Good Clinical Practice Guide
Page 1 of 2 12 LastLast
Threads 1 to 30 of 45

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.

Topics Threads / Posts  Last post

  1. GCP Forum introduction and rules - PLEASE READ BEFORE POSTING ON THIS FORUM

    Please read the Good Clinical Practice (GCP) forum introduction and rules before posting on this forum.

    Forum actions:

    forum statistics:

    • Threads: 1
    • Posts: 1

    Last post:

  2. Clinical laboratories

    Forum actions:

    forum statistics:

    • Threads: 15
    • Posts: 31

    Last post:

  3. Computer system validation (CSV) and IT systems

    Forum actions:

    forum statistics:

    • Threads: 17
    • Posts: 60

    Last post:

  4. Contracts and agreements (including insurance)

    Forum actions:

    forum statistics:

    • Threads: 3
    • Posts: 6

    Last post:

  5. Data management

    Forum actions:

    forum statistics:

    • Threads: 17
    • Posts: 40

    Last post:

  6. Electronic Systems (inc. e-CRF, e-source, ePRo and ehealth records/EHR)

    Forum actions:

    forum statistics:

    • Threads: 16
    • Posts: 29

    Last post:

  7. Equipment maintenance

    Forum actions:

    forum statistics:

    • Threads: 7
    • Posts: 13

    Last post:

  8. Ethics approval

    Forum actions:

    forum statistics:

    • Threads: 5
    • Posts: 9

    Last post:

  9. Inspection process

    Forum actions:

    forum statistics:

    • Threads: 4
    • Posts: 10

    Last post:

  10. Investigational Medicinal Products (IMP)

    Forum actions:

    forum statistics:

    • Threads: 54
    • Posts: 127

    Last post:

  11. Investigator Sites (inc Principal Investigator responsibilities, consent, source data and CRFs)

    Forum actions:

    forum statistics:

    • Threads: 81
    • Posts: 230

    Last post:

  12. Legislation

    Forum actions:

    forum statistics:

    • Threads: 15
    • Posts: 46

    Last post:

  13. Monitoring

    Forum actions:

    forum statistics:

    • Threads: 14
    • Posts: 63

    Last post:

  14. Pharmacovigilance

    Forum actions:

    forum statistics:

    • Threads: 28
    • Posts: 63

    Last post:

  15. Programme management

    Forum actions:

    forum statistics:

    • Threads: 0
    • Posts: 0

    Last post:

    Never

  16. Quality Systems (including QA, SOP and Training)

    Forum actions:

    forum statistics:

    • Threads: 21
    • Posts: 45

    Last post:

  17. Risk adaptive approach

    Forum actions:

    forum statistics:

    • Threads: 6
    • Posts: 32

    Last post:

  18. Risk-based inspections

    Forum actions:

    forum statistics:

    • Threads: 2
    • Posts: 2

    Last post:

  19. Regulatory documents (including protocol, clinical study reports and publications)

    Forum actions:

    forum statistics:

    • Threads: 6
    • Posts: 12

    Last post:

  20. Sponsor oversight

    Forum actions:

    forum statistics:

    • Threads: 9
    • Posts: 18

    Last post:

  21. Statistics

    Forum actions:

    forum statistics:

    • Threads: 2
    • Posts: 3

    Last post:

  22. Trial Master File (TMF) and archiving

    Forum actions:

    forum statistics:

    • Threads: 43
    • Posts: 111

    Last post:

  1. Sticky Thread Sticky: Public Consultation on communication of medicines and medical devices safety info

    Started by MHRA Moderator, 16th Dec 2022 12:35 PM
    #publicconsultation
    • Replies: 0
    • Views: 9,603
    MHRA Moderator
    16th Dec 2022, 12:35 PM Go to last post

  2. Sticky Thread Sticky: EU Clinical Trials New Regulation – Important Consultations HAVE YOUR SAY

    Started by MHRA Super Moderator, 8th Jul 2016 12:51 PM
    • Replies: 0
    • Views: 106,999
    MHRA Super Moderator
    8th Jul 2016, 12:51 PM Go to last post

  3. Sticky Thread Sticky: CTA submission now only accepted via Common European Submission Platform (CESP)

    Started by MHRA Super Moderator, 8th Jan 2016 10:30 AM
    • Replies: 0
    • Views: 111,400
    MHRA Super Moderator
    8th Jan 2016, 10:30 AM Go to last post

  4. 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: 113,459
    MHRA Super Moderator
    4th Mar 2016, 01:49 PM Go to last post

  5. Sticky Thread Sticky: MHRA make changes to clinical trials phase I accreditation scheme

    Started by MHRA Super Moderator, 30th Oct 2013 04:30 PM
    • Replies: 0
    • Views: 115,808
    MHRA Super Moderator
    30th Oct 2013, 04:30 PM Go to last post

