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: 118,048
    MHRA Super Moderator
    2nd May 2013, 03:34 PM Go to last post

  1. Wink Site Signature and Delegation Logs

    Started by qalassinoz, 29th Mar 2012 07:17 AM
    2 Pages •
    1 2
    • Replies: 13
    • Views: 275,499
    a123456
    16th Feb 2023, 05:24 PM Go to last post

  2. Investigator CVs and GCP training

    Started by Speediepup, 2nd Jan 2014 03:35 PM
    • Replies: 1
    • Views: 169,747
    a123456
    4th Jan 2014, 12:46 PM Go to last post

  3. ‘Re-consenting’ trial participants

    Started by SRH, 24th May 2012 11:24 AM
    • Replies: 3
    • Views: 144,115
    a123456
    23rd Dec 2017, 11:20 AM Go to last post

  4. Completing a 1572

    Started by nick dance, 7th Feb 2019 03:32 PM
    • Replies: 1
    • Views: 140,591
    a123456
    8th Feb 2019, 10:25 AM Go to last post

  5. Source Data and CRFs

    Started by sugarg, 28th Nov 2011 11:18 AM
    • Replies: 5
    • Views: 111,266
    sugarg
    2nd Feb 2012, 05:10 PM Go to last post

  6. Exclamation Investigator sites losing consent forms

    Started by chrisQA, 21st Aug 2012 11:09 AM
    • Replies: 3
    • Views: 110,148
    MHRA Moderator
    23rd Nov 2012, 06:13 PM Go to last post

  7. PI Responsibilities & Long term sick leave

    Started by Cameron Glen, 12th Aug 2014 08:55 AM
    • Replies: 3
    • Views: 107,563
    a123456
    21st Sep 2014, 08:54 PM Go to last post

  8. Consent Form advice please

    Started by ldunham, 15th Nov 2017 06:02 PM
    • Replies: 1
    • Views: 98,129
    a123456
    18th Dec 2019, 03:47 PM Go to last post

  9. Reconsenting due to change of PI

    Started by DataAndQualityManager, 14th Apr 2016 07:50 PM
    • Replies: 3
    • Views: 86,062
    a123456
    22nd Apr 2016, 08:11 AM Go to last post

  10. PI delegating PI duties?

    Started by MonitorH, 10th May 2013 10:27 AM
    • Replies: 5
    • Views: 83,592
    a123456
    25th Sep 2014, 05:33 PM Go to last post

  11. If there's no acting Principal Investigator....

    Started by Federica Bitonti, 26th Jun 2015 03:04 PM
    • Replies: 3
    • Views: 83,215
    CQAO_GEN
    27th Jul 2017, 01:45 PM Go to last post

  12. Medical Images Requirements

    Started by castede1, 22nd Dec 2014 09:17 PM
    • Replies: 3
    • Views: 82,792
    lehoangrose
    11th Jan 2017, 04:46 AM Go to last post

  13. PI signature on Delegation of authority log

    Started by disalaf42, 28th Nov 2019 02:21 PM
    • Replies: 1
    • Views: 82,395
    a123456
    2nd Dec 2019, 09:10 PM Go to last post

  14. Deleted records by site in error

    Started by blsm002, 22nd Sep 2014 06:49 AM
    • Replies: 2
    • Views: 76,666
    Vyara Stefanova
    17th Nov 2014, 08:35 AM Go to last post

  15. Electronic Delegation Logs

    Started by CRA_SouthLondon, 29th Nov 2018 02:50 PM
    • Replies: 1
    • Views: 76,524
    a123456
    10th Dec 2018, 04:02 PM Go to last post

  16. SUSARs sent to pharmacies

    Started by Nikki Dewick, 23rd Oct 2015 12:43 PM
    • Replies: 0
    • Views: 75,217
    Nikki Dewick
    23rd Oct 2015, 12:43 PM Go to last post

  17. clinical trials in homecare pharmacies

    Started by Kiran Bharaj, 23rd Jan 2015 12:59 PM
    • Replies: 0
    • Views: 71,453
    Kiran Bharaj
    23rd Jan 2015, 12:59 PM Go to last post

  18. Medical Qualifications of Sub-Investigators

    Started by HelenWood, 16th Mar 2015 10:25 AM
    • Replies: 1
    • Views: 71,045
    a123456
    17th Mar 2015, 08:34 AM Go to last post

  19. Consent in Emergency Research

    Started by Hugh Davies, 2nd Oct 2012 02:41 PM
    • Replies: 1
    • Views: 70,874
    MHRA Moderator
    4th Oct 2012, 01:33 PM Go to last post

  20. New PI delegation

    Started by Kristga, 24th Apr 2018 02:33 PM
    • Replies: 1
    • Views: 69,885
    a123456
    10th Dec 2018, 04:36 PM Go to last post

  21. Exclusion criterion - participation in previous clinical trial within three months

    Started by SRH, 25th Feb 2015 04:19 PM
    • Replies: 0
    • Views: 64,056
    SRH
    25th Feb 2015, 04:19 PM Go to last post

  22. Filing signed informed consent forms in site file

    Started by plamb, 24th Aug 2012 04:26 PM
    • Replies: 5
    • Views: 60,251
    G&T
    4th Jan 2013, 02:49 PM Go to last post

  23. Conflict of interest

    Started by debbie.spruce, 13th Feb 2019 11:12 AM
    • Replies: 2
    • Views: 56,014
    debbie.spruce
    18th Feb 2019, 12:14 PM Go to last post

  24. Retrospective Consent for additional samples?

    Started by MsJones, 26th May 2016 10:45 AM
    • Replies: 2
    • Views: 55,306
    MsJones
    1st Jun 2016, 02:33 PM Go to last post

  25. SIV documents_SIV attendance log and training log

    Started by elena123, 2nd Dec 2016 12:11 PM
    • Replies: 0
    • Views: 53,660
    elena123
    2nd Dec 2016, 12:11 PM Go to last post

  26. Missing Medical Notes

    Started by Praseeda12, 16th Dec 2015 03:15 PM
    • Replies: 1
    • Views: 53,030
    a123456
    17th Dec 2015, 06:00 PM Go to last post

  27. Fasting before Consent

    Started by ztarfizh, 26th Nov 2012 11:11 AM
    • Replies: 2
    • Views: 52,286
    a123456
    27th Nov 2012, 03:58 PM Go to last post

  28. Redacted source documents

    Started by NAdey, 23rd Oct 2019 10:05 AM
    • Replies: 1
    • Views: 49,795
    a123456
    24th Oct 2019, 08:06 PM Go to last post

  29. Electronic Source Data Access for Monitors and Inspectors

    Started by Mikayala, 9th Oct 2018 10:04 AM
    • Replies: 8
    • Views: 49,534
    a123456
    7th Feb 2021, 07:48 PM Go to last post

  30. Question Independent Nurse Prescribers in Clinical Trials

    Started by Jasper, 17th Jul 2013 09:43 PM
    • Replies: 1
    • Views: 47,398
    a123456
    19th Jul 2013, 08:00 PM Go to last post
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