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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    8th Jul 2016, 12:51 PM Go to last post
  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: 27,870
    4th Mar 2016, 01:49 PM Go to last post
    • Replies: 0
    • Views: 35,269
    8th Jan 2016, 10:30 AM Go to last post
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    • Views: 35,136
    30th Oct 2013, 04:30 PM Go to last post
  1. Site staff CVs in TMF?

    Started by KCH, 20th Nov 2017 05:46 PM
    • Replies: 1
    • Views: 9,252
    1st Oct 2019, 08:21 PM Go to last post
  2. Exploratory endpoints/ labs: oversight

    Started by PCS76, 17th Jun 2019 11:38 AM
    • Replies: 0
    • Views: 1,329
    17th Jun 2019, 11:38 AM Go to last post
  3. Redacting patient identifiers for research archiving

    Started by BasseyK, 12th Jun 2019 08:33 AM
    • Replies: 1
    • Views: 1,464
    14th Jun 2019, 07:42 PM Go to last post
  4. Conflict of interest

    Started by debbie.spruce, 13th Feb 2019 11:12 AM
    • Replies: 2
    • Views: 2,196
    18th Feb 2019, 12:14 PM Go to last post
  5. PI has left, no new PI available yet.

    Started by M240484, 1st Feb 2019 07:17 AM
    • Replies: 1
    • Views: 2,224
    5th Feb 2019, 07:37 PM Go to last post
  6. Career Guidance

    Started by ds3427756, 7th Jan 2019 06:35 AM
    • Replies: 1
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    24th Jan 2019, 12:44 PM Go to last post
  7. Enrollement defintion

    Started by CQAO_GEN, 20th Aug 2018 05:35 PM
    • Replies: 1
    • Views: 6,691
    25th Nov 2018, 01:32 AM Go to last post
  8. Moved: Electronic Source Data Access for Monitors and Inspectors

    Started by Mikayala, 16th Nov 2018 09:51 AM
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  9. Sunshine Act

    Started by sabrinadey, 2nd Oct 2018 09:28 AM
    • Replies: 0
    • Views: 6,416
    2nd Oct 2018, 09:28 AM Go to last post
  10. Interventional clinical trial

    Started by Raju, 14th Aug 2018 04:20 PM
    • Replies: 0
    • Views: 6,355
    14th Aug 2018, 04:20 PM Go to last post
  11. Clinical trials labels requirements

    Started by martak, 19th Jul 2018 10:13 AM
    • Replies: 0
    • Views: 6,170
    19th Jul 2018, 10:13 AM Go to last post
  12. MHRA GCP Symposium 2018

    Started by MHRA Super Moderator, 12th Jun 2018 10:41 AM
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    12th Jun 2018, 10:41 AM Go to last post
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    26th May 2018, 04:20 PM Go to last post
  13. Regulations governing Screening studies

    Started by jambun, 27th Feb 2018 12:45 PM
    • Replies: 0
    • Views: 8,033
    27th Feb 2018, 12:45 PM Go to last post
  14. Source Data - NHS Digital

    Started by qaman, 26th Jan 2018 02:25 PM
    • Replies: 0
    • Views: 8,532
    26th Jan 2018, 02:25 PM Go to last post
  15. Patient and Public Involvement (PPI)

    Started by Peter Bates, 8th Dec 2017 08:48 PM
    • Replies: 0
    • Views: 8,375
    8th Dec 2017, 08:48 PM Go to last post
  16. ICH GCP R2 - ongoing trials that started on R1

    Started by sabrinadey, 26th Apr 2017 01:05 PM
    • Replies: 0
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    26th Apr 2017, 01:05 PM Go to last post
  17. Moved: SUSARs sent to pharmacies

    Started by Nikki Dewick, 23rd Oct 2015 12:43 PM
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  18. Moved: clinical trials in homecare pharmacies

    Started by Kiran Bharaj, 23rd Jan 2015 12:59 PM
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  19. Moved: Medical Images Requirements

    Started by castede1, 22nd Dec 2014 09:17 PM
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  20. Moved: Deleted records by site in error

    Started by blsm002, 22nd Sep 2014 06:49 AM
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  21. Moved: Consent in Emergency Research

    Started by Hugh Davies, 2nd Oct 2012 02:41 PM
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