Good Clinical Practice Inspectors Working Group

HumanCompliance and inspectionsRegulatory and procedural guidanceResearch and development

The GCP Inspectors Working Group focuses on harmonisation and co-ordination of GCP related activities at Community level. It is involved in the preparation of new and revised guidance on GCP and community procedures relating to inspection.

Members provide the expertise for the fulfilment of the group tasks and play a key role in the development of collaborative projects both within the community and externally.

They support the co-ordination of the provision of GCP advice and provide a link with other groups such as CHMP, CVMP, CMDh, CTCG, PhV IWG, GMDP IWG. These links include joint meetings with clinical assessors and contributions to training of both inspectors and assessors.

The GCP IWG meets four times a year, with representatives of the GCP inspectorates of the European Economic Area Member States and the European Commission, observers from pre-accession countries, Switzerland and WHO. The Inspections Office chairs and provides secretarial support to the GCP IWG. The Mandate, objectives and rules of procedure for the GCP IWG describes the group's role and activities in more detail and the GCP IWG’s activities are outlined in its work plan; both documents can be consulted below.

2024-2026 Work Plan of the Good Clinical Practice Inspectors Working Group (GCP IWG)

Reference Number: EMA/INS/GCP/329215/2023 Rev.1

English (EN) (347.31 KB - PDF)

First published: 21/12/2023Last updated: 17/03/2025

Mandate, objectives and rules of procedure for the GCP Inspectors Working Group (GCP IWG)

AdoptedReference Number: EMA/INS/GCP/285522/2013

English (EN) (109.74 KB - PDF)

First published: 27/07/2007Last updated: 27/11/2013

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2024-2026 Work Plan of the Good Clinical Practice Inspectors Working Group (GCP IWG)

Reference Number: EMA/INS/GCP/329215/2023 Rev.1

English (EN) (347.31 KB - PDF)

First published: 21/12/2023Last updated: 17/03/2025

Work Plan 2021-2023 of the Good Clinical Practice Inspectors Working Group (GCP IWG)

Reference Number: EMA/INS/GCP/452875/2020

English (EN) (242.75 KB - PDF)

First published: 10/02/2022

Work Plan 2020 of the Good Clinical Practice Inspectors' Working Group

AdoptedReference Number: EMA/INS/GCP/637644 /2019

English (EN) (219.25 KB - PDF)

First published: 12/05/2020

Work plan for Good Clinical Practice Inspectors Working Group 2018

AdoptedReference Number: EMA/87812 /2018

English (EN) (150.59 KB - PDF)

First published: 22/03/2018Last updated: 22/03/2018

Work plan for Good Clinical Practice (GCP) Inspectors Working Group for 2017

AdoptedReference Number: EMA/INS/GCP/13279/2017

English (EN) (98.13 KB - PDF)

First published: 21/02/2017Last updated: 21/02/2017

Work plan for Good Clinical Practice Inspectors Working Group 2016

Reference Number: EMA/INS/GCP/752886/2015

English (EN) (101.82 KB - PDF)

First published: 26/02/2016Last updated: 26/02/2016

Work plan for Good Clinical Practice Inspectors Working Group 2015

AdoptedReference Number: EMA/INS/GCP/434364/2014

English (EN) (153.45 KB - PDF)

First published: 06/03/2015Last updated: 06/03/2015

Work plan for Good Clinical Practice Inspectors Working Group 2014

AdoptedReference Number: EMA/INS/GCP/554674/2013Summary:

The Good Clinical Practice Inspectors Working Group (GCP IWG) was established by the European Medicines Agency (EMA) in 1997, within the scope of article 57(1)(i) of Regulation (EC) No 726/2004. This group focuses on harmonisation and co-ordination of GCP related activities at a European level.

