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
    • Replies: 0
    • Views: 113,069
    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
  1. when to update medical records

    Started by gis8, 1st Jun 2021 03:21 PM
    • Replies: 1
    • Views: 19,949
    6th Jun 2021, 02:33 PM Go to last post
  2. Query regarding Eligibiilty Confirmation

    Started by Heidi_Chandler, 23rd Feb 2022 04:58 PM
    • Replies: 1
    • Views: 25,698
    9th Mar 2022, 07:05 PM Go to last post
  3. CTIMP Retention Period

    Started by null, 15th Mar 2022 12:14 PM
    • Replies: 0
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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
  4. Personal data and archiving

    Started by Research_Gov, 13th Oct 2022 12:00 PM
    • Replies: 0
    • Views: 17,662
    13th Oct 2022, 12:00 PM Go to last post
  5. Oxehealth

    Started by Lee Buckley, 28th Nov 2022 12:39 PM
    • Replies: 0
    • Views: 6,661
    28th Nov 2022, 12:39 PM Go to last post
  6. Site Closure - PI No Longer Available

    Started by s.j.bowden@bham.ac.uk, 21st Dec 2022 11:25 AM
    • Replies: 0
    • Views: 5,597
    21st Dec 2022, 11:25 AM Go to last post
  7. Reporting of exploratory endpoints

    Started by ABR, 19th Jan 2023 05:18 PM
    • Replies: 1
    • Views: 9,738
    29th Jan 2023, 12:25 PM Go to last post
  8. Terminating a Study Site

    Started by Hello123, 19th Jan 2023 05:27 PM
    • Replies: 1
    • Views: 13,368
    20th Mar 2023, 09:37 AM Go to last post
  9. About Informed Consent Form Lost

    Started by yiyuanzhang, 12th Apr 2023 08:29 AM
    • Replies: 3
    • Views: 4,991
    5th May 2023, 03:09 PM Go to last post
  10. Good clinical practice inspection metrics

    Started by ggittens, 30th Nov 2022 11:02 AM
    • Replies: 1
    • Views: 7,450
    9th May 2023, 09:51 AM Go to last post
  11. Patient identifiable data and Archiving ISF

    Started by kathy2023, 14th May 2023 07:34 PM
    • Replies: 1
    • Views: 7,797
    29th May 2023, 07:19 PM Go to last post
  12. Filing of PIS in ISF with original consent

    Started by CarolineC, 18th Aug 2023 03:58 PM
    • Replies: 0
    • Views: 4,166
    18th Aug 2023, 03:58 PM Go to last post
  13. Combined TMF/ISF

    Started by Research_Gov, 17th Oct 2023 01:28 PM
    • Replies: 0
    • Views: 4,851
    17th Oct 2023, 01:28 PM Go to last post

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