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: 23,482
    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: 18,726
    23rd Dec 2017, 11:20 AM Go to last post
    • Replies: 1
    • Views: 10,739
    11th Jun 2013, 04:30 PM Go to last post
  2. Translator signing ICF as a witness

    Started by MonitorH, 3rd Sep 2012 01:17 PM
    • Replies: 1
    • Views: 5,680
    4th Sep 2012, 09:34 AM Go to last post
  3. SUSARs sent to pharmacies

    Started by Nikki Dewick, 23rd Oct 2015 12:43 PM
    • Replies: 0
    • Views: 23,795
    23rd Oct 2015, 12:43 PM Go to last post
  4. Submission of PI for FIH studies application

    Started by Natasha, 29th Jul 2015 10:06 AM
    • Replies: 1
    • Views: 10,024
    29th Jul 2015, 12:09 PM Go to last post
  5. Subjects date of consent

    Started by Trialblazer, 7th Aug 2017 02:25 PM
    • Replies: 1
    • Views: 4,267
    15th Sep 2017, 07:46 PM Go to last post
  6. Source data queries

    Started by ecsy911, 15th Apr 2015 12:07 PM
    • Replies: 2
    • Views: 10,262
    28th Apr 2015, 09:08 AM Go to last post
  7. source data in maternity study

    Started by CTM_NBT, 21st Apr 2015 01:01 PM
    • Replies: 0
    • Views: 8,998
    21st Apr 2015, 01:01 PM Go to last post
  8. Source Data and CRFs

    Started by sugarg, 28th Nov 2011 11:18 AM
    • Replies: 5
    • Views: 27,556
    2nd Feb 2012, 05:10 PM Go to last post
  9. SIV documents_SIV attendance log and training log

    Started by elena123, 2nd Dec 2016 12:11 PM
    • Replies: 0
    • Views: 4,818
    2nd Dec 2016, 12:11 PM Go to last post
  10. Wink Site Signature and Delegation Logs

    Started by qalassinoz, 29th Mar 2012 07:17 AM
    2 Pages
    1 2
    • Replies: 11
    • Views: 40,474
    11th Jan 2016, 02:27 PM Go to last post
    • Replies: 1
    • Views: 1,324
    10th Dec 2018, 04:20 PM Go to last post
    • Replies: 3
    • Views: 13,683
    7th May 2016, 08:36 AM Go to last post
  11. SDL Delegated Tasks for Research Nurses

    Started by Leigh, 21st Jul 2016 04:08 PM
    • Replies: 0
    • Views: 5,584
    21st Jul 2016, 04:08 PM Go to last post
  12. SDL Delegated Tasks for Research Nurses

    Started by Leigh, 21st Jul 2016 04:14 PM
    • Replies: 2
    • Views: 12,278
    3rd Aug 2016, 12:30 PM Go to last post
  13. Scanned Source Documents

    Started by Jasper, 12th Jan 2012 10:37 PM
    • Replies: 2
    • Views: 6,665
    22nd Jun 2012, 05:45 PM Go to last post
    • Replies: 2
    • Views: 12,202
    22nd Mar 2016, 05:13 PM Go to last post
  14. Retrospective Consent for additional samples?

    Started by MsJones, 26th May 2016 10:45 AM
    • Replies: 2
    • Views: 16,147
    1st Jun 2016, 02:33 PM Go to last post
  15. Responsibility of PI when Study Archived

    Started by kate lees, 26th Jun 2014 08:00 AM
    • Replies: 1
    • Views: 8,997
    27th Jun 2014, 10:41 AM Go to last post
  16. Reporting of Race and Ethnicity

    Started by David, 15th Feb 2012 04:09 PM
    • Replies: 1
    • Views: 6,852
    1st Sep 2012, 11:25 AM Go to last post
  17. Reimbursement for patients time

    Started by klapsa, 27th Feb 2014 02:49 PM
    • Replies: 1
    • Views: 8,323
    27th Feb 2014, 05:37 PM Go to last post
    • Replies: 0
    • Views: 6,033
    5th Nov 2016, 12:01 PM Go to last post
  18. Reconsenting due to change of PI

    Started by DataAndQualityManager, 14th Apr 2016 07:50 PM
    • Replies: 3
    • Views: 10,963
    22nd Apr 2016, 08:11 AM Go to last post
  19. Pregnancy testing not included in the protocol

    Started by lilo1929, 30th Mar 2015 03:41 PM
    • Replies: 0
    • Views: 8,690
    30th Mar 2015, 03:41 PM Go to last post
  20. PI Responsibilities & Long term sick leave

    Started by Cameron Glen, 12th Aug 2014 08:55 AM
    • Replies: 3
    • Views: 11,678
    21st Sep 2014, 08:54 PM Go to last post
  21. PI delegating PI duties?

    Started by MonitorH, 10th May 2013 10:27 AM
    • Replies: 5
    • Views: 26,351
    25th Sep 2014, 05:33 PM Go to last post
    • Replies: 1
    • Views: 5,967
    19th Jan 2012, 11:55 AM Go to last post
  22. Patient consented but not randomized - paperwork

    Started by DJH, 22nd Sep 2016 01:41 PM
    • Replies: 1
    • Views: 8,661
    23rd Sep 2016, 07:24 AM Go to last post
  23. Patient Confidentiality and Data Protection

    Started by E.Atkin, 8th May 2013 11:04 AM
    • Replies: 1
    • Views: 8,864
    10th May 2013, 10:13 AM Go to last post
  24. Nurse Clinician Causilty assesment

    Started by SW220517, 27th Sep 2017 06:58 PM
    • Replies: 0
    • Views: 2,599
    27th Sep 2017, 06:58 PM Go to last post

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