Good Clinical Practice Guide
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Threads 1 to 30 of 53

Forum: Investigational Medicinal Products (IMP)

  1. Sticky Thread Sticky: MHRA produced FAQs for Investigational Medicinal Product (IMP)

    Started by MHRA Super Moderator, 14th Oct 2011 10:58 AM
    2 Pages •
    1 2
    • Replies: 14
    • Views: 505,965
    MHRA Super Moderator
    25th Oct 2011, 10:46 AM Go to last post

  1. Expiry dates

    Started by susie, 18th Jan 2012 05:22 PM
    • Replies: 5
    • Views: 126,200
    ilyas ali
    2nd Mar 2013, 01:01 AM Go to last post

  2. IMP Transfer from one study site to another

    Started by AP78, 4th Sep 2012 11:46 AM
    • Replies: 4
    • Views: 119,708
    a123456
    6th Sep 2012, 02:51 PM Go to last post

  3. A good template for IMP Pharmacy Manuals

    Started by judith_sylvia, 24th Feb 2016 10:17 AM
    • Replies: 0
    • Views: 102,602
    judith_sylvia
    24th Feb 2016, 10:17 AM Go to last post

  4. IMP temp monitoring

    Started by susie, 2nd Nov 2011 03:18 PM
    2 Pages •
    1 2
    • Replies: 13
    • Views: 98,332
    CTU
    4th Jul 2012, 06:29 AM Go to last post

  5. Administering IMP

    Started by David, 15th Mar 2012 01:52 PM
    • Replies: 8
    • Views: 91,743
    karisoltana
    15th Dec 2021, 02:58 PM Go to last post

  6. Requirement for IB, IMPD and SmPC

    Started by ashukla, 6th Jun 2017 12:46 PM
    • Replies: 0
    • Views: 89,329
    ashukla
    6th Jun 2017, 12:46 PM Go to last post

  7. Post Dispensed expired investigational product to subject.

    Started by Bgogoi, 8th Mar 2019 09:26 AM
    • Replies: 2
    • Views: 84,200
    ilyas ali
    25th Oct 2019, 02:07 PM Go to last post

  8. Initiation Visit before IMP relaesed to Investigator Site

    Started by Sciencebird, 11th Mar 2013 04:58 PM
    • Replies: 3
    • Views: 84,007
    a123456
    2nd Apr 2013, 08:08 PM Go to last post

  9. Over-labelling of IMP

    Started by Amalia N, 4th Mar 2014 07:40 PM
    • Replies: 1
    • Views: 83,297
    @chrisbarnettQP
    22nd Jan 2016, 06:51 PM Go to last post

  10. Clinical trials labels requirements

    Started by martak, 19th Jul 2018 10:13 AM
    • Replies: 0
    • Views: 76,303
    martak
    19th Jul 2018, 10:13 AM Go to last post

  11. QP certification for IMPs exported to US

    Started by GRK, 21st Jun 2016 03:53 PM
    • Replies: 1
    • Views: 65,975
    GRK
    6th Jul 2016, 11:33 AM Go to last post

  12. IMP or NIMP

    Started by Jon, 8th Sep 2015 08:42 AM
    • Replies: 0
    • Views: 59,617
    Jon
    8th Sep 2015, 08:42 AM Go to last post

  13. Requirement for IB, IMPD and SmPC

    Started by ashukla, 6th Jun 2017 12:37 PM
    • Replies: 0
    • Views: 57,085
    ashukla
    6th Jun 2017, 12:37 PM Go to last post

  14. Temp controlled storage of IMP - Provision of Temperature logs by site

    Started by AFraser, 21st Jul 2015 12:00 PM
    • Replies: 3
    • Views: 57,062
    @chrisbarnettQP
    22nd Jan 2016, 06:39 PM Go to last post

  15. SmPcs and IB

    Started by pburns, 27th Oct 2014 11:24 AM
    • Replies: 0
    • Views: 50,199
    pburns
    27th Oct 2014, 11:24 AM Go to last post

  16. Licensed IMP used for licensed indication - accountability required?

    Started by DMcRae, 21st Aug 2013 09:38 AM
    • Replies: 1
    • Views: 46,461
    a123456
    21st Aug 2013, 01:49 PM Go to last post

  17. IMP sourcing

    Started by alex, 22nd Mar 2016 11:51 AM
    • Replies: 0
    • Views: 45,429
    alex
    22nd Mar 2016, 11:51 AM Go to last post

  18. Administration of reconstituted IMPs in subject's home by nurse

    Started by James Bateson, 5th Oct 2012 12:21 PM
    • Replies: 0
    • Views: 43,518
    James Bateson
    5th Oct 2012, 12:21 PM Go to last post

  19. MIA(IMP) Licence Holders Register

    Started by Gareth, 16th Sep 2015 09:59 AM
    • Replies: 0
    • Views: 43,428
    Gareth
    16th Sep 2015, 09:59 AM Go to last post

  20. IMP sourcing like?

    Started by tamminhduong, 21st May 2020 09:35 AM
    • Replies: 0
    • Views: 43,387
    tamminhduong
    21st May 2020, 09:35 AM Go to last post

  21. Electronic prescribing and accountability

    Started by randelle, 30th Jul 2013 02:48 PM
    • Replies: 0
    • Views: 42,338
    randelle
    30th Jul 2013, 02:48 PM Go to last post

  22. Transfer of IMP w/out PL.

    Started by PKPDQ, 20th Aug 2015 08:26 PM
    • Replies: 0
    • Views: 40,844
    PKPDQ
    20th Aug 2015, 08:26 PM Go to last post

  23. Defining the RSI for hospital commercial stock

    Started by Trial Manager, 28th Apr 2016 05:23 PM
    • Replies: 0
    • Views: 39,844
    Trial Manager
    28th Apr 2016, 05:23 PM Go to last post

  24. Change in IMP supply (Clinical to Commerial)

    Started by HDriscoll, 11th Aug 2016 12:19 PM
    • Replies: 0
    • Views: 39,653
    HDriscoll
    11th Aug 2016, 12:19 PM Go to last post

  25. Microdosing

    Started by PKPDQ, 22nd Dec 2016 11:04 AM
    • Replies: 0
    • Views: 38,760
    PKPDQ
    22nd Dec 2016, 11:04 AM Go to last post

  26. CMC Sections

    Started by markRB, 14th Mar 2014 02:50 PM
    • Replies: 0
    • Views: 38,714
    markRB
    14th Mar 2014, 02:50 PM Go to last post

  27. Investigator's writing on IMP packages

    Started by LucCo, 17th Oct 2012 10:37 AM
    • Replies: 0
    • Views: 38,473
    LucCo
    17th Oct 2012, 10:37 AM Go to last post

  28. Over labelling of IMP following unblinding

    Started by Amalia N, 4th Mar 2014 07:36 PM
    • Replies: 0
    • Views: 38,279
    Amalia N
    4th Mar 2014, 07:36 PM Go to last post

  29. IB and SUSAR rports

    Started by sally123, 17th Jun 2015 12:58 PM
    • Replies: 4
    • Views: 38,169
    MHRA Super Moderator
    7th Aug 2015, 03:00 PM Go to last post

  30. Maintaining the blind for emergency research

    Started by rach_sherman, 19th Oct 2018 11:10 AM
    • Replies: 1
    • Views: 36,808
    oblokhina
    21st Nov 2018, 01:34 PM Go to last post
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