Good Clinical Practice Inspectors Working Group
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 four times a year, at EMA, 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).
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EMA GCP IWG points to consider regarding the management of ongoing clinical trials impacted by political conflicts, natural disasters or other (PDF/165.96 KB)
First published: 05/04/2023
EMA/INS/GCP/622198/2022 -
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Guideline on computerised systems and electronic data in clinical trials (PDF/701.75 KB)
Adopted
First published: 10/03/2023
EMA/INS/GCP/112288/2023 -
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Draft guideline on computerised systems and electronic data in clinical trials (PDF/573.2 KB)
Draft: consultation closed
First published: 18/06/2021
Consultation dates: 18/06/2021 to 17/12/2021
EMA/226170/2021 -
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Annual Report of the Good Clinical Practice Inspectors' Working Group 2021 (PDF/409.25 KB)
Adopted
First published: 21/11/2022
EMA/INS/GCP/33934/2022 -
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Annual Report of the Good Clinical Practice Inspectors' Working Group 2020 (PDF/429.31 KB)
Adopted
First published: 20/05/2022
EMA/INS/GCP/271107/2022 -
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Work Plan 2021-2023 of the Good Clinical Practice Inspectors Working Group (GCP IWG) (PDF/242.75 KB)
First published: 10/02/2022
EMA/INS/GCP/452875/2020 -
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Annual Report of the Good Clinical Practice Inspectors Working Group 2019 (PDF/464.89 KB)
Adopted
First published: 10/02/2022
EMA/INS/GCP/588463/2020 -
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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 (PDF/378.22 KB)
Adopted
First published: 04/02/2022
Last updated: 05/04/2023
EMA/151704/2023 (replacing EMA/803916/2022 for the first page disclaimer only) -
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Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol (PDF/605.86 KB)
Adopted
First published: 17/12/2021
EMA/698382/2021 -
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Appendix III b – Information to be submitted with a notification of a serious breach - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol (DOCX/129.92 KB)
First published: 17/12/2021 -
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Notice to sponsors on validation and qualification of computerised systems used in clinical trials (PDF/119.59 KB)
First published: 15/04/2020
EMA/INS/GCP/467532/2019 -
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Annual report of the Good Clinical Practice Inspectors' Working Group 2018 (PDF/445.43 KB)
Adopted
First published: 14/05/2020
EMA/INS/GCP/819744/2018 -
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Work Plan 2020 of the Good Clinical Practice Inspectors' Working Group (PDF/219.25 KB)
Adopted
First published: 12/05/2020
EMA/INS/GCP/637644 /2019 -
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Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) (PDF/163.81 KB)
Adopted
First published: 18/12/2018
Legal effective date: 18/06/2019
EMA/INS/GCP/856758/2018 -
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Draft guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with good clinical practice and good manufacturing practice (PDF/116.83 KB)
Draft: consultation closed
First published: 23/05/2018
Last updated: 23/05/2018
Consultation dates: 23/05/2018 to 31/08/2018
EMA/202679/2018 -
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Final summary record – EDC systems and risk-based monitoring in Clinical Trials (PDF/150.39 KB)
Adopted
First published: 26/06/2017
Last updated: 26/06/2017
EMA/729273/2016 -
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Draft guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol (PDF/165.39 KB)
Draft: consultation closed
First published: 23/05/2017
Last updated: 23/05/2017
Consultation dates: 23/05/2017 to 22/08/2017
EMA/430909/2016 -
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Draft guideline on good -clinical -practice compliance in relation to trial master file (paper and/or electronic) for content, management, archiving, audit and inspection of clinical trials (PDF/183.56 KB)
Draft: consultation closed
First published: 12/04/2017
Last updated: 12/04/2017
Consultation dates: 12/04/2017 to 11/07/2017
EMA/15975/2016 -
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Classification and analysis of the good clinical practice (GCP) inspection findings of GCP inspections conducted at the request of CHMP (PDF/1.23 MB)
