Good Clinical Practice Guide
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Forum: Trial Master File (TMF) and archiving

  1. Sticky Thread Sticky: MHRA produced FAQs for Trial Master Files (TMF) and Archiving

    Started by MHRA Super Moderator, 17th Dec 2012 03:11 PM
    2 Pages
    1 2
    • Replies: 17
    • Views: 570,097
    17th Dec 2012, 03:43 PM Go to last post
  2. Sticky Thread Sticky: Retention of Trial Records

    Started by MHRA Super Moderator, 25th Nov 2015 01:50 PM
    • Replies: 0
    • Views: 286,797
    25th Nov 2015, 01:50 PM Go to last post
  1. Site staff CVs in TMF?

    Started by KCH, 20th Nov 2017 05:46 PM
    • Replies: 1
    • Views: 158,991
    1st Oct 2019, 08:21 PM Go to last post
  2. Mixing ink and digital signatures

    Started by Heather, 11th Aug 2015 02:33 PM
    • Replies: 1
    • Views: 149,424
    27th Nov 2015, 11:44 AM Go to last post
  3. Screening Log & Identifiable information

    Started by samyangnudle, 5th Apr 2019 04:19 PM
    • Replies: 1
    • Views: 133,292
    16th Apr 2019, 03:36 PM Go to last post
  4. Electronic archiving of ISFs and E-CRFs

    Started by Fachelray, 6th Mar 2019 12:11 PM
    • Replies: 1
    • Views: 112,200
    7th Mar 2019, 10:15 AM Go to last post
  5. Subject ID Log

    Started by ztarfizh, 2nd Jul 2015 07:06 PM
    • Replies: 1
    • Views: 104,106
    9th Jul 2015, 02:50 PM Go to last post
  6. Does the MHRA hate file notes?

    Started by Trial Manager, 5th Sep 2016 03:25 PM
    • Replies: 4
    • Views: 87,638
    28th Sep 2016, 12:50 AM Go to last post
    • Replies: 4
    • Views: 79,060
    6th Sep 2018, 07:34 PM Go to last post
  7. MHRA blog on the trial master file (TMF)

    Started by MHRA, 30th Jul 2015 05:10 PM
    • Replies: 0
    • Views: 78,121
    30th Jul 2015, 05:10 PM Go to last post
  8. Collection of Lab Director's CVs for Local Labs

    Started by S1smith, 30th Oct 2020 03:13 PM
    • Replies: 0
    • Views: 77,433
    30th Oct 2020, 03:13 PM Go to last post
  9. TMF Index

    Started by AP78, 30th Aug 2012 08:56 AM
    • Replies: 2
    • Views: 73,799
    31st Aug 2012, 12:09 PM Go to last post
  10. Redacting patient identifiers for research archiving

    Started by BasseyK, 12th Jun 2019 08:33 AM
    • Replies: 1
    • Views: 72,352
    14th Jun 2019, 07:42 PM Go to last post
  11. Transfer of sponsor

    Started by Linda Scully, 22nd Nov 2017 01:18 PM
    • Replies: 2
    • Views: 66,717
    24th Nov 2017, 12:27 PM Go to last post
  12. Paper TMF - wet ink Protocol Signatures

    Started by PHW, 20th Feb 2018 02:51 PM
    • Replies: 2
    • Views: 65,405
    1st Mar 2018, 10:57 AM Go to last post
  13. Trial Master File in SharePoint

    Started by DG01, 23rd Nov 2011 10:39 AM
    • Replies: 4
    • Views: 64,778
    8th Mar 2012, 01:42 AM Go to last post
  14. CRF retention at the end of trial

    Started by Development QA, 28th Jun 2018 10:51 AM
    • Replies: 2
    • Views: 61,983
    17th Jul 2018, 11:22 AM Go to last post
  15. Use of colour to decipher correspondence

    Started by Fachelray, 16th Jul 2019 12:35 PM
    • Replies: 2
    • Views: 57,825
    15th Sep 2019, 11:10 AM Go to last post
  16. Emails from Study email account to eTMF

    Started by peglleduc, 17th Feb 2012 01:46 PM
    • Replies: 2
    • Views: 55,075
    15th Oct 2014, 06:09 PM Go to last post
  17. Keeping Originals / wet-ink with eTMF.

    Started by sashraf, 26th Jul 2017 02:27 PM
    • Replies: 1
    • Views: 54,805
    27th Jul 2017, 11:07 AM Go to last post
  18. End of Study Definition for Archiving

    Started by ztarfizh, 24th Jul 2012 10:08 AM
    • Replies: 3
    • Views: 52,598
    10th Sep 2016, 10:26 AM Go to last post
  19. Essential Documents and Non-Selected Sites

    Started by souderb, 30th May 2018 03:11 PM
    • Replies: 0
    • Views: 51,791
    30th May 2018, 03:11 PM Go to last post
  20. Database and TMF

    Started by markepoulton, 23rd Jul 2015 01:34 PM
    • Replies: 1
    • Views: 49,960
    27th Jul 2015, 10:46 AM Go to last post
  21. Minimum retention period for the sponsor

    Started by rammellconsult, 1st Nov 2011 02:46 PM
    • Replies: 4
    • Views: 43,828
    4th Nov 2011, 10:24 AM Go to last post
  22. using sponsor SOP for TMF

    Started by cansel, 21st Apr 2012 07:58 AM
    • Replies: 0
    • Views: 42,872
    21st Apr 2012, 07:58 AM Go to last post
  23. Patient medical notes and source data

    Started by Jasper, 27th Nov 2012 08:33 AM
    • Replies: 1
    • Views: 42,402
    27th Nov 2012, 12:34 PM Go to last post
    • Replies: 1
    • Views: 42,163
    5th Mar 2014, 12:12 PM Go to last post
  24. Electronic and Digital signatures

    Started by PHW, 11th Jun 2018 10:59 AM
    • Replies: 0
    • Views: 41,533
    11th Jun 2018, 10:59 AM Go to last post
  25. Physical Record Storage/Archival

    Started by scott.mcculloch, 16th Feb 2015 11:02 AM
    • Replies: 0
    • Views: 41,455
    16th Feb 2015, 11:02 AM Go to last post
    • Replies: 1
    • Views: 40,738
    8th Aug 2016, 12:41 AM Go to last post
  26. Amendment 60 to 2001/20/E

    Started by Karen Goode, 19th Apr 2013 12:02 PM
    • Replies: 1
    • Views: 40,007
    20th Apr 2013, 02:28 PM Go to last post
  27. Physical Archiving Conditions

    Started by RS14, 14th Apr 2014 04:27 PM
    • Replies: 1
    • Views: 38,182
    30th Apr 2014, 05:18 PM Go to last post

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