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: 516,372
    MHRA Super Moderator
    25th Oct 2011, 10:46 AM Go to last post

  1. IMP temp monitoring

    Started by susie, 2nd Nov 2011 03:18 PM
    2 Pages •
    1 2
    • Replies: 13
    • Views: 101,412
    CTU
    4th Jul 2012, 06:29 AM Go to last post

  2. Administering IMP

    Started by David, 15th Mar 2012 01:52 PM
    • Replies: 8
    • Views: 94,813
    karisoltana
    15th Dec 2021, 02:58 PM Go to last post

  3. Expiry dates

    Started by susie, 18th Jan 2012 05:22 PM
    • Replies: 5
    • Views: 129,170
    ilyas ali
    2nd Mar 2013, 01:01 AM Go to last post

  4. IMP Transfer from one study site to another

    Started by AP78, 4th Sep 2012 11:46 AM
    • Replies: 4
    • Views: 122,060
    a123456
    6th Sep 2012, 02:51 PM Go to last post

  5. IB and SUSAR rports

    Started by sally123, 17th Jun 2015 12:58 PM
    • Replies: 4
    • Views: 39,459
    MHRA Super Moderator
    7th Aug 2015, 03:00 PM Go to last post

  6. Initiation Visit before IMP relaesed to Investigator Site

    Started by Sciencebird, 11th Mar 2013 04:58 PM
    • Replies: 3
    • Views: 87,025
    a123456
    2nd Apr 2013, 08:08 PM Go to last post

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

    Started by AFraser, 21st Jul 2015 12:00 PM
    • Replies: 3
    • Views: 58,305
    @chrisbarnettQP
    22nd Jan 2016, 06:39 PM Go to last post

  8. Central Monitoring of IMP Storage

    Started by KMarley, 21st Nov 2011 06:02 PM
    • Replies: 2
    • Views: 17,859
    khalilc
    2nd Aug 2012, 02:10 PM Go to last post

  9. Re-packing of Non IMP

    Started by ilyas ali, 30th Nov 2011 11:25 PM
    • Replies: 2
    • Views: 11,758
    MHRA Moderator
    20th Jan 2012, 11:40 AM Go to last post

  10. IV IMP labelling requirements

    Started by Victoria Poole, 24th Jan 2012 05:17 PM
    • Replies: 2
    • Views: 10,088
    susie
    27th Jan 2012, 09:22 AM Go to last post

  11. Post Dispensed expired investigational product to subject.

    Started by Bgogoi, 8th Mar 2019 09:26 AM
    • Replies: 2
    • Views: 87,419
    ilyas ali
    25th Oct 2019, 02:07 PM Go to last post

  12. Comparator Drugs

    Started by ADAllen, 11th Nov 2011 01:44 PM
    • Replies: 1
    • Views: 11,284
    pburns
    17th Nov 2011, 03:13 PM Go to last post

  13. EU marketed drug unlicenced in UK and used as an IMP

    Started by Linda Collins, 16th Feb 2012 04:57 PM
    • Replies: 1
    • Views: 9,243
    ilyas ali
    29th Feb 2012, 12:15 AM Go to last post

  14. Unavailability of QP release certificate from Sponsor

    Started by ilyas ali, 29th Feb 2012 12:22 AM
    • Replies: 1
    • Views: 10,610
    MHRA Moderator
    20th Mar 2012, 11:22 AM Go to last post

  15. Why temperature monitoring is so important for IMP

    Started by ilyas ali, 17th Mar 2012 01:20 AM
    • Replies: 1
    • Views: 24,826
    MHRA Moderator
    20th Mar 2012, 10:53 AM Go to last post

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

    Started by ilyas ali, 8th Mar 2012 08:39 PM
    • Replies: 1
    • Views: 12,169
    MHRA Moderator
    23rd Apr 2012, 09:33 AM Go to last post

  17. Using two devices for monitoring temperature

    Started by ilyas ali, 28th May 2012 12:47 AM
    • Replies: 1
    • Views: 11,964
    a123456
    30th May 2012, 07:56 PM Go to last post

  18. IMPs and same/different batch

    Started by Dr. Praveena Pearl, 11th Sep 2012 09:12 AM
    • Replies: 1
    • Views: 28,625
    a123456
    21st Sep 2012, 05:13 PM Go to last post

  19. Over-labelling of IMP

    Started by Amalia N, 4th Mar 2014 07:40 PM
    • Replies: 1
    • Views: 86,187
    @chrisbarnettQP
    22nd Jan 2016, 06:51 PM Go to last post

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

    Started by DMcRae, 21st Aug 2013 09:38 AM
    • Replies: 1
    • Views: 47,846
    a123456
    21st Aug 2013, 01:49 PM Go to last post

  21. QP certification for IMPs exported to US

    Started by GRK, 21st Jun 2016 03:53 PM
    • Replies: 1
    • Views: 68,404
    GRK
    6th Jul 2016, 11:33 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: 37,789
    oblokhina
    21st Nov 2018, 01:34 PM Go to last post

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

    Started by pgamble, 10th Sep 2012 02:14 PM
    • Replies: 0
    • Views: 14,395
    pgamble
    10th Sep 2012, 02:14 PM Go to last post

  24. IMP dispensing from a premises which is not a registered Pharmacy

    Started by khalilc, 2nd Aug 2012 10:56 AM
    • Replies: 0
    • Views: 15,878
    khalilc
    2nd Aug 2012, 10:56 AM Go to last post

  25. SmPcs and IB

    Started by pburns, 27th Oct 2014 11:24 AM
    • Replies: 0
    • Views: 51,253
    pburns
    27th Oct 2014, 11:24 AM Go to last post

  26. Transfer of IMP w/out PL.

    Started by PKPDQ, 20th Aug 2015 08:26 PM
    • Replies: 0
    • Views: 41,861
    PKPDQ
    20th Aug 2015, 08:26 PM Go to last post

  27. Over labelling of IMP following unblinding

    Started by Amalia N, 4th Mar 2014 07:36 PM
    • Replies: 0
    • Views: 39,390
    Amalia N
    4th Mar 2014, 07:36 PM Go to last post

  28. CMC Sections

    Started by markRB, 14th Mar 2014 02:50 PM
    • Replies: 0
    • Views: 39,789
    markRB
    14th Mar 2014, 02:50 PM Go to last post

  29. IMP or NIMP

    Started by Jon, 8th Sep 2015 08:42 AM
    • Replies: 0
    • Views: 60,772
    Jon
    8th Sep 2015, 08:42 AM Go to last post

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

    Started by PedanticResearcher, 15th Sep 2023 02:15 PM
    • Replies: 0
    • Views: 8,394
    PedanticResearcher
    15th Sep 2023, 02:15 PM Go to last post
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