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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    30th Oct 2013, 04:30 PM Go to last post
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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
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    4th Mar 2016, 01:49 PM Go to last post
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    8th Jul 2016, 12:51 PM Go to last post
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    16th Dec 2022, 12:35 PM Go to last post
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  1. Moved: Medical Images Requirements

    Started by castede1, 22nd Dec 2014 09:17 PM
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  2. Moved: clinical trials in homecare pharmacies

    Started by Kiran Bharaj, 23rd Jan 2015 12:59 PM
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  3. Moved: SUSARs sent to pharmacies

    Started by Nikki Dewick, 23rd Oct 2015 12:43 PM
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  4. MHRA GCP Symposium 2018

    Started by MHRA Super Moderator, 12th Jun 2018 10:41 AM
    • Replies: 0
    • Views: 63,358
    12th Jun 2018, 10:41 AM Go to last post
  5. Patient and Public Involvement (PPI)

    Started by Peter Bates, 8th Dec 2017 08:48 PM
    • Replies: 0
    • Views: 86,777
    8th Dec 2017, 08:48 PM Go to last post
  6. Source Data - NHS Digital

    Started by qaman, 26th Jan 2018 02:25 PM
    • Replies: 0
    • Views: 76,443
    26th Jan 2018, 02:25 PM Go to last post
  7. Moved: ICH GCP R2 - ongoing trials that started on R1

    Started by sabrinadey, 26th Apr 2017 01:05 PM
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  8. Moved: Exploratory endpoints/ labs: oversight

    Started by PCS76, 17th Jun 2019 11:38 AM
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  9. Moved: Clinical trials labels requirements

    Started by martak, 19th Jul 2018 10:13 AM
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  10. Moved: Regulations governing Screening studies

    Started by jambun, 27th Feb 2018 12:45 PM
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  11. Moved: Protocol training

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

    Started by quality234, 29th Jun 2020 08:28 AM
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  13. Moved: SOP Sign off

    Started by Hopkins75, 22nd Jun 2020 01:01 PM
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  14. Moved: Sunshine Act

    Started by sabrinadey, 2nd Oct 2018 09:28 AM
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  15. Moved: Interventional clinical trial

    Started by Raju, 14th Aug 2018 04:20 PM
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    7th Dec 2020, 02:57 PM Go to last post
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    4th Jun 2021, 01:39 AM Go to last post
  16. CTIMP Retention Period

    Started by null, 15th Mar 2022 12:14 PM
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    15th Mar 2022, 12:14 PM Go to last post
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    10th Aug 2022, 10:59 AM Go to last post
  17. Personal data and archiving

    Started by Research_Gov, 13th Oct 2022 12:00 PM
    • Replies: 0
    • Views: 16,271
    13th Oct 2022, 12:00 PM Go to last post
  18. Oxehealth

    Started by Lee Buckley, 28th Nov 2022 12:39 PM
    • Replies: 0
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    28th Nov 2022, 12:39 PM Go to last post
  19. Site Closure - PI No Longer Available

    Started by s.j.bowden@bham.ac.uk, 21st Dec 2022 11:25 AM
    • Replies: 0
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    21st Dec 2022, 11:25 AM Go to last post
  20. Filing of PIS in ISF with original consent

    Started by CarolineC, 18th Aug 2023 03:58 PM
    • Replies: 0
    • Views: 3,997
    18th Aug 2023, 03:58 PM Go to last post
  21. Combined TMF/ISF

    Started by Research_Gov, 17th Oct 2023 01:28 PM
    • Replies: 0
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    17th Oct 2023, 01:28 PM Go to last post
  22. Moved: Site staff CVs in TMF?

    Started by KCH, 20th Nov 2017 05:46 PM
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  23. Moved: PI has left, no new PI available yet.

    Started by M240484, 1st Feb 2019 07:17 AM
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  24. Moved: Redacting patient identifiers for research archiving

    Started by BasseyK, 12th Jun 2019 08:33 AM
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  25. Chief investigators and site data

    Started by jmp36t, 21st May 2021 12:03 PM
    • Replies: 1
    • Views: 15,761
    26th May 2021, 05:08 PM Go to last post

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