APEC Publications | 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

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

PUBLICATION NUMBER
APEC#208-CT-04.3
YEAR
2008
PUBLISHED DATE
May 2008
TYPE OF PUBLICATION
Proceedings
PAGES
372
ACCESSED
2038

 

Individual Files

  • Part I. Background
  • Part II. Presentations
  • Part III. Round Table Discussion:
  • Part IV. Participants
  • Part V. Questionnaire Survey Results



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.




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File size: 4776.37KB



INDIVIDUAL FILES

Individual Files

  • Part I. Background
  • Part II. Presentations
  • Part III. Round Table Discussion:
  • Part IV. Participants
  • Part V. Questionnaire Survey Results


DESCRIPTIONS

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.

DOWNLOAD

Download

File size: 4776.37KB


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