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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: 116,361
    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: 33,067
    25th Nov 2015, 01:50 PM Go to last post
  1. Minimum retention period for the sponsor

    Started by rammellconsult, 1st Nov 2011 02:46 PM
    • Replies: 4
    • Views: 29,144
    4th Nov 2011, 10:24 AM Go to last post
  2. Mixing ink and digital signatures

    Started by Heather, 11th Aug 2015 02:33 PM
    • Replies: 1
    • Views: 24,696
    27th Nov 2015, 11:44 AM Go to last post
  3. Does the MHRA hate file notes?

    Started by Trial Manager, 5th Sep 2016 03:25 PM
    • Replies: 4
    • Views: 21,403
    28th Sep 2016, 12:50 AM Go to last post
  4. Trial Master File in SharePoint

    Started by DG01, 23rd Nov 2011 10:39 AM
    • Replies: 4
    • Views: 18,285
    8th Mar 2012, 01:42 AM Go to last post
    • Replies: 4
    • Views: 17,466
    6th Sep 2018, 07:34 PM Go to last post
  5. End of Study Definition for Archiving

    Started by ztarfizh, 24th Jul 2012 10:08 AM
    • Replies: 3
    • Views: 16,977
    10th Sep 2016, 10:26 AM Go to last post
  6. Patient medical notes and source data

    Started by Jasper, 27th Nov 2012 08:33 AM
    • Replies: 1
    • Views: 16,198
    27th Nov 2012, 12:34 PM Go to last post
  7. TMF Index

    Started by AP78, 30th Aug 2012 08:56 AM
    • Replies: 2
    • Views: 14,650
    31st Aug 2012, 12:09 PM Go to last post
  8. Emails from Study email account to eTMF

    Started by peglleduc, 17th Feb 2012 01:46 PM
    • Replies: 2
    • Views: 14,354
    15th Oct 2014, 06:09 PM Go to last post
  9. Requirements electronic archive

    Started by DG01, 22nd Nov 2011 01:47 PM
    • Replies: 1
    • Views: 13,779
    23rd Nov 2011, 12:08 PM Go to last post
  10. Talking Shadow TMF requirements

    Started by cahill23, 16th Nov 2011 05:02 PM
    • Replies: 1
    • Views: 13,236
    17th Nov 2011, 09:26 AM Go to last post
  11. Database and TMF

    Started by markepoulton, 23rd Jul 2015 01:34 PM
    • Replies: 1
    • Views: 13,156
    27th Jul 2015, 10:46 AM Go to last post
  12. using sponsor SOP for TMF

    Started by cansel, 21st Apr 2012 07:58 AM
    • Replies: 0
    • Views: 12,883
    21st Apr 2012, 07:58 AM Go to last post
  13. Archiving of training records

    Started by SAMMY, 19th Jan 2012 03:15 PM
    • Replies: 2
    • Views: 12,782
    20th Jan 2012, 12:37 PM Go to last post
  14. MHRA blog on the trial master file (TMF)

    Started by MHRA, 30th Jul 2015 05:10 PM
    • Replies: 0
    • Views: 12,400
    30th Jul 2015, 05:10 PM Go to last post
  15. Amendment 60 to 2001/20/E

    Started by Karen Goode, 19th Apr 2013 12:02 PM
    • Replies: 1
    • Views: 12,290
    20th Apr 2013, 02:28 PM Go to last post
  16. PKI based e-signatures necessary?

    Started by peglleduc, 12th Jan 2012 04:37 PM
    • Replies: 1
    • Views: 11,848
    20th Jan 2012, 12:11 PM Go to last post
  17. Subject ID Log

    Started by ztarfizh, 2nd Jul 2015 07:06 PM
    • Replies: 1
    • Views: 11,789
    9th Jul 2015, 02:50 PM Go to last post
    • Replies: 1
    • Views: 11,426
    18th Sep 2012, 03:35 PM Go to last post
  18. Physical Archiving Conditions

    Started by RS14, 14th Apr 2014 04:27 PM
    • Replies: 1
    • Views: 11,380
    30th Apr 2014, 05:18 PM Go to last post
    • Replies: 1
    • Views: 10,499
    5th Mar 2014, 12:12 PM Go to last post
  19. Physical Record Storage/Archival

    Started by scott.mcculloch, 16th Feb 2015 11:02 AM
    • Replies: 0
    • Views: 9,768
    16th Feb 2015, 11:02 AM Go to last post
    • Replies: 1
    • Views: 7,760
    8th Aug 2016, 12:41 AM Go to last post
  20. Keeping Originals / wet-ink with eTMF.

    Started by sashraf, 26th Jul 2017 02:27 PM
    • Replies: 1
    • Views: 7,402
    27th Jul 2017, 11:07 AM Go to last post
  21. Certified Copies - Approval letters received by email

    Started by Hanna, 8th Nov 2018 01:18 PM
    • Replies: 0
    • Views: 4,584
    8th Nov 2018, 01:18 PM Go to last post
  22. Paper TMF - wet ink Protocol Signatures

    Started by PHW, 20th Feb 2018 02:51 PM
    • Replies: 2
    • Views: 4,490
    1st Mar 2018, 10:57 AM Go to last post
  23. CRF retention at the end of trial

    Started by Development QA, 28th Jun 2018 10:51 AM
    • Replies: 2
    • Views: 3,060
    17th Jul 2018, 11:22 AM Go to last post
  24. Transfer of sponsor

    Started by Linda Scully, 22nd Nov 2017 01:18 PM
    • Replies: 2
    • Views: 3,012
    24th Nov 2017, 12:27 PM Go to last post
  25. Certified Colour Copies

    Started by Worky, 12th Jul 2017 04:54 PM
    • Replies: 0
    • Views: 1,956
    12th Jul 2017, 04:54 PM Go to last post
  26. Electronic and Digital signatures

    Started by PHW, 11th Jun 2018 10:59 AM
    • Replies: 0
    • Views: 1,283
    11th Jun 2018, 10:59 AM Go to last post

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