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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    16th Dec 2022, 12:35 PM Go to last post
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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
    • Replies: 0
    • Views: 112,805
    4th Mar 2016, 01:49 PM Go to last post
    • Replies: 0
    • Views: 106,455
    8th Jul 2016, 12:51 PM Go to last post
  1. Reporting of exploratory endpoints

    Started by ABR, 19th Jan 2023 05:18 PM
    • Replies: 1
    • Views: 9,491
    29th Jan 2023, 12:25 PM Go to last post
  2. Moved: Redacting patient identifiers for research archiving

    Started by BasseyK, 12th Jun 2019 08:33 AM
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  3. Moved: Deleted records by site in error

    Started by blsm002, 22nd Sep 2014 06:49 AM
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  4. Filing of PIS in ISF with original consent

    Started by CarolineC, 18th Aug 2023 03:58 PM
    • Replies: 0
    • Views: 4,003
    18th Aug 2023, 03:58 PM Go to last post
  5. Moved: Medical Images Requirements

    Started by castede1, 22nd Dec 2014 09:17 PM
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  6. Moved: Enrollement defintion

    Started by CQAO_GEN, 20th Aug 2018 05:35 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. Career Guidance

    Started by ds3427756, 7th Jan 2019 06:35 AM
    • Replies: 1
    • Views: 20,442
    24th Jan 2019, 12:44 PM Go to last post
  9. Good clinical practice inspection metrics

    Started by ggittens, 30th Nov 2022 11:02 AM
    • Replies: 1
    • Views: 7,199
    9th May 2023, 09:51 AM Go to last post
  10. when to update medical records

    Started by gis8, 1st Jun 2021 03:21 PM
    • Replies: 1
    • Views: 19,698
    6th Jun 2021, 02:33 PM Go to last post
  11. Query regarding Eligibiilty Confirmation

    Started by Heidi_Chandler, 23rd Feb 2022 04:58 PM
    • Replies: 1
    • Views: 23,918
    9th Mar 2022, 07:05 PM Go to last post
  12. Terminating a Study Site

    Started by Hello123, 19th Jan 2023 05:27 PM
    • Replies: 1
    • Views: 13,188
    20th Mar 2023, 09:37 AM Go to last post
  13. Moved: SOP Sign off

    Started by Hopkins75, 22nd Jun 2020 01:01 PM
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  14. Moved: Consent in Emergency Research

    Started by Hugh Davies, 2nd Oct 2012 02:41 PM
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  15. Moved: Regulations governing Screening studies

    Started by jambun, 27th Feb 2018 12:45 PM
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  16. Chief investigators and site data

    Started by jmp36t, 21st May 2021 12:03 PM
    • Replies: 1
    • Views: 15,765
    26th May 2021, 05:08 PM Go to last post
  17. Moved: Restriction on number of screening attempts?

    Started by Kar3n, 17th Feb 2020 10:33 AM
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  18. Patient identifiable data and Archiving ISF

    Started by kathy2023, 14th May 2023 07:34 PM
    • Replies: 1
    • Views: 7,566
    29th May 2023, 07:19 PM Go to last post
  19. Moved: Site staff CVs in TMF?

    Started by KCH, 20th Nov 2017 05:46 PM
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  20. Moved: clinical trials in homecare pharmacies

    Started by Kiran Bharaj, 23rd Jan 2015 12:59 PM
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  21. Oxehealth

    Started by Lee Buckley, 28th Nov 2022 12:39 PM
    • Replies: 0
    • Views: 6,615
    28th Nov 2022, 12:39 PM Go to last post
  22. Moved: PI has left, no new PI available yet.

    Started by M240484, 1st Feb 2019 07:17 AM
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    7th Dec 2020, 02:57 PM Go to last post
  23. Moved: Clinical trials labels requirements

    Started by martak, 19th Jul 2018 10:13 AM
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  24. MHRA GCP Symposium 2018

    Started by MHRA Super Moderator, 12th Jun 2018 10:41 AM
    • Replies: 0
    • Views: 63,371
    12th Jun 2018, 10:41 AM Go to last post
  25. Moved: Electronic Source Data Access for Monitors and Inspectors

    Started by Mikayala, 16th Nov 2018 09:51 AM
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  26. Moved: SUSARs sent to pharmacies

    Started by Nikki Dewick, 23rd Oct 2015 12:43 PM
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  27. CTIMP Retention Period

    Started by null, 15th Mar 2022 12:14 PM
    • Replies: 0
    • Views: 15,733
    15th Mar 2022, 12:14 PM Go to last post
  28. Moved: Exploratory endpoints/ labs: oversight

    Started by PCS76, 17th Jun 2019 11:38 AM
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