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    Guidance For The Communication On GCP Inspections and Findings en PDF

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    MarcM77
    This document provides guidance for communicating GCP inspection reports and findings between competent authorities of EU Member States. It outlines that inspection reports will be entered into the EUDRACT database and distributed within the inspecting Member State according to national procedures. Essential findings will also be communicated to other Member States through the GCP Inspectors Working Group to ensure relevant information is shared across the EU. The scope is to provide a unified standard for conducting and reporting on GCP inspections of clinical trial sites.

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    Guidance For The Communication On GCP Inspections and Findings en PDF

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    MarcM77
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    This document provides guidance for communicating GCP inspection reports and findings between competent authorities of EU Member States. It outlines that inspection reports will be entered into the EUDRACT database and distributed within the inspecting Member State according to national procedures. Essential findings will also be communicated to other Member States through the GCP Inspectors Working Group to ensure relevant information is shared across the EU. The scope is to provide a unified standard for conducting and reporting on GCP inspections of clinical trial sites.

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    This document provides guidance for communicating GCP inspection reports and findings between competent authorities of EU Member States. It outlines that inspection reports will be entered into the EUDRACT database and distributed within the inspecting Member State according to national procedures. Essential findings will also be communicated to other Member States through the GCP Inspectors Working Group to ensure relevant information is shared across the EU. The scope is to provide a unified standard for conducting and reporting on GCP inspections of clinical trial sites.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    29 views4 pages

    Guidance For The Communication On GCP Inspections and Findings en PDF

    Uploaded by

    MarcM77
    This document provides guidance for communicating GCP inspection reports and findings between competent authorities of EU Member States. It outlines that inspection reports will be entered into the EUDRACT database and distributed within the inspecting Member State according to national procedures. Essential findings will also be communicated to other Member States through the GCP Inspectors Working Group to ensure relevant information is shared across the EU. The scope is to provide a unified standard for conducting and reporting on GCP inspections of clinical trial sites.

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    © All Rights Reserved
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    of 4

    EUROPEAN COMMISSION

    ENTERPRISE and INDUSTRY DIRECTORATE-GENERAL

    Consumer goods
    Pharmaceuticals

    GUIDANCE DOCUMENTS
    CONTAINING THE COMMON PROVISIONS
    ON THE CONDUCT OF GCP INSPECTIONS BY COMPETENT
    AUTHORITIES OF THE DIFFERENT MEMBER STATES

    GUIDANCE FOR THE COMMUNICATION ON GOOD


    CLINICAL PRACTICE INSPECTIONS AND FINDINGS

    Version: 28 May 2008

    This document forms part of the guidance documents containing the common provisions on the conduct
    of GCP inspections . Please check for updates in the Volume 10 of the Rules Governing Medicinal
    Products in the European Union.
    http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol10_en.htm
    1 INTRODUCTION.....................................................................................................................3

    2 REPORTING ............................................................................................................................3

    3 REPORTING IN EUDRACT...................................................................................................3

    4 COMMUNICATION WITHIN A MEMBER STATE ............................................................3

    5 REFERENCES .........................................................................................................................4

    Page 2/4
    1 INTRODUCTION

    The scope of this document is to provide guidance for communication of GCP inspection reports and
    findings following a GCP inspection carried out by competent authorities of the different Member
    States, which may take place on any of the following occasions:

    (a) before, during or after the conduct of clinical trials;


    (b) as part of the verification of applications for marketing authorisation;
    (c) as a follow-up to the granting of authorisation.

    The scope of this guidance is to provide unified standards on the conduct of GCP inspections that are
    applicable for any site to be inspected. This guidance takes into account the following procedure:
    • “Guidance for Preparation of Good Clinical Practice inspection reports”, which describes the
    contents of GCP inspection reports and the procedure for their approval.

    2 REPORTING
    Following the conduct of the GCP inspection a report will be written in accordance with the “Guidance
    for Preparation of Good Clinical Practice inspection reports”.

    The circulation of inspection reports (deadline to reply) will be set according to the “Guidance for
    Preparation of Good Clinical Practice inspection reports”, and national procedures, if applicable.

    An inspection report will be defined as complete when the inspector(s) has/have assessed the responses
    from the inspectee(s) on the findings described in the original inspection report.

    3 REPORTING IN EUDRACT
    It is the responsibility of the Lead Inspector to ensure that the GCP inspection is documented in the
    EUDRACT database for inspections in accordance with the Commission Directive 2005/28/EC. This
    database entry should be performed as soon as possible following the actual conduct of the GCP
    inspection.

    4 COMMUNICATION WITHIN A MEMBER STATE


    The GCP inspection report will be distributed and circulated within a Member State in accordance
    with the local regulations (see also Guidance for Preparation of Good Clinical Practice Inspection
    Reports, Section 2.3, Forwarding the IR). Furthermore, it is the responsibility of the Lead Inspector to
    ensure that relevant staff in the Member State receives adequate information about the GCP inspection
    and its findings, where this information may be of value for the receiving staff in future decision or
    evaluations.

    5 COMMUNICATION WITHIN A MEMBER STATE SHOULD TEXT FROM GUIDANCE

    Essential information about the inspection and its findings is entered in the EUDRACT database;
    therefore, the GCP inspection report will normally not be circulated to other Member States
    Competent authorities. Under specific circumstances it might, however, be necessary to share the
    information obtained during an inspection and such request will be in accordance with the "Guidance
    for exchange of GCP Inspection Reports according to Directive 2001/20/EC Article 15 (2)”. In order to
    ensure that relevant findings are communicated within the European Community it is the
    responsibility of the Lead Inspector to inform other Member States about these findings. This can be

    Page 3/4
    performed as a communication during the GCP Inspectors Working Group meetings at the EMEA
    under agenda items "GCP Inspection and compliance issues of community interest". If a finding has
    direct bearing on the quality of the study or patient safety and/integrity in other participating Member
    States in the study, it is the responsibility of the Lead Inspector to contact the relevant GCP Inspector
    in those countries.

    5 REFERENCES
    • Directive 2001/20/EC on the approximation of the laws, regulations and administrative provisions
    of the Member States relating to the implementation of good clinical practice in the conduct of
    clinical trials on medicinal products for human use.
    • Directive 2005/28/EC laying down principles and detailed guidelines for good clinical practice as
    regards investigational medicinal products for human use, as well as the requirements for
    authorisation of the manufacturing or importation of such product.
    • Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the
    community code relating to medicinal products for human use, as amended.
    • Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004
    laying down Community procedures for the authorisation and supervision of medicinal products
    for human and veterinary use and establishing a European Medicines Agency.
    • EUDRALEX Volume 10 - Clinical trials, of the Rules Governing Medicinal Products in the
    European Union: http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol10_en.htm

    Page 4/4

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