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: 23,689
    2nd May 2013, 03:34 PM Go to last post
    • Replies: 1
    • Views: 6,048
    19th Jan 2012, 11:55 AM Go to last post
  1. Fasting before Consent

    Started by ztarfizh, 26th Nov 2012 11:11 AM
    • Replies: 2
    • Views: 7,589
    27th Nov 2012, 03:58 PM Go to last post
  2. Documenting SAE causality in source data

    Started by ztarfizh, 7th Apr 2014 03:23 PM
    • Replies: 4
    • Views: 15,762
    6th Aug 2015, 09:51 AM Go to last post
  3. Filing in patient notes

    Started by wigs, 9th Feb 2017 04:18 PM
    • Replies: 2
    • Views: 8,328
    22nd Feb 2017, 02:49 PM Go to last post
  4. Subjects date of consent

    Started by Trialblazer, 7th Aug 2017 02:25 PM
    • Replies: 1
    • Views: 4,401
    15th Sep 2017, 07:46 PM Go to last post
    • Replies: 3
    • Views: 13,854
    7th May 2016, 08:36 AM Go to last post
  5. Nurse Clinician Causilty assesment

    Started by SW220517, 27th Sep 2017 06:58 PM
    • Replies: 0
    • Views: 2,703
    27th Sep 2017, 06:58 PM Go to last post
  6. Source Data and CRFs

    Started by sugarg, 28th Nov 2011 11:18 AM
    • Replies: 5
    • Views: 28,149
    2nd Feb 2012, 05:10 PM Go to last post
  7. ‘Re-consenting’ trial participants

    Started by SRH, 24th May 2012 11:24 AM
    • Replies: 3
    • Views: 19,008
    23rd Dec 2017, 11:20 AM Go to last post
    • Replies: 0
    • Views: 22,398
    25th Feb 2015, 04:19 PM Go to last post
  8. Investigator CVs and GCP training

    Started by Speediepup, 2nd Jan 2014 03:35 PM
    • Replies: 1
    • Views: 20,393
    4th Jan 2014, 12:46 PM Go to last post
  9. Informed Consent Forms stored in ISF

    Started by S Townsend, 20th May 2014 10:48 AM
    • Replies: 3
    • Views: 10,317
    4th Jun 2014, 06:21 AM Go to last post
    • Replies: 0
    • Views: 6,139
    5th Nov 2016, 12:01 PM Go to last post
    • Replies: 1
    • Views: 10,832
    11th Jun 2013, 04:30 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: 41,076
    11th Jan 2016, 02:27 PM Go to last post
  11. Missing Medical Notes

    Started by Praseeda12, 16th Dec 2015 03:15 PM
    • Replies: 1
    • Views: 22,161
    17th Dec 2015, 06:00 PM Go to last post
  12. Filing signed informed consent forms in site file

    Started by plamb, 24th Aug 2012 04:26 PM
    • Replies: 5
    • Views: 20,495
    4th Jan 2013, 02:49 PM Go to last post
  13. GCP certiifcates for local lab staff

    Started by plamb, 10th Jan 2014 01:11 PM
    • Replies: 2
    • Views: 9,627
    13th Feb 2014, 12:24 PM Go to last post
  14. ECG tracings

    Started by plamb, 15th May 2015 04:47 PM
    • Replies: 1
    • Views: 10,186
    21st Oct 2015, 11:33 AM Go to last post
    • Replies: 1
    • Views: 1,452
    10th Dec 2018, 04:20 PM Go to last post
  15. SUSARs sent to pharmacies

    Started by Nikki Dewick, 23rd Oct 2015 12:43 PM
    • Replies: 0
    • Views: 23,983
    23rd Oct 2015, 12:43 PM Go to last post
  16. Completing a 1572

    Started by nick dance, 7th Feb 2019 03:32 PM
    • Replies: 1
    • Views: 1,678
    8th Feb 2019, 10:25 AM Go to last post
  17. Submission of PI for FIH studies application

    Started by Natasha, 29th Jul 2015 10:06 AM
    • Replies: 1
    • Views: 10,144
    29th Jul 2015, 12:09 PM Go to last post
  18. Retrospective Consent for additional samples?

    Started by MsJones, 26th May 2016 10:45 AM
    • Replies: 2
    • Views: 16,298
    1st Jun 2016, 02:33 PM Go to last post
  19. Translator signing ICF as a witness

    Started by MonitorH, 3rd Sep 2012 01:17 PM
    • Replies: 1
    • Views: 5,786
    4th Sep 2012, 09:34 AM Go to last post
  20. PI delegating PI duties?

    Started by MonitorH, 10th May 2013 10:27 AM
    • Replies: 5
    • Views: 26,644
    25th Sep 2014, 05:33 PM Go to last post
    • Replies: 6
    • Views: 3,608
    21st Nov 2018, 04:19 PM Go to last post
  21. "Dictated" source data

    Started by LucCo, 22nd Jun 2012 08:20 AM
    • Replies: 1
    • Views: 3,686
    22nd Jun 2012, 03:58 PM Go to last post
  22. Image files as Source Data

    Started by ltebbs, 10th Nov 2011 05:36 PM
    • Replies: 1
    • Views: 3,281
    14th Nov 2011, 05:16 PM Go to last post
  23. Pregnancy testing not included in the protocol

    Started by lilo1929, 30th Mar 2015 03:41 PM
    • Replies: 0
    • Views: 8,734
    30th Mar 2015, 03:41 PM Go to last post

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