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

Use EMA's online form to send any queries about this content.

Documents of interest

Annual Report of the Good Clinical Practice Inspectors Working Group 2022

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

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

Reference Number: EMA/INS/GCP/329215/2023

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

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

Guideline on computerised systems and electronic data in clinical trials

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

Draft guideline on computerised systems and electronic data in clinical trials

Consultation dates: 18/06/2021 to 17/12/2021Draft: consultation closedReference Number: EMA/226170/2021Summary:

This guideline replaces ‘Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials’ (EMA/INS/GCP/454280/2010).

Keywords: Computerised systems, electronic data, validation, qualification, audit trail, user management, security, electronic clinical outcome assessment (eCOA), Interactive response technology (IRT), case report form (CRF), electronic signatures, artificial intelligence

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

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

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

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

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

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

Annual Report of the Good Clinical Practice Inspectors Working Group 2019

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

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)

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

AdoptedReference Number: EMA/698382/2021

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

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).

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

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

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

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

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

AdoptedLegal effective date: 18/06/2019Reference Number: EMA/INS/GCP/856758/2018

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

Consultation dates: 23/05/2018 to 31/08/2018Draft: consultation closedReference Number: EMA/202679/2018Summary:

The guideline lays down the principles for the two-step release and shipping of the investigational medicinal products by the qualified person and the sponsor. The guideline also describes the areas of interface between the manufacturer and the sponsor and the required contractual agreements.

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

AdoptedReference Number: EMA/729273/2016

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

Consultation dates: 23/05/2017 to 22/08/2017Draft: consultation closedReference Number: EMA/430909/2016Summary:

This guideline outlines the practical arrangements for notification of serious breaches of clinical trials authorised in the Europe Union / European Economic Area. It aims to provide advice on what should and what should not be classified as a serious breach and what must be reported. It does not include guidance related to urgent safety measures or other reporting obligations related to subject safety.

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

Consultation dates: 12/04/2017 to 11/07/2017Draft: consultation closedReference Number: EMA/15975/2016Summary:

The guideline on Trial Master File (TMF) aims to describe the requirements for TMF as covered in the new Clinical Trials Regulation (EU) No 536/2014 and ICH-GCP E6 and to assist organisations in maintaining a TMF that facilitates trial management, good-clinical-practice (GCP) compliance and inspection. The document also addresses archiving of the TMF, clarifying retention times, in particular expectations in case of digitisation and consecutive destruction of paper documentation.

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

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

Reference Number: EMA/84016/2014

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

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

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)

AdoptedLegal effective date: 18/12/2013Reference Number: EMA/INS/GCP/600788/2011Summary:

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.

Reflection paper on risk based quality management in clinical trials

AdoptedLegal effective date: 22/11/2013Reference Number: EMA/269011/2013Summary:

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.

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...

AdoptedLegal effective date: 20/08/2013Reference Number: EMA/INS/GCP/167386/2012

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

Consultation dates: 01/02/2013 to 30/04/2013Draft: consultation closedReference Number: EMA/INS/GCP/636736/2012Summary:

This reflection paper has been prepared to bring together the requirements of European Union (EU) legislation and guidance relating to the trial master file (TMF). This is deemed necessary by the EU Good Clinical Practice Inspectors Working Group inspectors due to the numerous questions asked by organisations in relation to the TMF (in particular electronic TMFs) and also to the repeated inspection findings concerning the TMF that have been made.

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

AdoptedReference Number: EMA/868942/2011

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

AdoptedLegal effective date: 20/03/2012Reference Number: EMA/INS/GCP/532137/2010Summary:

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.

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

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

Draft: consultation closedReference Number: EMA/803916/2022

Reflection paper on risk-based quality management in clinical trials

Consultation dates: 15/06/2011 to 15/02/2012Draft: consultation closedReference 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.

Draft reflection paper on guidance for laboratories that perform the analysis or evaluation of clinical trial samples

Consultation dates: 10/06/2010 to 28/02/2011Draft: consultation closedReference Number: EMA/INS/GCP/532137/2010

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

AdoptedLegal effective date: 01/08/2010Reference Number: EMA/INS/GCP/454280/2010

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

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

Draft reflection paper on expectations for electronic source documents used in clinical trials

Draft: consultation closedReference Number: EMEA/505620/2007

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

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

Document archive

Work plan for Good Clinical Practice Inspectors Working Group 2018

AdoptedReference Number: EMA/87812 /2018

Annual report of the Good Clinical Practice Inspectors' Working Group 2017

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

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

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

Annual report of the Good Clinical Practice Inspectors Working Group 2016

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

Work plan for Good Clinical Practice Inspectors Working Group 2016

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

Annual report of the Good Clinical Practice Inspections Working Group 2015

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

Work plan for Good Clinical Practice Inspectors Working Group 2015

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

Annual report of the Good Clinical Practice Inspections Working Group 2014

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

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.

Annual report of the Good Clinical Practice Inspectors Working Group 2013

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

Work plan for Good Clinical Practice Inspectors Working Group 2013

AdoptedReference Number: EMA/569405/2012

Annual report of the Good Clinical Practice Inspectors Working Group 2012

AdoptedReference Number: EMA/627138/2012

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

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

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.

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

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

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.

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

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

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

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

Annual report of the good clinical practice inspections working group 2009

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

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

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

Annual report of the good clinical practice inspectors working group 2008

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