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: 119,140
    MHRA Super Moderator
    2nd May 2013, 03:34 PM Go to last post

  1. Phase I accreditation - physician resuscitation experience

    Started by ztarfizh, 30th Dec 2011 10:00 PM
    • Replies: 1
    • Views: 11,520
    MHRA Moderator
    19th Jan 2012, 11:55 AM Go to last post

  2. Fasting before Consent

    Started by ztarfizh, 26th Nov 2012 11:11 AM
    • Replies: 2
    • Views: 52,672
    a123456
    27th Nov 2012, 03:58 PM Go to last post

  3. Documenting SAE causality in source data

    Started by ztarfizh, 7th Apr 2014 03:23 PM
    • Replies: 4
    • Views: 41,978
    MHRA Moderator
    6th Aug 2015, 09:51 AM Go to last post

  4. Duration of informed consent after death

    Started by ztarfizh, 31st Jan 2020 01:29 PM
    • Replies: 2
    • Views: 8,727
    a123456
    18th Feb 2020, 08:08 PM Go to last post

  5. Filing in patient notes

    Started by wigs, 9th Feb 2017 04:18 PM
    • Replies: 3
    • Views: 47,498
    a123456
    12th Aug 2021, 10:26 AM Go to last post

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

    Started by TrialsAdvice, 16th Feb 2021 07:06 PM
    • Replies: 2
    • Views: 29,603
    a123456
    6th Jun 2021, 03:06 PM Go to last post

  7. Subjects date of consent

    Started by Trialblazer, 7th Aug 2017 02:25 PM
    • Replies: 1
    • Views: 35,283
    a123456
    15th Sep 2017, 07:46 PM Go to last post

  8. Sending copies of anonymised consent forms to sponsor

    Started by Trial Manager, 25th Apr 2016 11:23 AM
    • Replies: 3
    • Views: 46,157
    a123456
    7th May 2016, 08:36 AM Go to last post

  9. Nurse Clinician Causilty assesment

    Started by SW220517, 27th Sep 2017 06:58 PM
    • Replies: 0
    • Views: 30,580
    SW220517
    27th Sep 2017, 06:58 PM Go to last post

  10. Source Data and CRFs

    Started by sugarg, 28th Nov 2011 11:18 AM
    • Replies: 5
    • Views: 111,902
    sugarg
    2nd Feb 2012, 05:10 PM Go to last post

  11. ‘Re-consenting’ trial participants

    Started by SRH, 24th May 2012 11:24 AM
    • Replies: 3
    • Views: 144,941
    a123456
    23rd Dec 2017, 11:20 AM Go to last post

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

    Started by SRH, 25th Feb 2015 04:19 PM
    • Replies: 0
    • Views: 64,147
    SRH
    25th Feb 2015, 04:19 PM Go to last post

  13. Investigator CVs and GCP training

    Started by Speediepup, 2nd Jan 2014 03:35 PM
    • Replies: 1
    • Views: 171,682
    a123456
    4th Jan 2014, 12:46 PM Go to last post

  14. Sub/Co-Investigator absence and delegation of authority

    Started by smezzian, 19th Jul 2021 06:25 PM
    • Replies: 1
    • Views: 15,032
    a123456
    5th Aug 2021, 03:08 PM Go to last post

  15. Delegation log- CVs and GCP certificates

    Started by sab14, 16th Oct 2020 04:11 PM
    • Replies: 1
    • Views: 15,419
    a123456
    18th Jan 2021, 04:22 PM Go to last post

  16. Informed Consent Forms stored in ISF

    Started by S Townsend, 20th May 2014 10:48 AM
    • Replies: 3
    • Views: 22,920
    a123456
    4th Jun 2014, 06:21 AM Go to last post

  17. PI oversight of trials with central pharmacy

    Started by RFay, 24th Aug 2023 02:53 PM
    • Replies: 1
    • Views: 5,540
    a123456
    29th Aug 2023, 04:19 PM Go to last post

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

    Started by ResearchMW, 5th Nov 2016 12:01 PM
    • Replies: 1
    • Views: 44,032
    Sophie1
    18th May 2021, 05:04 PM Go to last post

  19. Volunteers attending screening but not consenting

    Started by Research Coordinator, 7th Jun 2013 04:01 PM
    • Replies: 1
    • Views: 16,877
    a123456
    11th Jun 2013, 04:30 PM Go to last post

  20. Adverse event before dosing

    Started by quality234, 29th Jun 2020 08:28 AM
    • Replies: 1
    • Views: 16,792
    a123456
    28th Sep 2020, 07:35 PM Go to last post

  21. Wink Site Signature and Delegation Logs

    Started by qalassinoz, 29th Mar 2012 07:17 AM
    2 Pages •
    1 2
    • Replies: 13
    • Views: 277,752
    a123456
    16th Feb 2023, 05:24 PM Go to last post

  22. Missing Medical Notes

    Started by Praseeda12, 16th Dec 2015 03:15 PM
    • Replies: 1
    • Views: 53,112
    a123456
    17th Dec 2015, 06:00 PM Go to last post

  23. Filing signed informed consent forms in site file

    Started by plamb, 24th Aug 2012 04:26 PM
    • Replies: 5
    • Views: 60,600
    G&T
    4th Jan 2013, 02:49 PM Go to last post

  24. GCP certiifcates for local lab staff

    Started by plamb, 10th Jan 2014 01:11 PM
    • Replies: 2
    • Views: 14,554
    plamb
    13th Feb 2014, 12:24 PM Go to last post

  25. ECG tracings

    Started by plamb, 15th May 2015 04:47 PM
    • Replies: 1
    • Views: 38,934
    plamb
    21st Oct 2015, 11:33 AM Go to last post

  26. 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: 37,591
    a123456
    10th Dec 2018, 04:20 PM Go to last post

  27. SUSARs sent to pharmacies

    Started by Nikki Dewick, 23rd Oct 2015 12:43 PM
    • Replies: 0
    • Views: 75,323
    Nikki Dewick
    23rd Oct 2015, 12:43 PM Go to last post

  28. Completing a 1572

    Started by nick dance, 7th Feb 2019 03:32 PM
    • Replies: 1
    • Views: 142,357
    a123456
    8th Feb 2019, 10:25 AM Go to last post

  29. Submission of PI for FIH studies application

    Started by Natasha, 29th Jul 2015 10:06 AM
    • Replies: 1
    • Views: 44,037
    MHRA Moderator
    29th Jul 2015, 12:09 PM Go to last post

  30. Redacted source documents

    Started by NAdey, 23rd Oct 2019 10:05 AM
    • Replies: 1
    • Views: 50,179
    a123456
    24th Oct 2019, 08:06 PM Go to last post
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