Good Clinical Practice Guide
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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: 501,055
    MHRA Super Moderator
    25th Oct 2011, 10:46 AM Go to last post

  1. Why temperature monitoring is so important for IMP

    Started by ilyas ali, 17th Mar 2012 01:20 AM
    • Replies: 1
    • Views: 21,682
    MHRA Moderator
    20th Mar 2012, 10:53 AM Go to last post

  2. Using two devices for monitoring temperature

    Started by ilyas ali, 28th May 2012 12:47 AM
    • Replies: 1
    • Views: 11,732
    a123456
    30th May 2012, 07:56 PM Go to last post

  3. Unavailability of QP release certificate from Sponsor

    Started by ilyas ali, 29th Feb 2012 12:22 AM
    • Replies: 1
    • Views: 10,423
    MHRA Moderator
    20th Mar 2012, 11:22 AM Go to last post

  4. Transfer of IMP w/out PL.

    Started by PKPDQ, 20th Aug 2015 08:26 PM
    • Replies: 0
    • Views: 40,585
    PKPDQ
    20th Aug 2015, 08:26 PM Go to last post

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

    Started by AFraser, 21st Jul 2015 12:00 PM
    • Replies: 3
    • Views: 56,755
    @chrisbarnettQP
    22nd Jan 2016, 06:39 PM Go to last post

  6. Smile Switching an Import Licence

    Started by COL79, 12th Dec 2011 10:20 PM
    • Replies: 0
    • Views: 7,491
    COL79
    12th Dec 2011, 10:20 PM Go to last post

  7. Exclamation Storage of investigational product and serum samples within the same freezer.

    Started by PedanticResearcher, 15th Sep 2023 02:15 PM
    • Replies: 0
    • Views: 8,323
    PedanticResearcher
    15th Sep 2023, 02:15 PM Go to last post

  8. SmPcs and IB

    Started by pburns, 27th Oct 2014 11:24 AM
    • Replies: 0
    • Views: 49,944
    pburns
    27th Oct 2014, 11:24 AM Go to last post

  9. Requirement for IB, IMPD and SmPC

    Started by ashukla, 6th Jun 2017 12:37 PM
    • Replies: 0
    • Views: 56,477
    ashukla
    6th Jun 2017, 12:37 PM Go to last post

  10. Requirement for IB, IMPD and SmPC

    Started by ashukla, 6th Jun 2017 12:46 PM
    • Replies: 0
    • Views: 88,973
    ashukla
    6th Jun 2017, 12:46 PM Go to last post

  11. Reconstituted unused IMP

    Started by ecsy911, 19th Apr 2017 03:43 PM
    • Replies: 0
    • Views: 25,216
    ecsy911
    19th Apr 2017, 03:43 PM Go to last post

  12. Re-packing of Non IMP

    Started by ilyas ali, 30th Nov 2011 11:25 PM
    • Replies: 2
    • Views: 11,531
    MHRA Moderator
    20th Jan 2012, 11:40 AM Go to last post

  13. QP certification for IMPs exported to US

    Started by GRK, 21st Jun 2016 03:53 PM
    • Replies: 1
    • Views: 64,979
    GRK
    6th Jul 2016, 11:33 AM Go to last post

  14. Preparation of IMP for Infusion

    Started by Sharne, 23rd Oct 2019 07:45 PM
    • Replies: 0
    • Views: 34,244
    Sharne
    23rd Oct 2019, 07:45 PM Go to last post

  15. Pharmacy Registration status to conduct Clinical trials

    Started by annabowron, 8th Jan 2013 01:57 PM
    • Replies: 0
    • Views: 31,527
    annabowron
    8th Jan 2013, 01:57 PM Go to last post

  16. Over-labelling of IMP

    Started by Amalia N, 4th Mar 2014 07:40 PM
    • Replies: 1
    • Views: 82,023
    @chrisbarnettQP
    22nd Jan 2016, 06:51 PM Go to last post

  17. Over labelling of IMP following unblinding

    Started by Amalia N, 4th Mar 2014 07:36 PM
    • Replies: 0
    • Views: 38,005
    Amalia N
    4th Mar 2014, 07:36 PM Go to last post

  18. NIMP in trial being used off license - is this ok?

    Started by pgamble, 10th Sep 2012 02:14 PM
    • Replies: 0
    • Views: 13,948
    pgamble
    10th Sep 2012, 02:14 PM Go to last post

  19. Monitoring of temperature during transportation from depot to site.

    Started by ilyas ali, 8th Mar 2012 08:39 PM
    • Replies: 1
    • Views: 11,945
    MHRA Moderator
    23rd Apr 2012, 09:33 AM Go to last post

  20. Microdosing

    Started by PKPDQ, 22nd Dec 2016 11:04 AM
    • Replies: 0
    • Views: 38,541
    PKPDQ
    22nd Dec 2016, 11:04 AM Go to last post

  21. MIA(IMP) Licence Holders Register

    Started by Gareth, 16th Sep 2015 09:59 AM
    • Replies: 0
    • Views: 43,166
    Gareth
    16th Sep 2015, 09:59 AM Go to last post

  22. Maintaining the blind for emergency research

    Started by rach_sherman, 19th Oct 2018 11:10 AM
    • Replies: 1
    • Views: 36,562
    oblokhina
    21st Nov 2018, 01:34 PM Go to last post

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

    Started by DMcRae, 21st Aug 2013 09:38 AM
    • Replies: 1
    • Views: 46,073
    a123456
    21st Aug 2013, 01:49 PM Go to last post

  24. Labelling of APIs

    Started by JK1982, 28th Feb 2017 09:42 AM
    • Replies: 0
    • Views: 34,506
    JK1982
    28th Feb 2017, 09:42 AM Go to last post

  25. IV IMP labelling requirements

    Started by Victoria Poole, 24th Jan 2012 05:17 PM
    • Replies: 2
    • Views: 9,873
    susie
    27th Jan 2012, 09:22 AM Go to last post

  26. Investigator's writing on IMP packages

    Started by LucCo, 17th Oct 2012 10:37 AM
    • Replies: 0
    • Views: 38,331
    LucCo
    17th Oct 2012, 10:37 AM Go to last post

  27. Initiation Visit before IMP relaesed to Investigator Site

    Started by Sciencebird, 11th Mar 2013 04:58 PM
    • Replies: 3
    • Views: 82,759
    a123456
    2nd Apr 2013, 08:08 PM Go to last post

  28. IMPs and same/different batch

    Started by Dr. Praveena Pearl, 11th Sep 2012 09:12 AM
    • Replies: 1
    • Views: 27,927
    a123456
    21st Sep 2012, 05:13 PM Go to last post

  29. IMP Transfer from one study site to another

    Started by AP78, 4th Sep 2012 11:46 AM
    • Replies: 4
    • Views: 118,581
    a123456
    6th Sep 2012, 02:51 PM Go to last post

  30. IMP temp monitoring

    Started by susie, 2nd Nov 2011 03:18 PM
    2 Pages •
    1 2
    • Replies: 13
    • Views: 96,969
    CTU
    4th Jul 2012, 06:29 AM Go to last post
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