English (EN) (102.15 KB - PDF)

First published: 25/02/2014Last updated: 25/02/2014

Work plan for Good Clinical Practice Inspectors Working Group 2013

AdoptedReference Number: EMA/569405/2012

English (EN) (91.35 KB - PDF)

First published: 29/01/2013Last updated: 29/01/2013

Work plan for the Good Clinical Practice Inspectors Working Group for 2012

AdoptedReference Number: EMA/INS/GCP/920415/2011

English (EN) (72.29 KB - PDF)

First published: 20/02/2012Last updated: 20/02/2012

Workplan for Good Clinical Practice Inspectors Working Group (GCP IWG) for 2011

AdoptedReference Number: EMA/INS/GCP/711390/2010

English (EN) (96.75 KB - PDF)

First published: 15/03/2011Last updated: 15/03/2011

Workplan for Good Clinical Practice Inspectors Working Group (GCP IWG) for 2010

AdoptedReference Number: EMA/INS/GCP/782669/2009

English (EN) (89.82 KB - PDF)

First published: 05/02/2010Last updated: 05/02/2010

Work plan for Good Clinical Practice Inspectors Working Group (GCP IWG) for 2009

AdoptedReference Number: EMEA/INS/GCP/449289/2008

English (EN) (83.79 KB - PDF)

First published: 18/03/2009Last updated: 18/03/2009

Work plan for Good Clinical Practice inspectors Working Group (GCP IWG) for 2008

AdoptedReference Number: EMEA/INS/GCP/546619/2007

English (EN) (54.67 KB - PDF)

First published: 12/08/2008Last updated: 12/08/2008

Annual report of the Good Clinical Practice Inspectors Working Group 2023

Reference Number: EMA/INS/GCP/164938/2024

English (EN) (582.95 KB - PDF)

First published: 09/12/2024

Annual report of the Good Clinical Practice Inspectors Working Group 2022

AdoptedReference Number: EMA/INS/GCP/126568/2023

English (EN) (457.71 KB - PDF)

First published: 11/01/2024

Annual Report of the Good Clinical Practice Inspectors' Working Group 2021

AdoptedReference Number: EMA/INS/GCP/33934/2022

English (EN) (409.25 KB - PDF)

First published: 21/11/2022

Annual Report of the Good Clinical Practice Inspectors' Working Group 2020

AdoptedReference Number: EMA/INS/GCP/271107/2022

English (EN) (429.31 KB - PDF)

First published: 20/05/2022

Annual report of the Good Clinical Practice Inspectors Working Group 2019

AdoptedReference Number: EMA/INS/GCP/588463/2020

English (EN) (464.89 KB - PDF)

First published: 10/02/2022

Annual report of the Good Clinical Practice Inspectors' Working Group 2018

AdoptedReference Number: EMA/INS/GCP/819744/2018

English (EN) (445.43 KB - PDF)

First published: 14/05/2020

Annual report of the Good Clinical Practice Inspectors Working Group 2017

AdoptedReference Number: EMA/INS/GCP/779632/2017

English (EN) (455.35 KB - PDF)

First published: 27/11/2018

Annual report of the Good Clinical Practice Inspectors Working Group 2016

AdoptedReference Number: EMA/INS/GCP/763873/2016

English (EN) (299.38 KB - PDF)

First published: 18/08/2017Last updated: 18/08/2017

Annual report of the Good Clinical Practice Inspections Working Group 2015

AdoptedReference Number: EMA/INS/GCP/137204/2016

English (EN) (290.84 KB - PDF)

First published: 01/08/2016Last updated: 01/08/2016

Annual report of the Good Clinical Practice Inspections Working Group 2014

AdoptedReference Number: EMA/INS/GCP/434373/2014

English (EN) (288.15 KB - PDF)

First published: 03/07/2015Last updated: 03/07/2015

Annual report of the Good Clinical Practice Inspectors Working Group 2013

AdoptedReference Number: EMA/INS/GCP/123295/2013

English (EN) (301.85 KB - PDF)

First published: 16/06/2014Last updated: 16/06/2014

Annual report of the Good Clinical Practice Inspectors Working Group 2012

AdoptedReference Number: EMA/627138/2012

English (EN) (238.98 KB - PDF)

First published: 14/06/2013Last updated: 14/06/2013

Annual report of the Good Clinical Practice Inspections Working Group 2011

AdoptedReference Number: EMA/INS/GCP/972336/2011Summary:

This document is the fourth Annual Report of the GCP IWG. This group was established in 1997 under the scope of Article 57(1)(i) of Regulation (EC) No. 726/2004.

