Good Clinical Practice Guide
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Forum: Investigator Sites (inc Principal Investigator responsibilities, consent, source data and CRFs)

  1. Sticky Thread Sticky: MHRA produced FAQs for Investigator Sites

    Started by MHRA Super Moderator, 14th Oct 2011 10:58 AM
    • Replies: 4
    • Views: 119,940
    MHRA Super Moderator
    2nd May 2013, 03:34 PM Go to last post

  1. Patient Confidentiality and Data Protection

    Started by E.Atkin, 8th May 2013 11:04 AM
    • Replies: 1
    • Views: 15,780
    a123456
    10th May 2013, 10:13 AM Go to last post

  2. Defintion of EAG type trial (Expert Advisory Group)

    Started by drlyncorry, 8th Mar 2023 02:54 PM
    • Replies: 0
    • Views: 9,910
    drlyncorry
    8th Mar 2023, 02:54 PM Go to last post

  3. Patient consented but not randomized - paperwork

    Started by DJH, 22nd Sep 2016 01:41 PM
    • Replies: 3
    • Views: 45,227
    a123456
    6th Mar 2020, 09:58 PM Go to last post

  4. PI signature on Delegation of authority log

    Started by disalaf42, 28th Nov 2019 02:21 PM
    • Replies: 1
    • Views: 83,430
    a123456
    2nd Dec 2019, 09:10 PM Go to last post

  5. Conflict of interest

    Started by debbie.spruce, 13th Feb 2019 11:12 AM
    • Replies: 2
    • Views: 56,572
    debbie.spruce
    18th Feb 2019, 12:14 PM Go to last post

  6. Reporting of Race and Ethnicity

    Started by David, 15th Feb 2012 04:09 PM
    • Replies: 1
    • Views: 11,734
    a123456
    1st Sep 2012, 11:25 AM Go to last post

  7. Reconsenting due to change of PI

    Started by DataAndQualityManager, 14th Apr 2016 07:50 PM
    • Replies: 3
    • Views: 87,633
    a123456
    22nd Apr 2016, 08:11 AM Go to last post

  8. source data in maternity study

    Started by CTM_NBT, 21st Apr 2015 01:01 PM
    • Replies: 0
    • Views: 22,643
    CTM_NBT
    21st Apr 2015, 01:01 PM Go to last post

  9. Electronic Delegation Logs

    Started by CRA_SouthLondon, 29th Nov 2018 02:50 PM
    • Replies: 1
    • Views: 77,871
    a123456
    10th Dec 2018, 04:02 PM Go to last post

  10. Exclamation Investigator sites losing consent forms

    Started by chrisQA, 21st Aug 2012 11:09 AM
    • Replies: 3
    • Views: 111,778
    MHRA Moderator
    23rd Nov 2012, 06:13 PM Go to last post

  11. Question Return of consent forms by post (CTIMP in rare disease area)

    Started by CGW1981, 11th Mar 2016 11:18 AM
    • Replies: 2
    • Views: 39,000
    CGW1981
    22nd Mar 2016, 05:13 PM Go to last post

  12. Consent for possible future uses of data

    Started by Catherine, 4th Nov 2011 11:35 AM
    • Replies: 2
    • Views: 7,829
    Rob Wosley
    17th Nov 2011, 06:08 PM Go to last post

  13. Medical Images Requirements

    Started by castede1, 22nd Dec 2014 09:17 PM
    • Replies: 3
    • Views: 83,434
    lehoangrose
    11th Jan 2017, 04:46 AM Go to last post

  14. Question Data Archival Requirements

    Started by castede1, 7th Jan 2015 07:25 PM
    • Replies: 0
    • Views: 12,003
    castede1
    7th Jan 2015, 07:25 PM Go to last post

  15. Negative evidence reported in study patient's medical records

    Started by carole, 18th Jun 2012 11:26 AM
    • Replies: 0
    • Views: 5,961
    carole
    18th Jun 2012, 11:26 AM Go to last post

  16. Patient transferring site - Who keeps original trial docs?

    Started by CaraF, 26th Jul 2022 02:54 PM
    • Replies: 1
    • Views: 12,744
    a123456
    31st Jul 2022, 06:18 PM Go to last post

  17. PI Responsibilities & Long term sick leave

    Started by Cameron Glen, 12th Aug 2014 08:55 AM
    • Replies: 3
    • Views: 109,696
    a123456
    21st Sep 2014, 08:54 PM Go to last post

  18. Deleted records by site in error

    Started by blsm002, 22nd Sep 2014 06:49 AM
    • Replies: 2
    • Views: 77,133
    Vyara Stefanova
    17th Nov 2014, 08:35 AM Go to last post

  19. Delegation of electronic training by PI

    Started by ArthurD, 29th Oct 2017 11:12 AM
    • Replies: 0
    • Views: 37,891
    ArthurD
    29th Oct 2017, 11:12 AM Go to last post

  20. Physician Associates and Nurse Practitioners

    Started by Amanda Hensby, 28th Jun 2022 11:29 AM
    • Replies: 0
    • Views: 5,211
    Amanda Hensby
    28th Jun 2022, 11:29 AM Go to last post
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