Good Clinical Practice Guide
Threads 1 to 25 of 25

Forum: Pharmacovigilance

  1. Sticky Thread Sticky: MHRA produced FAQs for Pharmacovigilance

    Started by MHRA Super Moderator, 14th Oct 2011 10:59 AM
    • Replies: 0
    • Views: 12,656
    14th Oct 2011, 10:59 AM Go to last post
    • Replies: 4
    • Views: 41,527
    30th Jul 2012, 04:13 PM Go to last post
  1. Reference Safety Information (RSI) - annual updates

    Started by CRA, 11th Jun 2013 10:16 AM
    • Replies: 3
    • Views: 36,327
    1st Sep 2014, 10:30 AM Go to last post
  2. DSUR Non Commercial development management

    Started by Terraldinho, 1st Mar 2012 10:24 AM
    • Replies: 4
    • Views: 19,982
    12th Oct 2012, 03:41 PM Go to last post
  3. SUSAR Reporting for blinded studies

    Started by ZYunus, 23rd Nov 2011 12:58 PM
    • Replies: 1
    • Views: 18,922
    25th Feb 2012, 12:12 PM Go to last post
  4. Question Reviewing for any change to SPCs

    Started by ChrisC, 21st Dec 2016 10:58 AM
    • Replies: 4
    • Views: 16,697
    12th Jun 2017, 04:11 PM Go to last post
  5. Safety reporting for comparitors

    Started by CPi, 3rd Aug 2015 06:29 PM
    • Replies: 0
    • Views: 16,167
    3rd Aug 2015, 06:29 PM Go to last post
  6. Question SUSARs at Investigational Sites

    Started by Libra20, 21st Mar 2014 11:27 AM
    • Replies: 1
    • Views: 14,064
    22nd Mar 2014, 09:53 AM Go to last post
  7. SAE seriousness criteria - hospice admission

    Started by MTS, 24th Jan 2012 05:53 PM
    • Replies: 2
    • Views: 13,840
    2nd Jul 2015, 10:25 AM Go to last post
  8. SUSAR Reporting in the UK

    Started by SYH, 4th Jan 2012 03:34 PM
    • Replies: 1
    • Views: 13,453
    22nd Feb 2012, 05:34 PM Go to last post
  9. Delegating responsibility for assessing causality

    Started by Chris-H, 8th Aug 2016 12:35 AM
    • Replies: 2
    • Views: 12,390
    11th Aug 2016, 06:57 AM Go to last post
  10. Continued Reporting of SUSARs to Sites

    Started by ssmark, 4th Jan 2012 10:35 AM
    • Replies: 1
    • Views: 10,651
    22nd Feb 2012, 05:40 PM Go to last post
  11. Phase I Dosing and Pharmacovigilance

    Started by Nev Young, 5th Jul 2013 12:00 PM
    • Replies: 0
    • Views: 10,488
    5th Jul 2013, 12:00 PM Go to last post
  12. SUSAR reporting by EVWEB

    Started by MTS, 9th Dec 2015 05:21 PM
    • Replies: 0
    • Views: 10,308
    9th Dec 2015, 05:21 PM Go to last post
  13. requirements for faxed SAEs/AEs

    Started by PhillipsJA, 9th Oct 2014 11:35 AM
    • Replies: 0
    • Views: 9,926
    9th Oct 2014, 11:35 AM Go to last post
  14. SAE Reporting - Intensive Care setting

    Started by emma_l, 18th Jul 2016 01:22 PM
    • Replies: 0
    • Views: 6,734
    18th Jul 2016, 01:22 PM Go to last post
  15. Reference safty information - probiotic IMP

    Started by km123, 10th Feb 2017 11:56 AM
    • Replies: 0
    • Views: 3,948
    10th Feb 2017, 11:56 AM Go to last post
  16. AEs and efficacy endpoints

    Started by chiara bonardi, 17th May 2018 05:20 PM
    • Replies: 0
    • Views: 3,745
    17th May 2018, 05:20 PM Go to last post
  17. Clinical Research Training

    Started by ds3427756, 3rd Jan 2019 12:55 PM
    • Replies: 2
    • Views: 3,737
    9th Jan 2019, 12:15 PM Go to last post
  18. Pharmacovigilance Introductory training

    Started by Nadia, 4th May 2017 11:35 AM
    • Replies: 0
    • Views: 3,720
    4th May 2017, 11:35 AM Go to last post
  19. Onset date for SAE reports.

    Started by AleT, 9th Feb 2017 11:52 PM
    • Replies: 0
    • Views: 3,523
    9th Feb 2017, 11:52 PM Go to last post
  20. Toxicity Grading Criteria for Protocols

    Started by CTEnthusiast, 4th Jan 2017 10:35 AM
    • Replies: 0
    • Views: 3,513
    4th Jan 2017, 10:35 AM Go to last post
    • Replies: 0
    • Views: 2,849
    2nd Nov 2018, 10:04 AM Go to last post
  21. Non- IMPs and DSUR

    Started by Rayray123, 29th Jan 2019 11:37 AM
    • Replies: 1
    • Views: 1,486
    5th Apr 2019, 02:48 PM Go to last post
  22. RSI updates during follow-up period

    Started by HDriscoll, 25th Jan 2018 06:14 PM
    • Replies: 0
    • Views: 780
    25th Jan 2018, 06:14 PM Go to last post
  23. SAE reporting to sponsor when trial outsourced

    Started by ilyas ali, 25th Oct 2019 02:50 PM
    • Replies: 2
    • Views: 256
    3rd Nov 2019, 08:30 PM Go to last post

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