GCP Inspectors Working Group

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The GCP Inspectors Working Group focuses on harmonisation and co-ordination of GCP related activities at Community level. The Group activities are outlined in its work plan. It is involved in the preparation of new and revised guidance on GCP and community procedures relating to inspection. The Sector chairs and provides secretarial support to the GCP Inspectors Working Group. Members provide the expertise for the fulfillment of the group tasks and play a key role in the development of collaborative projects both within the community and externally.

The GCP Inspectors Working Group meets on a regular basis four times a year, at the European Medicines Agency with representatives of the GCP inspectorates of the European Economic Area Member States, observers from candidate countries and Switzerland.

They support the co-ordination of the provision of GCP advice and provide a link with other groups such as CHMP, CVMP, EWP and PhVWP.  These links include joint meetings with clinical and pharmacovigilance assessors and contributions to training of both inspectors and assessors. The Mandate of the GCP Inspectors Working Group describes the group's role and activities in more detail.

The GCP Inspectors maintain a dialogue with GMP Inspectors on areas of common interest in particular the interface between GMP for investigational medicinal products and GCP. A GCP / GMP subgroup assists in the interpretation of GMP in a number of specified areas (see workplan).

Send all queries regarding this content to: gcp@ema.europa.eu.

Documents of interest

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Document(s) Language Status First published Last updated Effective Date
Workshop on risk-based quality management in clinical trials 2-3 December 2013: Summaries of the presentations (English only)   07/07/2014    
Annual report of the Good Clinical Practice Inspectors Working Group 2013 (English only) adopted 16/06/2014    
Work plan for Good Clinical Practice Inspectors Working Group 2014 (English only) adopted 25/02/2014    
Overview of comments received on 'Reflection paper on the use of interactive response technologies (interactive voice/web response systems) in clinical trials' (English only)   21/02/2014    
Minutes of Joint meeting of Good-clinical-practice compliance Inspectors Working Group and eClinical Forum representatives on electronic data capture systems and investigator site eSource readiness (English only) adopted 10/01/2014    
Reflection paper on the use of interactive response technologies (interactive voice/web response systems) in clinical trials, with particular emphasis on the handling of expiry dates (English only) adopted 18/12/2013   18/12/2013
Reflection paper on risk based quality management in clinical trials (English only) adopted 22/11/2013   22/11/2013
Points to consider for assessors, inspectors and European Medicines Agency inspection coordinators on the identification of triggers for the selection of applications for 'routine' and 'for-cause' inspections, their investigation and the scope of such inspections (English only) adopted 20/08/2013   20/08/2013
Annual report of the Good Clinical Practice Inspectors Working Group 2012 (English only) adopted 14/06/2013    
Reflection paper on good-clinical-practice compliance in relation to trial master files (paper and / or electronic) for management, audit and inspection of clinical trials (English only) draft: consultation closed 18/02/2013    
Points to consider on good-clinical-practice inspection findings and the benefit-risk balance (English only) adopted 29/01/2013    
Work plan for Good Clinical Practice Inspectors Working Group 2013 (English only) adopted 29/01/2013    
Annual report of the Good Clinical Practice Inspections Working Group 2011 (English only) adopted 17/07/2012    
Annual report of the Good Clinical Practice Inspections Working Group 2010 (English only) adopted 17/07/2012    
Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples (English only) adopted 20/03/2012   20/03/2012
Work plan for the Good Clinical Practice Inspectors Working Group for 2012 (English only) adopted 20/02/2012    
Reflection paper on the use of interactive response technologies (interactive voice/web response systems) in clinical trials (English only) draft: consultation closed 11/08/2011    
Reflection paper on risk-based quality management in clinical trials (English only) draft: consultation closed 05/08/2011    
Workplan for Good Clinical Practice Inspectors Working Group (GCP IWG) for 2011 (English only) adopted 15/03/2011    
Workplan for Good Clinical Practice Inspectors Working Group (GCP IWG) for 2010 (English only) adopted 05/02/2010    
Work plan for Good Clinical Practice Inspectors Working Group (GCP IWG) for 2009 (English only) adopted 18/03/2009    
Work plan for Good Clinical Practice inspectors Working Group (GCP IWG) for 2008 (English only) adopted 12/08/2008    
Annual report of the good clinical practice inspections working group 2009 (English only) adopted 22/03/2010    
Annual report of the good clinical practice inspectors working group 2008 (English only) adopted 18/05/2009    
Overview of comments received on 'reflection paper on guidance for laboratories that perform the analysis or evaluation of clinical samples' (English only)   17/02/2012    
Draft reflection paper on guidance for laboratories that perform the analysis or evaluation of clinical trial samples (English only) draft: consultation closed 23/09/2010    
Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials (English only) adopted 12/08/2010   01/08/2010
Reflection paper on advice to applicants/sponsors/CROS of bioequivalence studies (English only) adopted 19/09/2008    
Draft reflection paper on expectations for electronic source documents used in clinical trials (English only) draft: consultation closed 17/10/2007    
Mandate, objectives and rules of procedure for the GCP Inspectors Working Group (GCP IWG) (English only) adopted 27/07/2007 27/11/2013