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: 46,618
    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: 11
    • Views: 88,909
    11th Jan 2016, 02:27 PM Go to last post
  2. ‘Re-consenting’ trial participants

    Started by SRH, 24th May 2012 11:24 AM
    • Replies: 3
    • Views: 78,180
    23rd Dec 2017, 11:20 AM Go to last post
  3. Medical Images Requirements

    Started by castede1, 22nd Dec 2014 09:17 PM
    • Replies: 3
    • Views: 64,166
    11th Jan 2017, 04:46 AM Go to last post
  4. Deleted records by site in error

    Started by blsm002, 22nd Sep 2014 06:49 AM
    • Replies: 2
    • Views: 59,130
    17th Nov 2014, 08:35 AM Go to last post
  5. SUSARs sent to pharmacies

    Started by Nikki Dewick, 23rd Oct 2015 12:43 PM
    • Replies: 0
    • Views: 58,211
    23rd Oct 2015, 12:43 PM Go to last post
  6. Consent in Emergency Research

    Started by Hugh Davies, 2nd Oct 2012 02:41 PM
    • Replies: 1
    • Views: 56,016
    4th Oct 2012, 01:33 PM Go to last post
  7. clinical trials in homecare pharmacies

    Started by Kiran Bharaj, 23rd Jan 2015 12:59 PM
    • Replies: 0
    • Views: 54,740
    23rd Jan 2015, 12:59 PM Go to last post
    • Replies: 0
    • Views: 50,037
    25th Feb 2015, 04:19 PM Go to last post
  8. New PI delegation

    Started by Kristga, 24th Apr 2018 02:33 PM
    • Replies: 1
    • Views: 47,994
    10th Dec 2018, 04:36 PM Go to last post
    • Replies: 3
    • Views: 45,680
    27th Jul 2017, 01:45 PM Go to last post
  9. Missing Medical Notes

    Started by Praseeda12, 16th Dec 2015 03:15 PM
    • Replies: 1
    • Views: 41,765
    17th Dec 2015, 06:00 PM Go to last post
  10. Source Data and CRFs

    Started by sugarg, 28th Nov 2011 11:18 AM
    • Replies: 5
    • Views: 39,084
    2nd Feb 2012, 05:10 PM Go to last post
  11. Retrospective Consent for additional samples?

    Started by MsJones, 26th May 2016 10:45 AM
    • Replies: 2
    • Views: 36,373
    1st Jun 2016, 02:33 PM Go to last post
  12. Investigator CVs and GCP training

    Started by Speediepup, 2nd Jan 2014 03:35 PM
    • Replies: 1
    • Views: 36,203
    4th Jan 2014, 12:46 PM Go to last post
  13. PI delegating PI duties?

    Started by MonitorH, 10th May 2013 10:27 AM
    • Replies: 5
    • Views: 35,283
    25th Sep 2014, 05:33 PM Go to last post
  14. Conflict of interest

    Started by debbie.spruce, 13th Feb 2019 11:12 AM
    • Replies: 2
    • Views: 34,186
    18th Feb 2019, 12:14 PM Go to last post
  15. Documenting SAE causality in source data

    Started by ztarfizh, 7th Apr 2014 03:23 PM
    • Replies: 4
    • Views: 32,892
    6th Aug 2015, 09:51 AM Go to last post
    • Replies: 3
    • Views: 32,220
    7th May 2016, 08:36 AM Go to last post
  16. Filing in patient notes

    Started by wigs, 9th Feb 2017 04:18 PM
    • Replies: 3
    • Views: 31,911
    12th Aug 2021, 10:26 AM Go to last post
  17. Completing a 1572

    Started by nick dance, 7th Feb 2019 03:32 PM
    • Replies: 1
    • Views: 31,649
    8th Feb 2019, 10:25 AM Go to last post
  18. Reconsenting due to change of PI

    Started by DataAndQualityManager, 14th Apr 2016 07:50 PM
    • Replies: 3
    • Views: 31,516
    22nd Apr 2016, 08:11 AM Go to last post
  19. Submission of PI for FIH studies application

    Started by Natasha, 29th Jul 2015 10:06 AM
    • Replies: 1
    • Views: 30,125
    29th Jul 2015, 12:09 PM Go to last post
    • Replies: 2
    • Views: 29,347
    22nd Mar 2016, 05:13 PM Go to last post
  20. Patient consented but not randomized - paperwork

    Started by DJH, 22nd Sep 2016 01:41 PM
    • Replies: 3
    • Views: 29,252
    6th Mar 2020, 09:58 PM Go to last post
  21. ECG tracings

    Started by plamb, 15th May 2015 04:47 PM
    • Replies: 1
    • Views: 28,890
    21st Oct 2015, 11:33 AM Go to last post
    • Replies: 8
    • Views: 28,741
    7th Feb 2021, 07:48 PM Go to last post
  22. Electronic Delegation Logs

    Started by CRA_SouthLondon, 29th Nov 2018 02:50 PM
    • Replies: 1
    • Views: 28,741
    10th Dec 2018, 04:02 PM Go to last post
  23. Consent Form advice please

    Started by ldunham, 15th Nov 2017 06:02 PM
    • Replies: 1
    • Views: 28,694
    18th Dec 2019, 03:47 PM Go to last post
  24. SDL Delegated Tasks for Research Nurses

    Started by Leigh, 21st Jul 2016 04:14 PM
    • Replies: 2
    • Views: 28,366
    3rd Aug 2016, 12:30 PM Go to last post
  25. PI has left, no new PI available yet.

    Started by M240484, 1st Feb 2019 07:17 AM
    • Replies: 1
    • Views: 28,253
    5th Feb 2019, 07:37 PM Go to last post

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