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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: 569,945
    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: 286,746
    25th Nov 2015, 01:50 PM Go to last post
  1. Amendment 60 to 2001/20/E

    Started by Karen Goode, 19th Apr 2013 12:02 PM
    • Replies: 1
    • Views: 40,006
    20th Apr 2013, 02:28 PM Go to last post
    • Replies: 1
    • Views: 37,695
    18th Sep 2012, 03:35 PM Go to last post
  2. Archiving of training records

    Started by SAMMY, 19th Jan 2012 03:15 PM
    • Replies: 2
    • Views: 28,269
    20th Jan 2012, 12:37 PM Go to last post
  3. Certified Colour Copies

    Started by Worky, 12th Jul 2017 04:54 PM
    • Replies: 0
    • Views: 27,248
    12th Jul 2017, 04:54 PM Go to last post
  4. Certified Copies - Approval letters received by email

    Started by Hanna, 8th Nov 2018 01:18 PM
    • Replies: 0
    • Views: 35,475
    8th Nov 2018, 01:18 PM Go to last post
  5. Collection of Lab Director's CVs for Local Labs

    Started by S1smith, 30th Oct 2020 03:13 PM
    • Replies: 0
    • Views: 77,396
    30th Oct 2020, 03:13 PM Go to last post
  6. CRF retention at the end of trial

    Started by Development QA, 28th Jun 2018 10:51 AM
    • Replies: 2
    • Views: 61,980
    17th Jul 2018, 11:22 AM Go to last post
  7. 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
    • Replies: 0
    • Views: 10,686
    12th Jun 2020, 09:55 AM Go to last post
  8. Does the MHRA hate file notes?

    Started by Trial Manager, 5th Sep 2016 03:25 PM
    • Replies: 4
    • Views: 87,624
    28th Sep 2016, 12:50 AM Go to last post
  9. eCRF and ePRO design - sponsor delegation log

    Started by TrialsAdvice, 7th May 2022 04:20 PM
    • Replies: 1
    • Views: 22,999
    30th Jun 2022, 08:58 AM Go to last post
  10. Electronic and Digital signatures

    Started by PHW, 11th Jun 2018 10:59 AM
    • Replies: 0
    • Views: 41,532
    11th Jun 2018, 10:59 AM Go to last post
  11. Electronic archiving of ISFs and E-CRFs

    Started by Fachelray, 6th Mar 2019 12:11 PM
    • Replies: 1
    • Views: 112,159
    7th Mar 2019, 10:15 AM Go to last post
  12. Emails from Study email account to eTMF

    Started by peglleduc, 17th Feb 2012 01:46 PM
    • Replies: 2
    • Views: 55,072
    15th Oct 2014, 06:09 PM Go to last post
  13. End of Study Definition for Archiving

    Started by ztarfizh, 24th Jul 2012 10:08 AM
    • Replies: 3
    • Views: 52,597
    10th Sep 2016, 10:26 AM Go to last post
  14. Essential Documents and Non-Selected Sites

    Started by souderb, 30th May 2018 03:11 PM
    • Replies: 0
    • Views: 51,788
    30th May 2018, 03:11 PM Go to last post
    • Replies: 4
    • Views: 79,051
    6th Sep 2018, 07:34 PM Go to last post
  15. Keeping Originals / wet-ink with eTMF.

    Started by sashraf, 26th Jul 2017 02:27 PM
    • Replies: 1
    • Views: 54,789
    27th Jul 2017, 11:07 AM Go to last post
  16. MHRA blog on the trial master file (TMF)

    Started by MHRA, 30th Jul 2015 05:10 PM
    • Replies: 0
    • Views: 78,120
    30th Jul 2015, 05:10 PM Go to last post
  17. Minimum retention period for the sponsor

    Started by rammellconsult, 1st Nov 2011 02:46 PM
    • Replies: 4
    • Views: 43,820
    4th Nov 2011, 10:24 AM Go to last post
  18. Mixing ink and digital signatures

    Started by Heather, 11th Aug 2015 02:33 PM
    • Replies: 1
    • Views: 149,394
    27th Nov 2015, 11:44 AM Go to last post
  19. Paper TMF - wet ink Protocol Signatures

    Started by PHW, 20th Feb 2018 02:51 PM
    • Replies: 2
    • Views: 65,394
    1st Mar 2018, 10:57 AM Go to last post
  20. Patient medical notes and source data

    Started by Jasper, 27th Nov 2012 08:33 AM
    • Replies: 1
    • Views: 42,400
    27th Nov 2012, 12:34 PM Go to last post
  21. Physical Archiving Conditions

    Started by RS14, 14th Apr 2014 04:27 PM
    • Replies: 1
    • Views: 38,180
    30th Apr 2014, 05:18 PM Go to last post
  22. Physical Record Storage/Archival

    Started by scott.mcculloch, 16th Feb 2015 11:02 AM
    • Replies: 0
    • Views: 41,453
    16th Feb 2015, 11:02 AM Go to last post
  23. PKI based e-signatures necessary?

    Started by peglleduc, 12th Jan 2012 04:37 PM
    • Replies: 1
    • Views: 15,388
    20th Jan 2012, 12:11 PM Go to last post
  24. Redacting patient identifiers for research archiving

    Started by BasseyK, 12th Jun 2019 08:33 AM
    • Replies: 1
    • Views: 72,346
    14th Jun 2019, 07:42 PM Go to last post
  25. Requirements electronic archive

    Started by DG01, 22nd Nov 2011 01:47 PM
    • Replies: 1
    • Views: 17,894
    23rd Nov 2011, 12:08 PM Go to last post
    • Replies: 1
    • Views: 42,163
    5th Mar 2014, 12:12 PM Go to last post
  26. Screening Log & Identifiable information

    Started by samyangnudle, 5th Apr 2019 04:19 PM
    • Replies: 1
    • Views: 133,249
    16th Apr 2019, 03:36 PM Go to last post

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