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.

MHRA Stakeholder Engagement Meeting (StEM)

Paul Strickland, Chair of the EFGCP Audit Working Party, attended the MHRA Stakeholder Engagement Meeting (StEM) on the 18th March 2016 to represent the EFGCP. The MHRA meet approximately annually with invited stakeholders to discuss issues of concern from both sides.

EFGCP stakeholders raised the issues of Trial Master Files and electronic PROs, which were addressed by presentations from the inspectors. The MHRA raised the issue of Reference Safety Information as they are seeing many misunderstandings in this area and have written numerous findings for inspected parties, both in the commercial and non-commercial areas. The meeting was collaborative, with the inspectors responding to further discussion from the stakeholders.

Notice will be given before the next MHRA StEM and a request for topics sent across the Forum.

 

01_StEM_MHRA Update_March2016

 

02_StEM_TMF Presentation_March 2016

 

03_StEM_ePRO MHRA Case Study_March2016

 

04_StEM_RSI_March 2016

 


 

Documents & Latest publications

Notes on Clinical Trial Insurance Issues (2010)

 

The Role of the Quality Assurance Unit (2008)

 

Revision of the ENGAGE Auditing Guideline (2005)

 

Guideline for Auditing Clinical Laboratories (2005)

 

 

Contact

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


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