Basic Workshop on Good Clinical Practice (GCP)/ Clinical Research Inspection, May 2008

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Basic Workshop on Good Clinical Practice (GCP)/ Clinical Research Inspection, May 2008

Publication Number

APEC#208-CT-04.3

Published Date

May 2008

Type of Publication

Proceedings

Publications Under

CTI Sub-Fora & Industry Dialogues Groups, Life Sciences Innovation Forum(LSIF)

Accessed

2106

Pages

372

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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