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: 31,256
    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: 56,482
    11th Jan 2016, 02:27 PM Go to last post
    • Replies: 8
    • Views: 11,827
    7th Feb 2021, 07:48 PM Go to last post
  2. Source Data and CRFs

    Started by sugarg, 28th Nov 2011 11:18 AM
    • Replies: 5
    • Views: 34,168
    2nd Feb 2012, 05:10 PM Go to last post
  3. Filing signed informed consent forms in site file

    Started by plamb, 24th Aug 2012 04:26 PM
    • Replies: 5
    • Views: 23,736
    4th Jan 2013, 02:49 PM Go to last post
  4. PI delegating PI duties?

    Started by MonitorH, 10th May 2013 10:27 AM
    • Replies: 5
    • Views: 31,088
    25th Sep 2014, 05:33 PM Go to last post
  5. Destruction of Paper Patient Notes

    Started by kate lees, 26th Jun 2014 08:02 AM
    • Replies: 5
    • Views: 19,433
    25th Feb 2015, 12:15 PM Go to last post
  6. Electronic Patient Records

    Started by Jasper, 14th Mar 2012 08:48 PM
    • Replies: 4
    • Views: 18,244
    13th Feb 2015, 09:59 PM Go to last post
  7. Delegation log in Pharmacy file

    Started by ilyas ali, 1st Mar 2012 10:41 PM
    • Replies: 4
    • Views: 15,243
    24th Apr 2013, 04:48 PM Go to last post
  8. Documenting SAE causality in source data

    Started by ztarfizh, 7th Apr 2014 03:23 PM
    • Replies: 4
    • Views: 21,637
    6th Aug 2015, 09:51 AM Go to last post
  9. ‘Re-consenting’ trial participants

    Started by SRH, 24th May 2012 11:24 AM
    • Replies: 3
    • Views: 36,228
    23rd Dec 2017, 11:20 AM Go to last post
  10. Exclamation Investigator sites losing consent forms

    Started by chrisQA, 21st Aug 2012 11:09 AM
    • Replies: 3
    • Views: 20,379
    23rd Nov 2012, 06:13 PM Go to last post
  11. Informed Consent Forms stored in ISF

    Started by S Townsend, 20th May 2014 10:48 AM
    • Replies: 3
    • Views: 12,408
    4th Jun 2014, 06:21 AM Go to last post
  12. PI Responsibilities & Long term sick leave

    Started by Cameron Glen, 12th Aug 2014 08:55 AM
    • Replies: 3
    • Views: 14,512
    21st Sep 2014, 08:54 PM Go to last post
    • Replies: 3
    • Views: 31,683
    27th Jul 2017, 01:45 PM Go to last post
  13. Medical Images Requirements

    Started by castede1, 22nd Dec 2014 09:17 PM
    • Replies: 3
    • Views: 38,724
    11th Jan 2017, 04:46 AM Go to last post
  14. Restriction on number of screening attempts?

    Started by Kar3n, 17th Feb 2020 10:33 AM
    • Replies: 3
    • Views: 4,676
    24th Feb 2020, 10:38 AM Go to last post
  15. Reconsenting due to change of PI

    Started by DataAndQualityManager, 14th Apr 2016 07:50 PM
    • Replies: 3
    • Views: 18,125
    22nd Apr 2016, 08:11 AM Go to last post
    • Replies: 3
    • Views: 20,135
    7th May 2016, 08:36 AM Go to last post
  16. Patient consented but not randomized - paperwork

    Started by DJH, 22nd Sep 2016 01:41 PM
    • Replies: 3
    • Views: 16,046
    6th Mar 2020, 09:58 PM Go to last post
  17. Filing in patient notes

    Started by wigs, 9th Feb 2017 04:18 PM
    • Replies: 3
    • Views: 15,803
    12th Aug 2021, 10:26 AM Go to last post
  18. Consent for possible future uses of data

    Started by Catherine, 4th Nov 2011 11:35 AM
    • Replies: 2
    • Views: 5,751
    17th Nov 2011, 06:08 PM Go to last post
  19. Scanned Source Documents

    Started by Jasper, 12th Jan 2012 10:37 PM
    • Replies: 2
    • Views: 8,414
    22nd Jun 2012, 05:45 PM Go to last post
  20. Fasting before Consent

    Started by ztarfizh, 26th Nov 2012 11:11 AM
    • Replies: 2
    • Views: 9,705
    27th Nov 2012, 03:58 PM Go to last post
  21. GCP certiifcates for local lab staff

    Started by plamb, 10th Jan 2014 01:11 PM
    • Replies: 2
    • Views: 11,333
    13th Feb 2014, 12:24 PM Go to last post
  22. Deleted records by site in error

    Started by blsm002, 22nd Sep 2014 06:49 AM
    • Replies: 2
    • Views: 36,436
    17th Nov 2014, 08:35 AM Go to last post
  23. Source data queries

    Started by ecsy911, 15th Apr 2015 12:07 PM
    • Replies: 2
    • Views: 14,950
    28th Apr 2015, 09:08 AM Go to last post
  24. Retrospective Consent for additional samples?

    Started by MsJones, 26th May 2016 10:45 AM
    • Replies: 2
    • Views: 22,844
    1st Jun 2016, 02:33 PM Go to last post
  25. Duration of informed consent after death

    Started by ztarfizh, 31st Jan 2020 01:29 PM
    • Replies: 2
    • Views: 2,222
    18th Feb 2020, 08:08 PM Go to last post
  26. SDL Delegated Tasks for Research Nurses

    Started by Leigh, 21st Jul 2016 04:14 PM
    • Replies: 2
    • Views: 17,781
    3rd Aug 2016, 12:30 PM Go to last post
  27. Conflict of interest

    Started by debbie.spruce, 13th Feb 2019 11:12 AM
    • Replies: 2
    • Views: 13,430
    18th Feb 2019, 12:14 PM Go to last post

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