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: 109,178
    2nd May 2013, 03:34 PM Go to last post
  1. Physician Associates and Nurse Practitioners

    Started by Amanda Hensby, 28th Jun 2022 11:29 AM
    • Replies: 0
    • Views: 5,022
    28th Jun 2022, 11:29 AM Go to last post
  2. PI oversight of trials with central pharmacy

    Started by RFay, 24th Aug 2023 02:53 PM
    • Replies: 1
    • Views: 5,381
    29th Aug 2023, 04:19 PM Go to last post
    • Replies: 0
    • Views: 5,842
    18th Jun 2012, 11:26 AM Go to last post
  3. Image files as Source Data

    Started by ltebbs, 10th Nov 2011 05:36 PM
    • Replies: 1
    • Views: 5,886
    14th Nov 2011, 05:16 PM Go to last post
  4. "Dictated" source data

    Started by LucCo, 22nd Jun 2012 08:20 AM
    • Replies: 1
    • Views: 6,922
    22nd Jun 2012, 03:58 PM Go to last post
  5. Consent for possible future uses of data

    Started by Catherine, 4th Nov 2011 11:35 AM
    • Replies: 2
    • Views: 7,665
    17th Nov 2011, 06:08 PM Go to last post
  6. Duration of informed consent after death

    Started by ztarfizh, 31st Jan 2020 01:29 PM
    • Replies: 2
    • Views: 8,215
    18th Feb 2020, 08:08 PM Go to last post
    • Replies: 0
    • Views: 9,574
    8th Mar 2023, 02:54 PM Go to last post
  7. Scanned Source Documents

    Started by Jasper, 12th Jan 2012 10:37 PM
    • Replies: 2
    • Views: 11,107
    22nd Jun 2012, 05:45 PM Go to last post
    • Replies: 1
    • Views: 11,418
    19th Jan 2012, 11:55 AM Go to last post
  8. Reporting of Race and Ethnicity

    Started by David, 15th Feb 2012 04:09 PM
    • Replies: 1
    • Views: 11,578
    1st Sep 2012, 11:25 AM Go to last post
  9. Pregnancy testing not included in the protocol

    Started by lilo1929, 30th Mar 2015 03:41 PM
    • Replies: 0
    • Views: 11,630
    30th Mar 2015, 03:41 PM Go to last post
  10. Personally dating documents?

    Started by Kar3n, 23rd Mar 2022 01:18 PM
    • Replies: 2
    • Views: 11,677
    26th Mar 2022, 08:34 PM Go to last post
  11. Question Data Archival Requirements

    Started by castede1, 7th Jan 2015 07:25 PM
    • Replies: 0
    • Views: 11,691
    7th Jan 2015, 07:25 PM Go to last post
    • Replies: 1
    • Views: 12,240
    31st Jul 2022, 06:18 PM Go to last post
  12. Reimbursement for patients time

    Started by klapsa, 27th Feb 2014 02:49 PM
    • Replies: 1
    • Views: 12,592
    27th Feb 2014, 05:37 PM Go to last post
  13. GCP certiifcates for local lab staff

    Started by plamb, 10th Jan 2014 01:11 PM
    • Replies: 2
    • Views: 14,356
    13th Feb 2014, 12:24 PM Go to last post
    • Replies: 1
    • Views: 14,542
    5th Aug 2021, 03:08 PM Go to last post
  14. Delegation log- CVs and GCP certificates

    Started by sab14, 16th Oct 2020 04:11 PM
    • Replies: 1
    • Views: 14,819
    18th Jan 2021, 04:22 PM Go to last post
  15. Patient Confidentiality and Data Protection

    Started by E.Atkin, 8th May 2013 11:04 AM
    • Replies: 1
    • Views: 15,581
    10th May 2013, 10:13 AM Go to last post
  16. Adverse event before dosing

    Started by quality234, 29th Jun 2020 08:28 AM
    • Replies: 1
    • Views: 16,226
    28th Sep 2020, 07:35 PM Go to last post
    • Replies: 1
    • Views: 16,721
    11th Jun 2013, 04:30 PM Go to last post
  17. Responsibility of PI when Study Archived

    Started by kate lees, 26th Jun 2014 08:00 AM
    • Replies: 1
    • Views: 17,126
    27th Jun 2014, 10:41 AM Go to last post
  18. Electronic consent

    Started by h.williams, 23rd Apr 2012 09:43 AM
    • Replies: 1
    • Views: 17,739
    10th Feb 2015, 05:25 PM Go to last post
  19. Restriction on number of screening attempts?

    Started by Kar3n, 17th Feb 2020 10:33 AM
    • Replies: 3
    • Views: 18,066
    24th Feb 2020, 10:38 AM Go to last post
  20. Delegation log in Pharmacy file

    Started by ilyas ali, 1st Mar 2012 10:41 PM
    • Replies: 4
    • Views: 19,330
    24th Apr 2013, 04:48 PM Go to last post
  21. source data in maternity study

    Started by CTM_NBT, 21st Apr 2015 01:01 PM
    • Replies: 0
    • Views: 22,343
    21st Apr 2015, 01:01 PM Go to last post
  22. Informed Consent Forms stored in ISF

    Started by S Townsend, 20th May 2014 10:48 AM
    • Replies: 3
    • Views: 22,493
    4th Jun 2014, 06:21 AM Go to last post
  23. Translator signing ICF as a witness

    Started by MonitorH, 3rd Sep 2012 01:17 PM
    • Replies: 1
    • Views: 25,008
    4th Sep 2012, 09:34 AM Go to last post
  24. Electronic Patient Records

    Started by Jasper, 14th Mar 2012 08:48 PM
    • Replies: 4
    • Views: 25,114
    13th Feb 2015, 09:59 PM Go to last post

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