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: 173,182
    MHRA Super Moderator
    2nd May 2013, 03:34 PM Go to last post

  1. Question Availability of unblinded treatment allocation

    Started by 20349546, 21st Nov 2024 07:15 AM
    • Replies: 1
    • Views: 25,301
    Margit Zehrer
    31st Jan 2025, 04:10 PM Go to last post

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

    Started by drlyncorry, 8th Mar 2023 02:54 PM
    • Replies: 1
    • Views: 41,981
    20349546
    21st Nov 2024, 07:28 AM Go to last post

  3. Question PI Oversight of sponsor vendor staff for DCT Teleheath elements on a CTIMP.

    Started by PedanticResearcher, 4th Sep 2024 05:04 PM
    • Replies: 2
    • Views: 20,850
    a123456
    13th Oct 2024, 11:30 AM Go to last post

  4. PI oversight of trials with central pharmacy

    Started by RFay, 24th Aug 2023 02:53 PM
    • Replies: 2
    • Views: 30,714
    a123456
    18th Sep 2024, 10:28 AM Go to last post

  5. Wink Site Signature and Delegation Logs

    Started by qalassinoz, 29th Mar 2012 07:17 AM
    2 Pages •
    1 2
    • Replies: 13
    • Views: 382,684
    a123456
    16th Feb 2023, 05:24 PM Go to last post

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

    Started by CaraF, 26th Jul 2022 02:54 PM
    • Replies: 1
    • Views: 38,733
    a123456
    31st Jul 2022, 06:18 PM Go to last post

  7. Physician Associates and Nurse Practitioners

    Started by Amanda Hensby, 28th Jun 2022 11:29 AM
    • Replies: 0
    • Views: 24,787
    Amanda Hensby
    28th Jun 2022, 11:29 AM Go to last post

  8. Personally dating documents?

    Started by Kar3n, 23rd Mar 2022 01:18 PM
    • Replies: 2
    • Views: 44,098
    a123456
    26th Mar 2022, 08:34 PM Go to last post

  9. Filing in patient notes

    Started by wigs, 9th Feb 2017 04:18 PM
    • Replies: 3
    • Views: 76,534
    a123456
    12th Aug 2021, 10:26 AM Go to last post

  10. Sub/Co-Investigator absence and delegation of authority

    Started by smezzian, 19th Jul 2021 06:25 PM
    • Replies: 1
    • Views: 39,458
    a123456
    5th Aug 2021, 03:08 PM Go to last post

  11. Same person acting as both sponsor AND site staff - inappropriate?

    Started by TrialsAdvice, 16th Feb 2021 07:06 PM
    • Replies: 2
    • Views: 59,855
    a123456
    6th Jun 2021, 03:06 PM Go to last post

  12. Recording of consent - what should be written in patient notes?

    Started by ResearchMW, 5th Nov 2016 12:01 PM
    • Replies: 1
    • Views: 73,362
    Sophie1
    18th May 2021, 05:04 PM Go to last post

  13. Electronic Source Data Access for Monitors and Inspectors

    Started by Mikayala, 9th Oct 2018 10:04 AM
    • Replies: 8
    • Views: 79,443
    a123456
    7th Feb 2021, 07:48 PM Go to last post

  14. Delegation log- CVs and GCP certificates

    Started by sab14, 16th Oct 2020 04:11 PM
    • Replies: 1
    • Views: 40,194
    a123456
    18th Jan 2021, 04:22 PM Go to last post

  15. Adverse event before dosing

    Started by quality234, 29th Jun 2020 08:28 AM
    • Replies: 1
    • Views: 47,816
    a123456
    28th Sep 2020, 07:35 PM Go to last post

  16. Patient consented but not randomized - paperwork

    Started by DJH, 22nd Sep 2016 01:41 PM
    • Replies: 3
    • Views: 70,404
    a123456
    6th Mar 2020, 09:58 PM Go to last post

  17. Restriction on number of screening attempts?

    Started by Kar3n, 17th Feb 2020 10:33 AM
    • Replies: 3
    • Views: 51,802
    a123456
    24th Feb 2020, 10:38 AM Go to last post

  18. Duration of informed consent after death

    Started by ztarfizh, 31st Jan 2020 01:29 PM
    • Replies: 2
    • Views: 35,661
    a123456
    18th Feb 2020, 08:08 PM Go to last post

  19. Consent Form advice please

    Started by ldunham, 15th Nov 2017 06:02 PM
    • Replies: 1
    • Views: 157,176
    a123456
    18th Dec 2019, 03:47 PM Go to last post

  20. PI signature on Delegation of authority log

    Started by disalaf42, 28th Nov 2019 02:21 PM
    • Replies: 1
    • Views: 119,975
    a123456
    2nd Dec 2019, 09:10 PM Go to last post

  21. Redacted source documents

    Started by NAdey, 23rd Oct 2019 10:05 AM
    • Replies: 1
    • Views: 79,624
    a123456
    24th Oct 2019, 08:06 PM Go to last post

  22. Conflict of interest

    Started by debbie.spruce, 13th Feb 2019 11:12 AM
    • Replies: 2
    • Views: 91,474
    debbie.spruce
    18th Feb 2019, 12:14 PM Go to last post

  23. Completing a 1572

    Started by nick dance, 7th Feb 2019 03:32 PM
    • Replies: 1
    • Views: 204,682
    a123456
    8th Feb 2019, 10:25 AM Go to last post

  24. PI has left, no new PI available yet.

    Started by M240484, 1st Feb 2019 07:17 AM
    • Replies: 1
    • Views: 74,060
    a123456
    5th Feb 2019, 07:37 PM Go to last post

  25. New PI delegation

    Started by Kristga, 24th Apr 2018 02:33 PM
    • Replies: 1
    • Views: 99,305
    a123456
    10th Dec 2018, 04:36 PM Go to last post

  26. Should people carrying out their normal clinical role be added to Delegation Log

    Started by Patricia, 18th Oct 2018 02:48 PM
    • Replies: 1
    • Views: 61,813
    a123456
    10th Dec 2018, 04:20 PM Go to last post

  27. Electronic Delegation Logs

    Started by CRA_SouthLondon, 29th Nov 2018 02:50 PM
    • Replies: 1
    • Views: 117,574
    a123456
    10th Dec 2018, 04:02 PM Go to last post

  28. ‘Re-consenting’ trial participants

    Started by SRH, 24th May 2012 11:24 AM
    • Replies: 3
    • Views: 194,988
    a123456
    23rd Dec 2017, 11:20 AM Go to last post

  29. Delegation of electronic training by PI

    Started by ArthurD, 29th Oct 2017 11:12 AM
    • Replies: 0
    • Views: 63,891
    ArthurD
    29th Oct 2017, 11:12 AM Go to last post

  30. Nurse Clinician Causilty assesment

    Started by SW220517, 27th Sep 2017 06:58 PM
    • Replies: 0
    • Views: 58,223
    SW220517
    27th Sep 2017, 06:58 PM Go to last post
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