Good Clinical Practice Guide
Page 1 of 3 123 LastLast
Threads 1 to 30 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: 117,033
    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: 11,474
    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: 51,988
    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: 41,751
    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: 8,479
    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: 47,030
    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: 29,422
    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: 34,901
    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: 45,813
    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: 30,249
    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: 110,711
    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: 143,310
    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: 63,835
    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: 168,461
    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: 14,878
    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: 15,226
    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: 22,840
    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: 5,503
    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: 43,707
    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: 16,827
    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: 16,542
    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: 273,604
    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: 52,838
    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: 59,948
    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: 14,496
    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: 38,720
    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: 37,245
    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: 74,985
    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: 139,133
    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: 43,879
    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: 49,412
    a123456
    24th Oct 2019, 08:06 PM Go to last post
Page 1 of 3 123 LastLast

Forum information and options

Moderators of this Forum

Thread Display Options

Use this control to limit the display of threads to those newer than the specified time frame.

Allows you to choose the data by which the thread list will be sorted.

Order threads in...

Note: when sorting by date, 'descending order' will show the newest results first.

Icon legend

Contains unread posts
Contains unread posts
Contains no unread posts
Contains no unread posts
More than 15 replies or 150 views
Hot thread with unread posts
More than 15 replies or 150 views
Hot thread with no unread posts
Closed Thread
Thread is closed
Thread Contains a Message Written By You
You have posted in this thread

Posting Permissions

  • You may not post new threads
  • You may not post replies
  • You may not post attachments
  • You may not edit your posts
  •  

Forum Rules