First published: 08/12/2014
Last updated: 08/12/2014
INS/GCP/46309/2012 -
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Workshop on risk-based quality management in clinical trials 2-3 December 2013: Summaries of the presentations (PDF/97.17 KB)
First published: 07/07/2014
Last updated: 07/07/2014
EMA/84016/2014 -
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Overview of comments received on 'Reflection paper on the use of interactive response technologies (interactive voice/web response systems) in clinical trials' (PDF/659.08 KB)
First published: 21/02/2014
Last updated: 21/02/2014
EMA/INS/GCP/100058/2012 -
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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 (PDF/86.56 KB)
Adopted
First published: 10/01/2014
Last updated: 10/01/2014
EMA/INS/GCP/504197/2013 -
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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 (superseded) (PDF/247.44 KB)
Adopted
First published: 18/12/2013
Last updated: 04/02/2022
Legal effective date: 18/12/2013
EMA/INS/GCP/600788/2011 -
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Reflection paper on risk based quality management in clinical trials (PDF/251.05 KB)
Adopted
First published: 22/11/2013
Last updated: 22/11/2013
Legal effective date: 22/11/2013
EMA/269011/2013 -
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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 inve... (PDF/139.4 KB)
Adopted
First published: 20/08/2013
Last updated: 20/08/2013
Legal effective date: 20/08/2013
EMA/INS/GCP/167386/2012 -
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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 (PDF/188.15 KB)
Draft: consultation closed
First published: 18/02/2013
Last updated: 17/06/2015
Consultation dates: 01/02/2013 to 30/04/2013
EMA/INS/GCP/636736/2012 -
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Points to consider on good-clinical-practice inspection findings and the benefit-risk balance (PDF/136.5 KB)
Adopted
First published: 29/01/2013
Last updated: 29/01/2013
EMA/868942/2011 -
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Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples (PDF/135.03 KB)
Adopted
First published: 20/03/2012
Last updated: 20/03/2012
Legal effective date: 20/03/2012
EMA/INS/GCP/532137/2010 -
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Overview of comments received on 'reflection paper on guidance for laboratories that perform the analysis or evaluation of clinical samples' (PDF/513.73 KB)
First published: 17/02/2012
Last updated: 17/02/2012
EMA/INS/GCP/219642/2011 -
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Reflection paper on the use of interactive response technologies (interactive voice/web response systems) in clinical trials (PDF/126.72 KB)
Draft: consultation closed
First published: 11/08/2011
EMA/803916/2022 -
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Reflection paper on risk-based quality management in clinical trials (PDF/231.81 KB)
Draft: consultation closed
First published: 05/08/2011
Last updated: 05/08/2011
Consultation dates: 15/06/2011 to 15/02/2012
EMA/INS/GCP/394194/2011 -
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Draft reflection paper on guidance for laboratories that perform the analysis or evaluation of clinical trial samples (PDF/176.45 KB)
Draft: consultation closed
First published: 23/09/2010
Last updated: 23/09/2010
Consultation dates: 10/06/2010 to 28/02/2011
EMA/INS/GCP/532137/2010 -
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Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials (superseded) (PDF/709.59 KB)
Adopted
First published: 12/08/2010
Last updated: 12/08/2010
Legal effective date: 01/08/2010
EMA/INS/GCP/454280/2010 -
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Reflection paper on advice to applicants/sponsors/CROS of bioequivalence studies (PDF/103.63 KB)
Adopted
First published: 19/09/2008
Last updated: 19/09/2008
EMEA/INS/GCP/468975/2007 -
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Draft reflection paper on expectations for electronic source documents used in clinical trials (PDF/95.3 KB)
Draft: consultation closed
First published: 17/10/2007
Last updated: 17/10/2007
EMEA/505620/2007 -
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Mandate, objectives and rules of procedure for the GCP Inspectors Working Group (GCP IWG) (PDF/109.74 KB)
Adopted
First published: 27/07/2007
Last updated: 27/11/2013
EMA/INS/GCP/285522/2013
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Work plan for Good Clinical Practice Inspectors Working Group 2018 (PDF/150.59 KB)