English (EN) (220.72 KB - PDF)

First published: 17/07/2012Last updated: 17/07/2012

Annual report of the Good Clinical Practice Inspections Working Group 2010

AdoptedReference Number: EMA/INS/GCP/711391/2010Summary:

This document is the third annual report of the GCP IWG. This group was established in 1997 under the scope of Article 57(1)(i) of Regulation (EC) No. 726/2004.

English (EN) (210.32 KB - PDF)

First published: 17/07/2012Last updated: 17/07/2012

Annual report of the good clinical practice inspections working group 2009

AdoptedReference Number: EMA/INS/GCP/782679/2009

English (EN) (240.96 KB - PDF)

First published: 22/03/2010Last updated: 22/03/2010

Annual report of the good clinical practice inspectors working group 2008

AdoptedReference Number: EMEA/INS/GCP/594196/2008

English (EN) (105.43 KB - PDF)

First published: 18/05/2009Last updated: 18/05/2009

Guideline on computerised systems and electronic data in clinical trials

AdoptedReference Number: EMA/INS/GCP/112288/2023

English (EN) (701.75 KB - PDF)

First published: 10/03/2023

Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol

AdoptedReference Number: EMA/698382/2021

English (EN) (578.86 KB - PDF)

First published: 17/12/2021Last updated: 04/07/2023

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

English (EN) (204.5 KB - DOC)

First published: 17/12/2021Last updated: 04/07/2023

Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic)

AdoptedReference Number: EMA/INS/GCP/856758/2018Legal effective date: 18/06/2019

English (EN) (163.81 KB - PDF)

First published: 18/12/2018

EMA GCP IWG points to consider regarding the management of ongoing clinical trials impacted by political conflicts, natural disasters or other major disruptions

Reference Number: EMA/INS/GCP/622198/2022

English (EN) (165.96 KB - PDF)

First published: 05/04/2023

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 scope of such inspections

AdoptedReference Number: EMA/INS/GCP/167386/2012Legal effective date: 20/08/2013

English (EN) (139.4 KB - PDF)

First published: 20/08/2013Last updated: 20/08/2013

Points to consider on good-clinical-practice inspection findings and the benefit-risk balance

AdoptedReference Number: EMA/868942/2011

English (EN) (136.5 KB - PDF)

First published: 29/01/2013Last updated: 29/01/2013

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

AdoptedReference Number: EMA/151704/2023 (replacing EMA/803916/2022 for the first page disclaimer only)

English (EN) (378.22 KB - PDF)

First published: 04/02/2022Last updated: 05/04/2023

Reflection paper on risk based quality management in clinical trials

AdoptedReference Number: EMA/269011/2013Legal effective date: 22/11/2013Summary:

The aim of these quality management procedures is to provide assurance that the rights, safety and well-being of trial subjects are protected, and that the results of the clinical trials are credible.

English (EN) (251.05 KB - PDF)

First published: 22/11/2013Last updated: 22/11/2013

Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples

AdoptedReference Number: EMA/INS/GCP/532137/2010Legal effective date: 20/03/2012Summary:

The purpose of this reflection paperi is to provide laboratories that perform the analysis or evaluation of human samples collected as part of a clinical trial, with information that will help them develop and maintain quality systems which will comply with relevant European Union Directives, national regulations and associated guidance documents. It will also provide information on the expectations of the inspectors who may be assigned by national monitoring authorities to inspect facilities that perform work in support of human clinical trials.