  1. Moved: SUSARs sent to pharmacies

    Started by Nikki Dewick, 23rd Oct 2015 12:43 PM
    •  
    •  

  2. Moved: Protocol training

    Started by quality234, 29th Jun 2020 08:29 AM
    •  
    •  

  3. Moved: Adverse event before dosing

    Started by quality234, 29th Jun 2020 08:28 AM
    •  
    •  

  4. Moved: SOP Sign off

    Started by Hopkins75, 22nd Jun 2020 01:01 PM
    •  
    •  

  5. Moved: Consent in Emergency Research

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

  6. Moved: Electronic Source Data Access for Monitors and Inspectors

    Started by Mikayala, 16th Nov 2018 09:51 AM
    •  
    •  

  7. Inquiry: Female Partner Pregnancy Reporting in Non-IMP Trials

    Started by Alexander, 31st Mar 2024 03:49 PM
    • Replies: 0
    • Views: 65
    Alexander
    31st Mar 2024, 03:49 PM Go to last post

  8. Moved: clinical trials in homecare pharmacies

    Started by Kiran Bharaj, 23rd Jan 2015 12:59 PM
    •  
    •  

  9. Moved: Exclusion criterion - participation in previous clinical trial within three months

    Started by SRH, 25th Feb 2015 04:19 PM
    •  
    •  

  10. Moved: Medical Images Requirements

    Started by castede1, 22nd Dec 2014 09:17 PM
    •  
    •  

  11. Moved: Restriction on number of screening attempts?

    Started by Kar3n, 17th Feb 2020 10:33 AM
    •  
    •  

  12. Moved: Deleted records by site in error

    Started by blsm002, 22nd Sep 2014 06:49 AM
    •  
    •  

  13. Moved: Exploratory endpoints/ labs: oversight

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

  14. Moved: Redacting patient identifiers for research archiving

    Started by BasseyK, 12th Jun 2019 08:33 AM
    •  
    •  

  15. Moved: Conflict of interest

    Started by debbie.spruce, 13th Feb 2019 11:12 AM
    •  
    •  

  16. Moved: PI has left, no new PI available yet.

    Started by M240484, 1st Feb 2019 07:17 AM
    •  
    •  

  17. Filing of PIS in ISF with original consent

    Started by CarolineC, 18th Aug 2023 03:58 PM
    • Replies: 0
    • Views: 4,345
    CarolineC
    18th Aug 2023, 03:58 PM Go to last post

  18. About Informed Consent Form Lost

    Started by yiyuanzhang, 12th Apr 2023 08:29 AM
    • Replies: 3
    • Views: 5,079
    a123456
    5th May 2023, 03:09 PM Go to last post

  19. Combined TMF/ISF

    Started by Research_Gov, 17th Oct 2023 01:28 PM
    • Replies: 0
    • Views: 5,369
    Research_Gov
    17th Oct 2023, 01:28 PM Go to last post

  20. Site Closure - PI No Longer Available

    Started by s.j.bowden@bham.ac.uk, 21st Dec 2022 11:25 AM
    • Replies: 0
    • Views: 5,675
    s.j.bowden@bham.ac.uk
    21st Dec 2022, 11:25 AM Go to last post

  21. Oxehealth

    Started by Lee Buckley, 28th Nov 2022 12:39 PM
    • Replies: 0
    • Views: 6,739
    Lee Buckley
    28th Nov 2022, 12:39 PM Go to last post

  22. Good clinical practice inspection metrics

    Started by ggittens, 30th Nov 2022 11:02 AM
    • Replies: 1
    • Views: 7,649
    MHRA Moderator
    9th May 2023, 09:51 AM Go to last post

  23. Patient identifiable data and Archiving ISF

    Started by kathy2023, 14th May 2023 07:34 PM
    • Replies: 1
    • Views: 7,982
    a123456
    29th May 2023, 07:19 PM Go to last post

  24. Moved: Clinical trials labels requirements

    Started by martak, 19th Jul 2018 10:13 AM
    •  
    •  

  25. Moved: SDV of data collated into the dose escalation interim report

    Started by celestinehhousel, 26th May 2018 04:20 PM
    •  
    •  

  26. Moved: Interventional clinical trial

    Started by Raju, 14th Aug 2018 04:20 PM
    •  
    •  

  27. Moved: Sunshine Act

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

  28. Moved: Regulations governing Screening studies

    Started by jambun, 27th Feb 2018 12:45 PM
    •  
    •  

  29. Reporting of exploratory endpoints

    Started by ABR, 19th Jan 2023 05:18 PM
    • Replies: 1
    • Views: 9,936
    a123456
    29th Jan 2023, 12:25 PM Go to last post

  30. Moved: Enrollement defintion

    Started by CQAO_GEN, 20th Aug 2018 05:35 PM
    •  
    •  
Page 1 of 2 12 LastLast

Forum information and options

Moderators of this Forum

Thread Display Options

Use this control to limit the display of threads to those newer than the specified time frame.

Allows you to choose the data by which the thread list will be sorted.

Order threads in...

Note: when sorting by date, 'descending order' will show the newest results first.

Icon legend

Contains unread posts
Contains unread posts
Contains no unread posts
Contains no unread posts
More than 15 replies or 150 views
Hot thread with unread posts
More than 15 replies or 150 views
Hot thread with no unread posts
Closed Thread
Thread is closed
Thread Contains a Message Written By You
You have posted in this thread

Posting Permissions

  • You may not post new threads
  • You may not post replies
  • You may not post attachments
  • You may not edit your posts
  •  

Forum Rules