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: 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: 9,631
    MHRA Moderator
    16th Dec 2022, 12:35 PM Go to last post

  2. 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: 116,210
    MHRA Super Moderator
    30th Oct 2013, 04:30 PM Go to last post

  3. 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: 111,835
    MHRA Super Moderator
    8th Jan 2016, 10:30 AM Go to last post

  4. 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: 113,872
    MHRA Super Moderator
    4th Mar 2016, 01:49 PM Go to last post

  5. 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: 107,427
    MHRA Super Moderator
    8th Jul 2016, 12:51 PM Go to last post

  1. Moved: Exploratory endpoints/ labs: oversight

    Started by PCS76, 17th Jun 2019 11:38 AM
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  2. Patient and Public Involvement (PPI)

    Started by Peter Bates, 8th Dec 2017 08:48 PM
    • Replies: 0
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    Peter Bates
    8th Dec 2017, 08:48 PM Go to last post

  3. Source Data - NHS Digital

    Started by qaman, 26th Jan 2018 02:25 PM
    • Replies: 0
    • Views: 77,284
    qaman
    26th Jan 2018, 02:25 PM Go to last post

  4. Moved: Protocol training

    Started by quality234, 29th Jun 2020 08:29 AM
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  5. Moved: Adverse event before dosing

    Started by quality234, 29th Jun 2020 08:28 AM
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  6. Moved: Interventional clinical trial

    Started by Raju, 14th Aug 2018 04:20 PM
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  7. 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: 21,301
    Ran
    4th Jun 2021, 01:39 AM Go to last post

  8. Personal data and archiving

    Started by Research_Gov, 13th Oct 2022 12:00 PM
    • Replies: 0
    • Views: 22,116
    Research_Gov
    13th Oct 2022, 12:00 PM Go to last post

  9. Combined TMF/ISF

    Started by Research_Gov, 17th Oct 2023 01:28 PM
    • Replies: 0
    • Views: 5,424
    Research_Gov
    17th Oct 2023, 01:28 PM Go to last post

  10. Site Closure - PI No Longer Available

    Started by s.j.bowden@bham.ac.uk, 21st Dec 2022 11:25 AM
    • Replies: 0
    • Views: 5,693
    s.j.bowden@bham.ac.uk
    21st Dec 2022, 11:25 AM Go to last post

  11. Moved: ICH GCP R2 - ongoing trials that started on R1

    Started by sabrinadey, 26th Apr 2017 01:05 PM
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  12. Moved: Sunshine Act

    Started by sabrinadey, 2nd Oct 2018 09:28 AM
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  13. Moved: Exclusion criterion - participation in previous clinical trial within three months

    Started by SRH, 25th Feb 2015 04:19 PM
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  14. About Informed Consent Form Lost

    Started by yiyuanzhang, 12th Apr 2023 08:29 AM
    • Replies: 3
    • Views: 5,093
    a123456
    5th May 2023, 03:09 PM Go to last post

  15. Sponsorship activities within subsidiary organisations

    Started by ztarfizh, 10th Aug 2022 10:59 AM
    • Replies: 0
    • Views: 12,318
    ztarfizh
    10th Aug 2022, 10:59 AM Go to last post
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