Good Clinical Practice Guide
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Forum: Good Clinical Practice (GCP)

The GCP forum has been created as a tool to help those involved in clinical trials of Investigational Medicinal Products to comply with the clinical trials legislation and GCP requirements. It provides the ideal opportunity for extended communication between researchers and allows users to put forward their comments and get ?real-life? examples of ways in which they can manage robust quality procedures that ensure compliance and which dovetail with their own business needs and resources.

This forum should not be used for direct questions to the GCP Inspectorate/Clinical Trials Unit, reporting serious breaches or making formal complaints. These should follow the formal routes that are already in place.

Please read the Good Clinical Practice (GCP) Forum introduction and rules before posting on this forum.

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  1. GCP Forum introduction and rules - PLEASE READ BEFORE POSTING ON THIS FORUM

    Please read the Good Clinical Practice (GCP) forum introduction and rules before posting on this forum.

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  2. Clinical laboratories

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  3. Computer system validation (CSV) and IT systems

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  4. Contracts and agreements (including insurance)

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  5. Data management

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  6. Electronic Systems (inc. e-CRF, e-source, ePRo and ehealth records/EHR)

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  7. Equipment maintenance

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  8. Ethics approval

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  9. Inspection process

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  10. Investigational Medicinal Products (IMP)

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  11. Investigator Sites (inc Principal Investigator responsibilities, consent, source data and CRFs)

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  12. Legislation

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  13. Monitoring

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  14. Pharmacovigilance

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  15. Programme management

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    Never

  16. Quality Systems (including QA, SOP and Training)

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  17. Risk adaptive approach

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  18. Risk-based inspections

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  19. Regulatory documents (including protocol, clinical study reports and publications)

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  20. Sponsor oversight

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  21. Statistics

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  22. Trial Master File (TMF) and archiving

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  1. Sticky Thread Sticky: Questions on Clinical Trials if we leave the EU

    Started by MHRA Super Moderator, 4th Mar 2016 01:49 PM
    • Replies: 0
    • Views: 116,228
    MHRA Super Moderator
    4th Mar 2016, 01:49 PM Go to last post

  2. Sticky Thread Sticky: Public Consultation on communication of medicines and medical devices safety info

    Started by MHRA Moderator, 16th Dec 2022 12:35 PM
    #publicconsultation
    • Replies: 0
    • Views: 10,009
    MHRA Moderator
    16th Dec 2022, 12:35 PM Go to last post

  3. Sticky Thread Sticky: MHRA make changes to clinical trials phase I accreditation scheme

    Started by MHRA Super Moderator, 30th Oct 2013 04:30 PM
    • Replies: 0
    • Views: 118,441
    MHRA Super Moderator
    30th Oct 2013, 04:30 PM Go to last post

  4. Sticky Thread Sticky: EU Clinical Trials New Regulation – Important Consultations HAVE YOUR SAY

    Started by MHRA Super Moderator, 8th Jul 2016 12:51 PM
    • Replies: 0
    • Views: 109,959
    MHRA Super Moderator
    8th Jul 2016, 12:51 PM Go to last post

  5. Sticky Thread Sticky: CTA submission now only accepted via Common European Submission Platform (CESP)

    Started by MHRA Super Moderator, 8th Jan 2016 10:30 AM
    • Replies: 0
    • Views: 114,213
    MHRA Super Moderator
    8th Jan 2016, 10:30 AM Go to last post

  1. Moved: Exclusion criterion - participation in previous clinical trial within three months

    Started by SRH, 25th Feb 2015 04:19 PM
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  2. Moved: Enrollement defintion

    Started by CQAO_GEN, 20th Aug 2018 05:35 PM
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  3. Moved: Electronic Source Data Access for Monitors and Inspectors

    Started by Mikayala, 16th Nov 2018 09:51 AM
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  4. Moved: Deleted records by site in error

    Started by blsm002, 22nd Sep 2014 06:49 AM
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  5. CTIMP Retention Period

    Started by null, 15th Mar 2022 12:14 PM
    • Replies: 0
    • Views: 16,903
    null
    15th Mar 2022, 12:14 PM Go to last post

  6. Moved: Consent in Emergency Research

    Started by Hugh Davies, 2nd Oct 2012 02:41 PM
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  7. Moved: Conflict of interest

    Started by debbie.spruce, 13th Feb 2019 11:12 AM
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  8. Combined TMF/ISF

    Started by Research_Gov, 17th Oct 2023 01:28 PM
    • Replies: 0
    • Views: 5,883
    Research_Gov
    17th Oct 2023, 01:28 PM Go to last post

  9. Moved: Clinical trials labels requirements

    Started by martak, 19th Jul 2018 10:13 AM
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  10. Moved: clinical trials in homecare pharmacies

    Started by Kiran Bharaj, 23rd Jan 2015 12:59 PM
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  11. clinical trial design phase I/II from three arms to two arms trial

    Started by Ran, 4th Jun 2021 01:39 AM
    • Replies: 0
    • Views: 22,108
    Ran
    4th Jun 2021, 01:39 AM Go to last post

  12. Chief investigators and site data

    Started by jmp36t, 21st May 2021 12:03 PM
    • Replies: 1
    • Views: 17,086
    a123456
    26th May 2021, 05:08 PM Go to last post

  13. Career Guidance

    Started by ds3427756, 7th Jan 2019 06:35 AM
    • Replies: 1
    • Views: 23,043
    a123456
    24th Jan 2019, 12:44 PM Go to last post

  14. Moved: Adverse event before dosing

    Started by quality234, 29th Jun 2020 08:28 AM
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  15. About Informed Consent Form Lost

    Started by yiyuanzhang, 12th Apr 2023 08:29 AM
    • Replies: 3
    • Views: 5,408
    a123456
    5th May 2023, 03:09 PM Go to last post
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