Good Clinical Practice Guide
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Threads 1 to 30 of 41

Forum: Trial Master File (TMF) and archiving

  1. Sticky Thread Sticky: Retention of Trial Records

    Started by MHRA Super Moderator, 25th Nov 2015 01:50 PM
    • Replies: 0
    • Views: 314,447
    MHRA Super Moderator
    25th Nov 2015, 01:50 PM Go to last post

  2. 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: 631,244
    MHRA Super Moderator
    17th Dec 2012, 03:43 PM Go to last post

  1. TMF Scanning records

    Started by ML12387fjk, 17th Jun 2020 01:18 PM
    • Replies: 0
    • Views: 5,877
    ML12387fjk
    17th Jun 2020, 01:18 PM Go to last post

  2. Do we need to keep validation records for each document scanned into an eTMF?

    Started by ML12387fjk, 12th Jun 2020 09:55 AM
    • Replies: 0
    • Views: 11,161
    ML12387fjk
    12th Jun 2020, 09:55 AM Go to last post

  3. The use of institutional SharePoint bespoke site for a eTMF

    Started by mcclave, 30th Jun 2022 01:42 PM
    • Replies: 0
    • Views: 11,801
    mcclave
    30th Jun 2022, 01:42 PM Go to last post

  4. PKI based e-signatures necessary?

    Started by peglleduc, 12th Jan 2012 04:37 PM
    • Replies: 1
    • Views: 15,753
    rammellconsult
    20th Jan 2012, 12:11 PM Go to last post

  5. Requirements electronic archive

    Started by DG01, 22nd Nov 2011 01:47 PM
    • Replies: 1
    • Views: 18,221
    rammellconsult
    23rd Nov 2011, 12:08 PM Go to last post

  6. Certified Colour Copies

    Started by Worky, 12th Jul 2017 04:54 PM
    • Replies: 0
    • Views: 28,003
    Worky
    12th Jul 2017, 04:54 PM Go to last post

  7. eCRF and ePRO design - sponsor delegation log

    Started by TrialsAdvice, 7th May 2022 04:20 PM
    • Replies: 1
    • Views: 28,161
    Margit Zehrer
    30th Jun 2022, 08:58 AM Go to last post

  8. Archiving of training records

    Started by SAMMY, 19th Jan 2012 03:15 PM
    • Replies: 2
    • Views: 28,806
    SAMMY
    20th Jan 2012, 12:37 PM Go to last post

  9. Talking Shadow TMF requirements

    Started by cahill23, 16th Nov 2011 05:02 PM
    • Replies: 1
    • Views: 29,590
    rammellconsult
    17th Nov 2011, 09:26 AM Go to last post

  10. Certified Copies - Approval letters received by email

    Started by Hanna, 8th Nov 2018 01:18 PM
    • Replies: 0
    • Views: 36,658
    Hanna
    8th Nov 2018, 01:18 PM Go to last post

  11. Archive destruction when the sponsor company no longer exists

    Started by David, 10th Sep 2012 10:29 AM
    • Replies: 1
    • Views: 38,342
    rammellconsult
    18th Sep 2012, 03:35 PM Go to last post

  12. Physical Archiving Conditions

    Started by RS14, 14th Apr 2014 04:27 PM
    • Replies: 1
    • Views: 39,080
    a123456
    30th Apr 2014, 05:18 PM Go to last post

  13. Amendment 60 to 2001/20/E

    Started by Karen Goode, 19th Apr 2013 12:02 PM
    • Replies: 1
    • Views: 40,912
    a123456
    20th Apr 2013, 02:28 PM Go to last post

  14. Study documents relating to quality issues filed in the TMF

    Started by ljames16, 2nd Aug 2016 10:58 AM
    • Replies: 1
    • Views: 41,803
    Chris-H
    8th Aug 2016, 12:41 AM Go to last post

  15. Physical Record Storage/Archival

    Started by scott.mcculloch, 16th Feb 2015 11:02 AM
    • Replies: 0
    • Views: 42,309
    scott.mcculloch
    16th Feb 2015, 11:02 AM Go to last post

  16. Electronic and Digital signatures

    Started by PHW, 11th Jun 2018 10:59 AM
    • Replies: 0
    • Views: 42,450
    PHW
    11th Jun 2018, 10:59 AM Go to last post

  17. Review of Site File documentation at closure for pre-directive trials

    Started by MonitorH, 4th Mar 2014 03:57 PM
    • Replies: 1
    • Views: 43,142
    rammellconsult
    5th Mar 2014, 12:12 PM Go to last post

  18. Patient medical notes and source data

    Started by Jasper, 27th Nov 2012 08:33 AM
    • Replies: 1
    • Views: 43,306
    a123456
    27th Nov 2012, 12:34 PM Go to last post

  19. using sponsor SOP for TMF

    Started by cansel, 21st Apr 2012 07:58 AM
    • Replies: 0
    • Views: 43,571
    cansel
    21st Apr 2012, 07:58 AM Go to last post

  20. Minimum retention period for the sponsor

    Started by rammellconsult, 1st Nov 2011 02:46 PM
    • Replies: 4
    • Views: 50,686
    rammellconsult
    4th Nov 2011, 10:24 AM Go to last post

  21. Database and TMF

    Started by markepoulton, 23rd Jul 2015 01:34 PM
    • Replies: 1
    • Views: 51,087
    MHRA Moderator
    27th Jul 2015, 10:46 AM Go to last post

  22. Essential Documents and Non-Selected Sites

    Started by souderb, 30th May 2018 03:11 PM
    • Replies: 0
    • Views: 52,952
    souderb
    30th May 2018, 03:11 PM Go to last post

  23. End of Study Definition for Archiving

    Started by ztarfizh, 24th Jul 2012 10:08 AM
    • Replies: 3
    • Views: 53,915
    sonhagroup
    10th Sep 2016, 10:26 AM Go to last post

  24. Emails from Study email account to eTMF

    Started by peglleduc, 17th Feb 2012 01:46 PM
    • Replies: 2
    • Views: 56,570
    rammellconsult
    15th Oct 2014, 06:09 PM Go to last post

  25. Use of colour to decipher correspondence

    Started by Fachelray, 16th Jul 2019 12:35 PM
    • Replies: 2
    • Views: 58,954
    a123456
    15th Sep 2019, 11:10 AM Go to last post

  26. CRF retention at the end of trial

    Started by Development QA, 28th Jun 2018 10:51 AM
    • Replies: 2
    • Views: 63,271
    Development QA
    17th Jul 2018, 11:22 AM Go to last post

  27. Keeping Originals / wet-ink with eTMF.

    Started by sashraf, 26th Jul 2017 02:27 PM
    • Replies: 1
    • Views: 63,431
    rammellconsult
    27th Jul 2017, 11:07 AM Go to last post

  28. Transfer of sponsor

    Started by Linda Scully, 22nd Nov 2017 01:18 PM
    • Replies: 2
    • Views: 68,068
    a123456
    24th Nov 2017, 12:27 PM Go to last post

  29. Trial Master File in SharePoint

    Started by DG01, 23rd Nov 2011 10:39 AM
    • Replies: 4
    • Views: 68,524
    Costello
    8th Mar 2012, 01:42 AM Go to last post

  30. Paper TMF - wet ink Protocol Signatures

    Started by PHW, 20th Feb 2018 02:51 PM
    • Replies: 2
    • Views: 69,889
    Margit Zehrer
    1st Mar 2018, 10:57 AM Go to last post
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