshop on Good Clinical Practice (GCP)/ Clinical Research Inspection, May 2008
| Published Date | May 2008 |
|---|---|
| Type of Publication | Proceedings |
| Publication Under | CTI Sub-Fora & Industry Dialogues Groups, Life Sciences Innovation Forum (LSIF) |
| Accessed | 7436 |
| Pages | 372 |
| Download publication | Download |
Description
(Reproduced electronically in August 2008). The workshop provided training presentations, exercises and discussion opportunities according to clinical trial inspection and regulations. The main topics were Roles and Responsibilities under GCP, Elements of Data Quality and Integrity, Introduction to GCP Inspection Techniques and Documentation, Inspecting at a Clinical Investigator Site Including On-site Exercise, Compliance and Enforcement Tools, and Introduction to the Inspection of Sponsors/Contract Research Organizations and Independent Ethics Committees.
- Part I. Background
- Part II. Presentations
- Part III. Round Table Discussion:
- Part IV. Participants
- Part V. Questionnaire Survey Results