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: 128,969
    MHRA Super Moderator
    2nd May 2013, 03:34 PM Go to last post

  1. Filing in patient notes

    Started by wigs, 9th Feb 2017 04:18 PM
    • Replies: 3
    • Views: 49,883
    a123456
    12th Aug 2021, 10:26 AM Go to last post

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

    Started by M240484, 1st Feb 2019 07:17 AM
    • Replies: 1
    • Views: 49,349
    a123456
    5th Feb 2019, 07:37 PM Go to last post

  3. Sending copies of anonymised consent forms to sponsor

    Started by Trial Manager, 25th Apr 2016 11:23 AM
    • Replies: 3
    • Views: 48,250
    a123456
    7th May 2016, 08:36 AM Go to last post

  4. Patient consented but not randomized - paperwork

    Started by DJH, 22nd Sep 2016 01:41 PM
    • Replies: 3
    • Views: 47,108
    a123456
    6th Mar 2020, 09:58 PM Go to last post

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

    Started by ResearchMW, 5th Nov 2016 12:01 PM
    • Replies: 1
    • Views: 45,835
    Sophie1
    18th May 2021, 05:04 PM Go to last post

  6. Submission of PI for FIH studies application

    Started by Natasha, 29th Jul 2015 10:06 AM
    • Replies: 1
    • Views: 45,032
    MHRA Moderator
    29th Jul 2015, 12:09 PM Go to last post

  7. Destruction of Paper Patient Notes

    Started by kate lees, 26th Jun 2014 08:02 AM
    • Replies: 5
    • Views: 43,887
    MHRA Super Moderator
    25th Feb 2015, 12:15 PM Go to last post

  8. Documenting SAE causality in source data

    Started by ztarfizh, 7th Apr 2014 03:23 PM
    • Replies: 4
    • Views: 43,333
    MHRA Moderator
    6th Aug 2015, 09:51 AM Go to last post

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

    Started by CGW1981, 11th Mar 2016 11:18 AM
    • Replies: 2
    • Views: 40,495
    CGW1981
    22nd Mar 2016, 05:13 PM Go to last post

  10. SDL Delegated Tasks for Research Nurses

    Started by Leigh, 21st Jul 2016 04:14 PM
    • Replies: 2
    • Views: 40,171
    a123456
    3rd Aug 2016, 12:30 PM Go to last post

  11. ECG tracings

    Started by plamb, 15th May 2015 04:47 PM
    • Replies: 1
    • Views: 40,140
    plamb
    21st Oct 2015, 11:33 AM Go to last post

  12. Delegation of electronic training by PI

    Started by ArthurD, 29th Oct 2017 11:12 AM
    • Replies: 0
    • Views: 39,528
    ArthurD
    29th Oct 2017, 11:12 AM Go to last post

  13. 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: 39,386
    a123456
    10th Dec 2018, 04:20 PM Go to last post

  14. Subjects date of consent

    Started by Trialblazer, 7th Aug 2017 02:25 PM
    • Replies: 1
    • Views: 37,288
    a123456
    15th Sep 2017, 07:46 PM Go to last post

  15. Informed consent and safety update

    Started by Kaunas201, 8th Oct 2012 06:53 PM
    • Replies: 0
    • Views: 36,712
    Kaunas201
    8th Oct 2012, 06:53 PM Go to last post

  16. Translator signing ICF as a witness

    Started by MonitorH, 3rd Sep 2012 01:17 PM
    • Replies: 1
    • Views: 33,489
    a123456
    4th Sep 2012, 09:34 AM Go to last post

  17. Source data queries

    Started by ecsy911, 15th Apr 2015 12:07 PM
    • Replies: 2
    • Views: 32,613
    ecsy911
    28th Apr 2015, 09:08 AM Go to last post

  18. Nurse Clinician Causilty assesment

    Started by SW220517, 27th Sep 2017 06:58 PM
    • Replies: 0
    • Views: 32,330
    SW220517
    27th Sep 2017, 06:58 PM Go to last post

  19. SDL Delegated Tasks for Research Nurses

    Started by Leigh, 21st Jul 2016 04:08 PM
    • Replies: 0
    • Views: 32,290
    Leigh
    21st Jul 2016, 04:08 PM Go to last post

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

    Started by TrialsAdvice, 16th Feb 2021 07:06 PM
    • Replies: 2
    • Views: 30,853
    a123456
    6th Jun 2021, 03:06 PM Go to last post

  21. Delegation of Duties

    Started by Jasper, 15th Apr 2012 03:29 PM
    • Replies: 1
    • Views: 30,371
    a123456
    12th May 2013, 07:52 PM Go to last post

  22. Electronic Patient Records

    Started by Jasper, 14th Mar 2012 08:48 PM
    • Replies: 4
    • Views: 26,276
    a123456
    13th Feb 2015, 09:59 PM Go to last post

  23. Informed Consent Forms stored in ISF

    Started by S Townsend, 20th May 2014 10:48 AM
    • Replies: 3
    • Views: 23,489
    a123456
    4th Jun 2014, 06:21 AM Go to last post

  24. source data in maternity study

    Started by CTM_NBT, 21st Apr 2015 01:01 PM
    • Replies: 0
    • Views: 23,266
    CTM_NBT
    21st Apr 2015, 01:01 PM Go to last post

  25. Restriction on number of screening attempts?

    Started by Kar3n, 17th Feb 2020 10:33 AM
    • Replies: 3
    • Views: 21,187
    a123456
    24th Feb 2020, 10:38 AM Go to last post

  26. Delegation log in Pharmacy file

    Started by ilyas ali, 1st Mar 2012 10:41 PM
    • Replies: 4
    • Views: 20,533
    CRA
    24th Apr 2013, 04:48 PM Go to last post

  27. Personally dating documents?

    Started by Kar3n, 23rd Mar 2022 01:18 PM
    • Replies: 2
    • Views: 19,152
    a123456
    26th Mar 2022, 08:34 PM Go to last post

  28. Adverse event before dosing

    Started by quality234, 29th Jun 2020 08:28 AM
    • Replies: 1
    • Views: 18,742
    a123456
    28th Sep 2020, 07:35 PM Go to last post

  29. Electronic consent

    Started by h.williams, 23rd Apr 2012 09:43 AM
    • Replies: 1
    • Views: 18,657
    a123456
    10th Feb 2015, 05:25 PM Go to last post

  30. Responsibility of PI when Study Archived

    Started by kate lees, 26th Jun 2014 08:00 AM
    • Replies: 1
    • Views: 17,740
    a123456
    27th Jun 2014, 10:41 AM Go to last post
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