EFGCP Audit Working Party

The Audit Working Party examines ethical, safety, and data oversight issues in clinical research. Its primary focus is on the work of the professional clinical trial auditor, with a view toward the regulatory and legal issues that distinguish this expertise. The Audit Working Party also looks at issues related to clinical trial monitoring and inspection. It is particularly concerned with the development of European standards for monitoring clinical trials, ethics committees, and sponsor-related responsibilities. It provides a framework for considering the impact and development of a European clinical trials inspection system within the context of sponsor, investigator, and ethics committee responsibilities.

Documents & Latest publications

Notes on Clinical Trial Insurance Issues (2009)

The Role of the Quality Assurance Unit (2008)

Revision of the ENGAGE Auditing Guideline (2005)

Guideline for Auditing Clinical Laboratories (2005)

Contact

Paul Strickland
EFGCP Secretariat
Square de Meeûs
Rue de l'Industrie 4
B-1000 Brussels
Belgium
Tel +32 (0)2 732 87 83
Tel + 44 (0)1223 420305 (work)
Fax + 44 (0)1223 228102 (work)
E-mail: paul.strickland@efgcp.eu