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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    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: 112,793
    4th Mar 2016, 01:49 PM Go to last post
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    8th Jan 2016, 10:30 AM Go to last post
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    30th Oct 2013, 04:30 PM Go to last post
  1. Combined TMF/ISF

    Started by Research_Gov, 17th Oct 2023 01:28 PM
    • Replies: 0
    • Views: 4,581
    17th Oct 2023, 01:28 PM Go to last post
  2. 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
  3. Patient identifiable data and Archiving ISF

    Started by kathy2023, 14th May 2023 07:34 PM
    • Replies: 1
    • Views: 7,565
    29th May 2023, 07:19 PM Go to last post
  4. Good clinical practice inspection metrics

    Started by ggittens, 30th Nov 2022 11:02 AM
    • Replies: 1
    • Views: 7,195
    9th May 2023, 09:51 AM Go to last post
  5. About Informed Consent Form Lost

    Started by yiyuanzhang, 12th Apr 2023 08:29 AM
    • Replies: 3
    • Views: 4,938
    5th May 2023, 03:09 PM Go to last post
  6. Terminating a Study Site

    Started by Hello123, 19th Jan 2023 05:27 PM
    • Replies: 1
    • Views: 13,185
    20th Mar 2023, 09:37 AM Go to last post
  7. Reporting of exploratory endpoints

    Started by ABR, 19th Jan 2023 05:18 PM
    • Replies: 1
    • Views: 9,487
    29th Jan 2023, 12:25 PM Go to last post
  8. Site Closure - PI No Longer Available

    Started by s.j.bowden@bham.ac.uk, 21st Dec 2022 11:25 AM
    • Replies: 0
    • Views: 5,554
    21st Dec 2022, 11:25 AM Go to last post
  9. 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
  10. Personal data and archiving

    Started by Research_Gov, 13th Oct 2022 12:00 PM
    • Replies: 0
    • Views: 16,276
    13th Oct 2022, 12:00 PM Go to last post
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    10th Aug 2022, 10:59 AM Go to last post
  11. CTIMP Retention Period

    Started by null, 15th Mar 2022 12:14 PM
    • Replies: 0
    • Views: 15,729
    15th Mar 2022, 12:14 PM Go to last post
  12. Query regarding Eligibiilty Confirmation

    Started by Heidi_Chandler, 23rd Feb 2022 04:58 PM
    • Replies: 1
    • Views: 23,867
    9th Mar 2022, 07:05 PM Go to last post
  13. when to update medical records

    Started by gis8, 1st Jun 2021 03:21 PM
    • Replies: 1
    • Views: 19,687
    6th Jun 2021, 02:33 PM Go to last post
    • Replies: 0
    • Views: 20,640
    4th Jun 2021, 01:39 AM Go to last post
  14. 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
    • Replies: 0
    • Views: 17,666
    7th Dec 2020, 02:57 PM Go to last post
  15. Moved: Protocol training

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

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

    Started by Hopkins75, 22nd Jun 2020 01:01 PM
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  18. Moved: Restriction on number of screening attempts?

    Started by Kar3n, 17th Feb 2020 10:33 AM
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  19. Moved: Enrollement defintion

    Started by CQAO_GEN, 20th Aug 2018 05:35 PM
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  20. Moved: Site staff CVs in TMF?

    Started by KCH, 20th Nov 2017 05:46 PM
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  21. Moved: Exploratory endpoints/ labs: oversight

    Started by PCS76, 17th Jun 2019 11:38 AM
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  22. Moved: Redacting patient identifiers for research archiving

    Started by BasseyK, 12th Jun 2019 08:33 AM
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  23. Moved: Conflict of interest

    Started by debbie.spruce, 13th Feb 2019 11:12 AM
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  24. Moved: PI has left, no new PI available yet.

    Started by M240484, 1st Feb 2019 07:17 AM
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  25. Career Guidance

    Started by ds3427756, 7th Jan 2019 06:35 AM
    • Replies: 1
    • Views: 20,439
    24th Jan 2019, 12:44 PM Go to last post
  26. Moved: Electronic Source Data Access for Monitors and Inspectors

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

    Started by sabrinadey, 2nd Oct 2018 09:28 AM
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