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: 117,592
    MHRA Super Moderator
    2nd May 2013, 03:34 PM Go to last post

  1. ‘Re-consenting’ trial participants

    Started by SRH, 24th May 2012 11:24 AM
    • Replies: 3
    • Views: 143,721
    a123456
    23rd Dec 2017, 11:20 AM Go to last post

  2. Volunteers attending screening but not consenting

    Started by Research Coordinator, 7th Jun 2013 04:01 PM
    • Replies: 1
    • Views: 16,844
    a123456
    11th Jun 2013, 04:30 PM Go to last post

  3. Translator signing ICF as a witness

    Started by MonitorH, 3rd Sep 2012 01:17 PM
    • Replies: 1
    • Views: 28,716
    a123456
    4th Sep 2012, 09:34 AM Go to last post

  4. SUSARs sent to pharmacies

    Started by Nikki Dewick, 23rd Oct 2015 12:43 PM
    • Replies: 0
    • Views: 75,098
    Nikki Dewick
    23rd Oct 2015, 12:43 PM Go to last post

  5. Submission of PI for FIH studies application

    Started by Natasha, 29th Jul 2015 10:06 AM
    • Replies: 1
    • Views: 43,932
    MHRA Moderator
    29th Jul 2015, 12:09 PM Go to last post

  6. Subjects date of consent

    Started by Trialblazer, 7th Aug 2017 02:25 PM
    • Replies: 1
    • Views: 35,025
    a123456
    15th Sep 2017, 07:46 PM Go to last post

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

    Started by smezzian, 19th Jul 2021 06:25 PM
    • Replies: 1
    • Views: 14,929
    a123456
    5th Aug 2021, 03:08 PM Go to last post

  8. Source data queries

    Started by ecsy911, 15th Apr 2015 12:07 PM
    • Replies: 2
    • Views: 31,505
    ecsy911
    28th Apr 2015, 09:08 AM Go to last post

  9. source data in maternity study

    Started by CTM_NBT, 21st Apr 2015 01:01 PM
    • Replies: 0
    • Views: 22,475
    CTM_NBT
    21st Apr 2015, 01:01 PM Go to last post

  10. Source Data and CRFs

    Started by sugarg, 28th Nov 2011 11:18 AM
    • Replies: 5
    • Views: 111,023
    sugarg
    2nd Feb 2012, 05:10 PM Go to last post

  11. SIV documents_SIV attendance log and training log

    Started by elena123, 2nd Dec 2016 12:11 PM
    • Replies: 0
    • Views: 53,364
    elena123
    2nd Dec 2016, 12:11 PM Go to last post

  12. Wink Site Signature and Delegation Logs

    Started by qalassinoz, 29th Mar 2012 07:17 AM
    2 Pages •
    1 2
    • Replies: 13
    • Views: 274,626
    a123456
    16th Feb 2023, 05:24 PM 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: 37,345
    a123456
    10th Dec 2018, 04:20 PM Go to last post

  14. Sending copies of anonymised consent forms to sponsor

    Started by Trial Manager, 25th Apr 2016 11:23 AM
    • Replies: 3
    • Views: 45,928
    a123456
    7th May 2016, 08:36 AM Go to last post

  15. SDL Delegated Tasks for Research Nurses

    Started by Leigh, 21st Jul 2016 04:08 PM
    • Replies: 0
    • Views: 30,456
    Leigh
    21st Jul 2016, 04:08 PM Go to last post

  16. SDL Delegated Tasks for Research Nurses

    Started by Leigh, 21st Jul 2016 04:14 PM
    • Replies: 2
    • Views: 37,931
    a123456
    3rd Aug 2016, 12:30 PM Go to last post

  17. Scanned Source Documents

    Started by Jasper, 12th Jan 2012 10:37 PM
    • Replies: 2
    • Views: 11,203
    a123456
    22nd Jun 2012, 05:45 PM Go to last post

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

    Started by TrialsAdvice, 16th Feb 2021 07:06 PM
    • Replies: 2
    • Views: 29,480
    a123456
    6th Jun 2021, 03:06 PM Go to last post

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

    Started by CGW1981, 11th Mar 2016 11:18 AM
    • Replies: 2
    • Views: 38,561
    CGW1981
    22nd Mar 2016, 05:13 PM Go to last post

  20. Retrospective Consent for additional samples?

    Started by MsJones, 26th May 2016 10:45 AM
    • Replies: 2
    • Views: 55,182
    MsJones
    1st Jun 2016, 02:33 PM Go to last post

  21. Restriction on number of screening attempts?

    Started by Kar3n, 17th Feb 2020 10:33 AM
    • Replies: 3
    • Views: 18,523
    a123456
    24th Feb 2020, 10:38 AM Go to last post

  22. Responsibility of PI when Study Archived

    Started by kate lees, 26th Jun 2014 08:00 AM
    • Replies: 1
    • Views: 17,300
    a123456
    27th Jun 2014, 10:41 AM Go to last post

  23. Reporting of Race and Ethnicity

    Started by David, 15th Feb 2012 04:09 PM
    • Replies: 1
    • Views: 11,662
    a123456
    1st Sep 2012, 11:25 AM Go to last post

  24. Reimbursement for patients time

    Started by klapsa, 27th Feb 2014 02:49 PM
    • Replies: 1
    • Views: 12,703
    a123456
    27th Feb 2014, 05:37 PM Go to last post

  25. Redacted source documents

    Started by NAdey, 23rd Oct 2019 10:05 AM
    • Replies: 1
    • Views: 49,621
    a123456
    24th Oct 2019, 08:06 PM Go to last post

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

    Started by ResearchMW, 5th Nov 2016 12:01 PM
    • Replies: 1
    • Views: 43,811
    Sophie1
    18th May 2021, 05:04 PM Go to last post

  27. Reconsenting due to change of PI

    Started by DataAndQualityManager, 14th Apr 2016 07:50 PM
    • Replies: 3
    • Views: 85,674
    a123456
    22nd Apr 2016, 08:11 AM Go to last post

  28. Pregnancy testing not included in the protocol

    Started by lilo1929, 30th Mar 2015 03:41 PM
    • Replies: 0
    • Views: 11,732
    lilo1929
    30th Mar 2015, 03:41 PM Go to last post

  29. PI signature on Delegation of authority log

    Started by disalaf42, 28th Nov 2019 02:21 PM
    • Replies: 1
    • Views: 82,143
    a123456
    2nd Dec 2019, 09:10 PM Go to last post

  30. PI Responsibilities & Long term sick leave

    Started by Cameron Glen, 12th Aug 2014 08:55 AM
    • Replies: 3
    • Views: 107,049
    a123456
    21st Sep 2014, 08:54 PM Go to last post
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