Adopted
First published: 22/03/2018
Last updated: 22/03/2018
EMA/87812 /2018 -
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Annual report of the Good Clinical Practice Inspectors' Working Group 2017 (PDF/455.35 KB)
Adopted
First published: 27/11/2018
EMA/INS/GCP/779632/2017 -
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Work plan for Good Clinical Practice (GCP) Inspectors Working Group for 2017 (PDF/98.13 KB)
Adopted
First published: 21/02/2017
Last updated: 21/02/2017
EMA/INS/GCP/13279/2017 -
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Annual report of the Good Clinical Practice Inspectors Working Group 2016 (PDF/299.38 KB)
Adopted
First published: 18/08/2017
Last updated: 18/08/2017
EMA/INS/GCP/763873/2016 -
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Work plan for Good Clinical Practice Inspectors Working Group 2016 (PDF/101.82 KB)
First published: 26/02/2016
Last updated: 26/02/2016
EMA/INS/GCP/752886/2015 -
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Annual report of the Good Clinical Practice Inspections Working Group 2015 (PDF/290.84 KB)
Adopted
First published: 01/08/2016
Last updated: 01/08/2016
EMA/INS/GCP/137204/2016 -
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Work plan for Good Clinical Practice Inspectors Working Group 2015 (PDF/153.45 KB)
Adopted
First published: 06/03/2015
Last updated: 06/03/2015
EMA/INS/GCP/434364/2014 -
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Annual report of the Good Clinical Practice Inspections Working Group 2014 (PDF/288.15 KB)
Adopted
First published: 03/07/2015
Last updated: 03/07/2015
EMA/INS/GCP/434373/2014 -
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Work plan for Good Clinical Practice Inspectors Working Group 2014 (PDF/102.15 KB)
Adopted
First published: 25/02/2014
Last updated: 25/02/2014
EMA/INS/GCP/554674/2013 -
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Annual report of the Good Clinical Practice Inspectors Working Group 2013 (PDF/301.85 KB)
Adopted
First published: 16/06/2014
Last updated: 16/06/2014
EMA/INS/GCP/123295/2013 -
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Work plan for Good Clinical Practice Inspectors Working Group 2013 (PDF/91.35 KB)
Adopted
First published: 29/01/2013
Last updated: 29/01/2013
EMA/569405/2012 -
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Annual report of the Good Clinical Practice Inspectors Working Group 2012 (PDF/238.98 KB)
Adopted
First published: 14/06/2013
Last updated: 14/06/2013
EMA/627138/2012 -
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Work plan for the Good Clinical Practice Inspectors Working Group for 2012 (PDF/72.29 KB)
Adopted
First published: 20/02/2012
Last updated: 20/02/2012
EMA/INS/GCP/920415/2011 -
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Annual report of the Good Clinical Practice Inspections Working Group 2011 (PDF/220.72 KB)
Adopted
First published: 17/07/2012
Last updated: 17/07/2012
EMA/INS/GCP/972336/2011 -
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Workplan for Good Clinical Practice Inspectors Working Group (GCP IWG) for 2011 (PDF/96.75 KB)
Adopted
First published: 15/03/2011
Last updated: 15/03/2011
EMA/INS/GCP/711390/2010 -
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Annual report of the Good Clinical Practice Inspections Working Group 2010 (PDF/210.32 KB)
Adopted
First published: 17/07/2012
Last updated: 17/07/2012
EMA/INS/GCP/711391/2010 -
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Workplan for Good Clinical Practice Inspectors Working Group (GCP IWG) for 2010 (PDF/89.82 KB)
Adopted
First published: 05/02/2010
Last updated: 05/02/2010
EMA/INS/GCP/782669/2009 -
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Work plan for Good Clinical Practice Inspectors Working Group (GCP IWG) for 2009 (PDF/83.79 KB)
Adopted
First published: 18/03/2009
Last updated: 18/03/2009
EMEA/INS/GCP/449289/2008 -
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Annual report of the good clinical practice inspections working group 2009 (PDF/240.96 KB)
Adopted
First published: 22/03/2010
Last updated: 22/03/2010
EMA/INS/GCP/782679/2009 -
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Work plan for Good Clinical Practice inspectors Working Group (GCP IWG) for 2008 (PDF/54.67 KB)
Adopted
First published: 12/08/2008
Last updated: 12/08/2008
EMEA/INS/GCP/546619/2007 -
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Annual report of the good clinical practice inspectors working group 2008 (PDF/105.43 KB)
Adopted
First published: 18/05/2009
Last updated: 18/05/2009
EMEA/INS/GCP/594196/2008