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: 133,366
    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: 37,777
    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: 30,553
    4th Nov 2011, 10:24 AM Go to last post
  2. Trial Master File in SharePoint

    Started by DG01, 23rd Nov 2011 10:39 AM
    • Replies: 4
    • Views: 20,121
    8th Mar 2012, 01:42 AM Go to last post
    • Replies: 4
    • Views: 19,235
    6th Sep 2018, 07:34 PM Go to last post
  3. Does the MHRA hate file notes?

    Started by Trial Manager, 5th Sep 2016 03:25 PM
    • Replies: 4
    • Views: 23,670
    28th Sep 2016, 12:50 AM Go to last post
  4. End of Study Definition for Archiving

    Started by ztarfizh, 24th Jul 2012 10:08 AM
    • Replies: 3
    • Views: 18,523
    10th Sep 2016, 10:26 AM Go to last post
  5. Emails from Study email account to eTMF

    Started by peglleduc, 17th Feb 2012 01:46 PM
    • Replies: 2
    • Views: 15,647
    15th Oct 2014, 06:09 PM Go to last post
  6. Archiving of training records

    Started by SAMMY, 19th Jan 2012 03:15 PM
    • Replies: 2
    • Views: 13,878
    20th Jan 2012, 12:37 PM Go to last post
  7. TMF Index

    Started by AP78, 30th Aug 2012 08:56 AM
    • Replies: 2
    • Views: 16,125
    31st Aug 2012, 12:09 PM Go to last post
  8. CRF retention at the end of trial

    Started by Development QA, 28th Jun 2018 10:51 AM
    • Replies: 2
    • Views: 4,295
    17th Jul 2018, 11:22 AM Go to last post
  9. Use of colour to decipher correspondence

    Started by Fachelray, 16th Jul 2019 12:35 PM
    • Replies: 2
    • Views: 3,757
    15th Sep 2019, 11:10 AM Go to last post
  10. Transfer of sponsor

    Started by Linda Scully, 22nd Nov 2017 01:18 PM
    • Replies: 2
    • Views: 4,499
    24th Nov 2017, 12:27 PM Go to last post
  11. Paper TMF - wet ink Protocol Signatures

    Started by PHW, 20th Feb 2018 02:51 PM
    • Replies: 2
    • Views: 6,161
    1st Mar 2018, 10:57 AM Go to last post
  12. Requirements electronic archive

    Started by DG01, 22nd Nov 2011 01:47 PM
    • Replies: 1
    • Views: 14,433
    23rd Nov 2011, 12:08 PM Go to last post
  13. Talking Shadow TMF requirements

    Started by cahill23, 16th Nov 2011 05:02 PM
    • Replies: 1
    • Views: 13,918
    17th Nov 2011, 09:26 AM Go to last post
  14. PKI based e-signatures necessary?

    Started by peglleduc, 12th Jan 2012 04:37 PM
    • Replies: 1
    • Views: 12,475
    20th Jan 2012, 12:11 PM Go to last post
    • Replies: 1
    • Views: 12,261
    18th Sep 2012, 03:35 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: 13,376
    20th Apr 2013, 02:28 PM Go to last post
  16. Patient medical notes and source data

    Started by Jasper, 27th Nov 2012 08:33 AM
    • Replies: 1
    • Views: 17,409
    27th Nov 2012, 12:34 PM Go to last post
  17. Mixing ink and digital signatures

    Started by Heather, 11th Aug 2015 02:33 PM
    • Replies: 1
    • Views: 26,765
    27th Nov 2015, 11:44 AM Go to last post
    • Replies: 1
    • Views: 11,515
    5th Mar 2014, 12:12 PM Go to last post
  18. Physical Archiving Conditions

    Started by RS14, 14th Apr 2014 04:27 PM
    • Replies: 1
    • Views: 12,312
    30th Apr 2014, 05:18 PM Go to last post
  19. Subject ID Log

    Started by ztarfizh, 2nd Jul 2015 07:06 PM
    • Replies: 1
    • Views: 13,366
    9th Jul 2015, 02:50 PM Go to last post
  20. Database and TMF

    Started by markepoulton, 23rd Jul 2015 01:34 PM
    • Replies: 1
    • Views: 14,432
    27th Jul 2015, 10:46 AM Go to last post
    • Replies: 1
    • Views: 9,016
    8th Aug 2016, 12:41 AM Go to last post
  21. Electronic archiving of ISFs and E-CRFs

    Started by Fachelray, 6th Mar 2019 12:11 PM
    • Replies: 1
    • Views: 1,973
    7th Mar 2019, 10:15 AM Go to last post
  22. Screening Log & Identifiable information

    Started by samyangnudle, 5th Apr 2019 04:19 PM
    • Replies: 1
    • Views: 2,317
    16th Apr 2019, 03:36 PM Go to last post
  23. Redacting patient identifiers for research archiving

    Started by BasseyK, 12th Jun 2019 08:33 AM
    • Replies: 1
    • Views: 4,353
    14th Jun 2019, 07:42 PM Go to last post
  24. Keeping Originals / wet-ink with eTMF.

    Started by sashraf, 26th Jul 2017 02:27 PM
    • Replies: 1
    • Views: 8,982
    27th Jul 2017, 11:07 AM Go to last post
  25. Site staff CVs in TMF?

    Started by KCH, 20th Nov 2017 05:46 PM
    • Replies: 1
    • Views: 13,429
    1st Oct 2019, 08:21 PM Go to last post
  26. Electronic and Digital signatures

    Started by PHW, 11th Jun 2018 10:59 AM
    • Replies: 0
    • Views: 2,190
    11th Jun 2018, 10:59 AM Go to last post

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