English (EN) (135.03 KB - PDF)

First published: 20/03/2012Last updated: 20/03/2012

Reflection paper on advice to applicants/sponsors/CROS of bioequivalence studies

AdoptedReference Number: EMEA/INS/GCP/468975/2007

English (EN) (103.63 KB - PDF)

First published: 19/09/2008Last updated: 19/09/2008

Reflection paper on risk-based quality management in clinical trials

Draft: consultation closedConsultation dates: 15/06/2011 to 15/02/2012Reference Number: EMA/INS/GCP/394194/2011Summary:

The aim of this paper is to describe the concept of risk based quality management in the setting of clinical research. Several related approaches have been described that focus on particular aspects of the research. The purpose of this reflection paper is to facilitate the development of a more systematic, prioritised, risk-based approach to quality management of clinical trials, to support the principles of Good Clinical Practice and to complement existing quality practices, requirements and standards.

English (EN) (231.81 KB - PDF)

First published: 05/08/2011Last updated: 05/08/2011

Reflection paper on the use of interactive response technologies (interactive voice/web response systems) in clinical trials

Draft: consultation closedReference Number: EMA/803916/2022

English (EN) (126.72 KB - PDF)

First published: 11/08/2011

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)

AdoptedReference Number: EMA/INS/GCP/600788/2011Legal effective date: 18/12/2013Summary:

Over the last 15 years there has been an increasing utilisation of interactive response technology (IRT), encompassing both interactive voice response systems (IVRS) utilising the telephone or tone diallers and interactive web response systems (IWRS) utilising the internet.

English (EN) (247.44 KB - PDF)

First published: 18/12/2013Last updated: 04/02/2022

Overview of comments received on Reflection paper on the use of interactive response technologies (interactive voice/web response systems) in clinical trials

Reference Number: EMA/INS/GCP/100058/2012

English (EN) (659.08 KB - PDF)

First published: 21/02/2014Last updated: 21/02/2014

Overview of comments received on 'reflection paper on guidance for laboratories that perform the analysis or evaluation of clinical samples'

Reference Number: EMA/INS/GCP/219642/2011

English (EN) (513.73 KB - PDF)

First published: 17/02/2012Last updated: 17/02/2012

Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials (superseded)

AdoptedReference Number: EMA/INS/GCP/454280/2010Legal effective date: 01/08/2010

English (EN) (709.59 KB - PDF)

First published: 12/08/2010Last updated: 12/08/2010

Notice to sponsors on validation and qualification of computerised systems used in clinical trials

Reference Number: EMA/INS/GCP/467532/2019Summary:

The integrity, reliability and robustness of data generated in clinical trials, e.g. data submitted to support marketing authorisation applications (MAAs), are essential to regulators. Most clinical trial data supporting MAAs are now collected through computerised data collection tools, e.g. electronic case report forms (eCRFs) and electronic patient reported outcomes (ePROs).

English (EN) (119.59 KB - PDF)

First published: 15/04/2020

Classification and analysis of the good clinical practice (GCP) inspection findings of GCP inspections conducted at the request of CHMP

Reference Number: INS/GCP/46309/2012

English (EN) (1.23 MB - PDF)

First published: 08/12/2014Last updated: 08/12/2014

Final summary record – EDC systems and risk-based monitoring in Clinical Trials

AdoptedReference Number: EMA/729273/2016

English (EN) (150.39 KB - PDF)

First published: 26/06/2017Last updated: 26/06/2017

Workshop on risk-based quality management in clinical trials 2-3 December 2013: Summaries of the presentations

Reference Number: EMA/84016/2014

English (EN) (97.17 KB - PDF)

First published: 07/07/2014Last updated: 07/07/2014

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

AdoptedReference Number: EMA/INS/GCP/504197/2013

English (EN) (86.56 KB - PDF)

First published: 10/01/2014Last updated: 10/01/2014

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