Good Clinical Practice Guide
Threads 1 to 22 of 22

Forum: Pharmacovigilance

  1. Sticky Thread Sticky: MHRA produced FAQs for Pharmacovigilance

    Started by MHRA Super Moderator, 14th Oct 2011 11:59 AM
    • Replies: 0
    • Views: 12,005
    14th Oct 2011, 11:59 AM Go to last post
    • Replies: 4
    • Views: 40,349
    30th Jul 2012, 05:13 PM Go to last post
  1. Reference Safety Information (RSI) - annual updates

    Started by CRA, 11th Jun 2013 11:16 AM
    • Replies: 3
    • Views: 32,353
    1st Sep 2014, 11:30 AM Go to last post
  2. DSUR Non Commercial development management

    Started by Terraldinho, 1st Mar 2012 10:24 AM
    • Replies: 4
    • Views: 18,770
    12th Oct 2012, 04:41 PM Go to last post
  3. SUSAR Reporting for blinded studies

    Started by ZYunus, 23rd Nov 2011 12:58 PM
    • Replies: 1
    • Views: 17,353
    25th Feb 2012, 12:12 PM Go to last post
  4. Safety reporting for comparitors

    Started by CPi, 3rd Aug 2015 07:29 PM
    • Replies: 0
    • Views: 15,485
    3rd Aug 2015, 07:29 PM Go to last post
  5. Question Reviewing for any change to SPCs

    Started by ChrisC, 21st Dec 2016 10:58 AM
    • Replies: 4
    • Views: 15,193
    12th Jun 2017, 05:11 PM Go to last post
  6. SAE seriousness criteria - hospice admission

    Started by MTS, 24th Jan 2012 05:53 PM
    • Replies: 2
    • Views: 12,996
    2nd Jul 2015, 11:25 AM Go to last post
  7. Question SUSARs at Investigational Sites

    Started by Libra20, 21st Mar 2014 11:27 AM
    • Replies: 1
    • Views: 12,458
    22nd Mar 2014, 09:53 AM Go to last post
  8. SUSAR Reporting in the UK

    Started by SYH, 4th Jan 2012 03:34 PM
    • Replies: 1
    • Views: 12,428
    22nd Feb 2012, 05:34 PM Go to last post
  9. Delegating responsibility for assessing causality

    Started by Chris-H, 8th Aug 2016 01:35 AM
    • Replies: 2
    • Views: 11,459
    11th Aug 2016, 07:57 AM Go to last post
  10. Continued Reporting of SUSARs to Sites

    Started by ssmark, 4th Jan 2012 10:35 AM
    • Replies: 1
    • Views: 9,962
    22nd Feb 2012, 05:40 PM Go to last post
  11. Phase I Dosing and Pharmacovigilance

    Started by Nev Young, 5th Jul 2013 01:00 PM
    • Replies: 0
    • Views: 9,655
    5th Jul 2013, 01:00 PM Go to last post
  12. SUSAR reporting by EVWEB

    Started by MTS, 9th Dec 2015 05:21 PM
    • Replies: 0
    • Views: 9,563
    9th Dec 2015, 05:21 PM Go to last post
  13. requirements for faxed SAEs/AEs

    Started by PhillipsJA, 9th Oct 2014 12:35 PM
    • Replies: 0
    • Views: 9,343
    9th Oct 2014, 12:35 PM Go to last post
  14. SAE Reporting - Intensive Care setting

    Started by emma_l, 18th Jul 2016 02:22 PM
    • Replies: 0
    • Views: 6,196
    18th Jul 2016, 02:22 PM Go to last post
  15. Reference safty information - probiotic IMP

    Started by km123, 10th Feb 2017 11:56 AM
    • Replies: 0
    • Views: 3,305
    10th Feb 2017, 11:56 AM Go to last post
  16. Pharmacovigilance Introductory training

    Started by Nadia, 4th May 2017 12:35 PM
    • Replies: 0
    • Views: 3,138
    4th May 2017, 12:35 PM Go to last post
  17. AEs and efficacy endpoints

    Started by chiara bonardi, 17th May 2018 06:20 PM
    • Replies: 0
    • Views: 3,052
    17th May 2018, 06:20 PM Go to last post
  18. Toxicity Grading Criteria for Protocols

    Started by CTEnthusiast, 4th Jan 2017 10:35 AM
    • Replies: 0
    • Views: 2,925
    4th Jan 2017, 10:35 AM Go to last post
  19. Onset date for SAE reports.

    Started by AleT, 9th Feb 2017 11:52 PM
    • Replies: 0
    • Views: 2,735
    9th Feb 2017, 11:52 PM Go to last post
    • Replies: 0
    • Views: 1,251
    2nd Nov 2018, 10:04 AM Go to last post
  20. RSI updates during follow-up period

    Started by HDriscoll, 25th Jan 2018 06:14 PM
    • Replies: 0
    • Views: 270
    25th Jan 2018, 06:14 PM Go to last post

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