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: 21,462
    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: 35,186
    11th Jan 2016, 01:27 PM Go to last post
  2. Source Data and CRFs

    Started by sugarg, 28th Nov 2011 10:18 AM
    • Replies: 5
    • Views: 19,660
    2nd Feb 2012, 04:10 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: 18,365
    4th Jan 2013, 01:49 PM Go to last post
  4. PI delegating PI duties?

    Started by MonitorH, 10th May 2013 10:27 AM
    • Replies: 5
    • Views: 23,191
    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: 14,901
    25th Feb 2015, 11:15 AM Go to last post
  6. Electronic Patient Records

    Started by Jasper, 14th Mar 2012 07:48 PM
    • Replies: 4
    • Views: 14,349
    13th Feb 2015, 08:59 PM Go to last post
  7. Delegation log in Pharmacy file

    Started by ilyas ali, 1st Mar 2012 09:41 PM
    • Replies: 4
    • Views: 11,681
    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: 13,672
    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: 15,578
    23rd Dec 2017, 10:20 AM Go to last post
  10. Exclamation Investigator sites losing consent forms

    Started by chrisQA, 21st Aug 2012 11:09 AM
    • Replies: 3
    • Views: 12,198
    23rd Nov 2012, 05:13 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: 9,454
    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: 10,431
    21st Sep 2014, 08:54 PM Go to last post
    • Replies: 3
    • Views: 22,291
    27th Jul 2017, 01:45 PM Go to last post
  13. Medical Images Requirements

    Started by castede1, 22nd Dec 2014 08:17 PM
    • Replies: 3
    • Views: 22,305
    11th Jan 2017, 03:46 AM Go to last post
  14. Reconsenting due to change of PI

    Started by DataAndQualityManager, 14th Apr 2016 07:50 PM
    • Replies: 3
    • Views: 9,159
    22nd Apr 2016, 08:11 AM Go to last post
    • Replies: 3
    • Views: 12,419
    7th May 2016, 08:36 AM Go to last post
  15. Consent for possible future uses of data

    Started by Catherine, 4th Nov 2011 10:35 AM
    • Replies: 2
    • Views: 3,747
    17th Nov 2011, 05:08 PM Go to last post
  16. Scanned Source Documents

    Started by Jasper, 12th Jan 2012 09:37 PM
    • Replies: 2
    • Views: 5,123
    22nd Jun 2012, 05:45 PM Go to last post
  17. Fasting before Consent

    Started by ztarfizh, 26th Nov 2012 10:11 AM
    • Replies: 2
    • Views: 6,548
    27th Nov 2012, 02:58 PM Go to last post
  18. GCP certiifcates for local lab staff

    Started by plamb, 10th Jan 2014 12:11 PM
    • Replies: 2
    • Views: 8,820
    13th Feb 2014, 11:24 AM Go to last post
  19. Deleted records by site in error

    Started by blsm002, 22nd Sep 2014 06:49 AM
    • Replies: 2
    • Views: 21,856
    17th Nov 2014, 07:35 AM Go to last post
  20. Source data queries

    Started by ecsy911, 15th Apr 2015 12:07 PM
    • Replies: 2
    • Views: 9,297
    28th Apr 2015, 09:08 AM Go to last post
    • Replies: 2
    • Views: 11,051
    22nd Mar 2016, 04:13 PM Go to last post
  21. Retrospective Consent for additional samples?

    Started by MsJones, 26th May 2016 10:45 AM
    • Replies: 2
    • Views: 15,001
    1st Jun 2016, 02:33 PM Go to last post
  22. SDL Delegated Tasks for Research Nurses

    Started by Leigh, 21st Jul 2016 04:14 PM
    • Replies: 2
    • Views: 11,312
    3rd Aug 2016, 12:30 PM Go to last post
  23. Filing in patient notes

    Started by wigs, 9th Feb 2017 03:18 PM
    • Replies: 2
    • Views: 6,987
    22nd Feb 2017, 01:49 PM Go to last post
  24. ECG tracings

    Started by plamb, 15th May 2015 04:47 PM
    • Replies: 1
    • Views: 9,272
    21st Oct 2015, 11:33 AM Go to last post
  25. Submission of PI for FIH studies application

    Started by Natasha, 29th Jul 2015 10:06 AM
    • Replies: 1
    • Views: 8,905
    29th Jul 2015, 12:09 PM Go to last post
  26. Missing Medical Notes

    Started by Praseeda12, 16th Dec 2015 02:15 PM
    • Replies: 1
    • Views: 20,747
    17th Dec 2015, 05:00 PM Go to last post
  27. Patient consented but not randomized - paperwork

    Started by DJH, 22nd Sep 2016 01:41 PM
    • Replies: 1
    • Views: 7,877
    23rd Sep 2016, 07:24 AM Go to last post

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