Good Clinical Practice Guide
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Threads 31 to 60 of 80

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: 121,759
    MHRA Super Moderator
    2nd May 2013, 03:34 PM Go to last post

  1. Same person acting as both sponsor AND site staff - inappropriate?

    Started by TrialsAdvice, 16th Feb 2021 07:06 PM
    • Replies: 2
    • Views: 30,225
    a123456
    6th Jun 2021, 03:06 PM Go to last post

  2. Translator signing ICF as a witness

    Started by MonitorH, 3rd Sep 2012 01:17 PM
    • Replies: 1
    • Views: 30,277
    a123456
    4th Sep 2012, 09:34 AM Go to last post

  3. Nurse Clinician Causilty assesment

    Started by SW220517, 27th Sep 2017 06:58 PM
    • Replies: 0
    • Views: 31,634
    SW220517
    27th Sep 2017, 06:58 PM Go to last post

  4. SDL Delegated Tasks for Research Nurses

    Started by Leigh, 21st Jul 2016 04:08 PM
    • Replies: 0
    • Views: 31,738
    Leigh
    21st Jul 2016, 04:08 PM Go to last post

  5. Source data queries

    Started by ecsy911, 15th Apr 2015 12:07 PM
    • Replies: 2
    • Views: 32,141
    ecsy911
    28th Apr 2015, 09:08 AM Go to last post

  6. Informed consent and safety update

    Started by Kaunas201, 8th Oct 2012 06:53 PM
    • Replies: 0
    • Views: 32,571
    Kaunas201
    8th Oct 2012, 06:53 PM Go to last post

  7. Subjects date of consent

    Started by Trialblazer, 7th Aug 2017 02:25 PM
    • Replies: 1
    • Views: 36,485
    a123456
    15th Sep 2017, 07:46 PM Go to last post

  8. Destruction of Paper Patient Notes

    Started by kate lees, 26th Jun 2014 08:02 AM
    • Replies: 5
    • Views: 38,543
    MHRA Super Moderator
    25th Feb 2015, 12:15 PM Go to last post

  9. Should people carrying out their normal clinical role be added to Delegation Log

    Started by Patricia, 18th Oct 2018 02:48 PM
    • Replies: 1
    • Views: 38,592
    a123456
    10th Dec 2018, 04:20 PM Go to last post

  10. Delegation of electronic training by PI

    Started by ArthurD, 29th Oct 2017 11:12 AM
    • Replies: 0
    • Views: 38,705
    ArthurD
    29th Oct 2017, 11:12 AM Go to last post

  11. SDL Delegated Tasks for Research Nurses

    Started by Leigh, 21st Jul 2016 04:14 PM
    • Replies: 2
    • Views: 39,340
    a123456
    3rd Aug 2016, 12:30 PM Go to last post

  12. ECG tracings

    Started by plamb, 15th May 2015 04:47 PM
    • Replies: 1
    • Views: 39,614
    plamb
    21st Oct 2015, 11:33 AM Go to last post

  13. Question Return of consent forms by post (CTIMP in rare disease area)

    Started by CGW1981, 11th Mar 2016 11:18 AM
    • Replies: 2
    • Views: 39,722
    CGW1981
    22nd Mar 2016, 05:13 PM Go to last post

  14. Documenting SAE causality in source data

    Started by ztarfizh, 7th Apr 2014 03:23 PM
    • Replies: 4
    • Views: 42,637
    MHRA Moderator
    6th Aug 2015, 09:51 AM Go to last post

  15. Submission of PI for FIH studies application

    Started by Natasha, 29th Jul 2015 10:06 AM
    • Replies: 1
    • Views: 44,581
    MHRA Moderator
    29th Jul 2015, 12:09 PM Go to last post

  16. Recording of consent - what should be written in patient notes?

    Started by ResearchMW, 5th Nov 2016 12:01 PM
    • Replies: 1
    • Views: 45,084
    Sophie1
    18th May 2021, 05:04 PM Go to last post

  17. Patient consented but not randomized - paperwork

    Started by DJH, 22nd Sep 2016 01:41 PM
    • Replies: 3
    • Views: 46,130
    a123456
    6th Mar 2020, 09:58 PM Go to last post

  18. Sending copies of anonymised consent forms to sponsor

    Started by Trial Manager, 25th Apr 2016 11:23 AM
    • Replies: 3
    • Views: 47,299
    a123456
    7th May 2016, 08:36 AM Go to last post

  19. PI has left, no new PI available yet.

    Started by M240484, 1st Feb 2019 07:17 AM
    • Replies: 1
    • Views: 48,044
    a123456
    5th Feb 2019, 07:37 PM Go to last post

  20. Filing in patient notes

    Started by wigs, 9th Feb 2017 04:18 PM
    • Replies: 3
    • Views: 48,865
    a123456
    12th Aug 2021, 10:26 AM Go to last post

  21. Question Independent Nurse Prescribers in Clinical Trials

    Started by Jasper, 17th Jul 2013 09:43 PM
    • Replies: 1
    • Views: 50,125
    a123456
    19th Jul 2013, 08:00 PM Go to last post

  22. Electronic Source Data Access for Monitors and Inspectors

    Started by Mikayala, 9th Oct 2018 10:04 AM
    • Replies: 8
    • Views: 50,990
    a123456
    7th Feb 2021, 07:48 PM Go to last post

  23. Redacted source documents

    Started by NAdey, 23rd Oct 2019 10:05 AM
    • Replies: 1
    • Views: 51,438
    a123456
    24th Oct 2019, 08:06 PM Go to last post

  24. Fasting before Consent

    Started by ztarfizh, 26th Nov 2012 11:11 AM
    • Replies: 2
    • Views: 53,327
    a123456
    27th Nov 2012, 03:58 PM Go to last post

  25. Missing Medical Notes

    Started by Praseeda12, 16th Dec 2015 03:15 PM
    • Replies: 1
    • Views: 54,020
    a123456
    17th Dec 2015, 06:00 PM Go to last post

  26. SIV documents_SIV attendance log and training log

    Started by elena123, 2nd Dec 2016 12:11 PM
    • Replies: 0
    • Views: 56,004
    elena123
    2nd Dec 2016, 12:11 PM Go to last post

  27. Retrospective Consent for additional samples?

    Started by MsJones, 26th May 2016 10:45 AM
    • Replies: 2
    • Views: 56,546
    MsJones
    1st Jun 2016, 02:33 PM Go to last post

  28. Conflict of interest

    Started by debbie.spruce, 13th Feb 2019 11:12 AM
    • Replies: 2
    • Views: 57,752
    debbie.spruce
    18th Feb 2019, 12:14 PM Go to last post

  29. Filing signed informed consent forms in site file

    Started by plamb, 24th Aug 2012 04:26 PM
    • Replies: 5
    • Views: 61,242
    G&T
    4th Jan 2013, 02:49 PM Go to last post

  30. Exclusion criterion - participation in previous clinical trial within three months

    Started by SRH, 25th Feb 2015 04:19 PM
    • Replies: 0
    • Views: 65,236
    SRH
    25th Feb 2015, 04:19 PM Go to last post
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