Rezultati pretraživanja
  1. 21. lis 2016.

    They're here! EMA publishes first redacted CSRs. PressRelease: . View at:

  2. 13. ruj 2018.

    EMA crackdown on overdue posting: EMA is compiling a report listing Sponsors on EudraCT who are not compliant with results posting requirements. Report ready Sep 18, EMA will contact those Sponsors. Source: EMA rep at a web meeting of the DIA's "CTD Community" today.

  3. 2. lis 2016.

    EMA appeal EU Crt decision to block release of redacted CSR; CCI = grey area. Will act as 'test case':

  4. 11. lis 2018.

    Summaries of relevant regulatory and CT disclosure news are now periodically posted at: I hope you find this growing archive useful.

  5. 7. lis 2016.

    For regulatory medical writers who write CSR, you will find this useful:

  6. 26. sij

    Just propagated via the email list - and coming soon with commentary on the EMWA NewsBlast, RPD SIG page and CORE Reference News Summary page

  7. 22. svi 2017.
  8. 12. sij

    the Data Economy refers to the mass of data out there - available in this case to clinical research professionals. Pls contact me if you’d like to contribute

  9. Safeguarding the privacy of clinical trial patients - blog from following the recent publication:

  10. 19. ruj 2016.
  11. presents , a free tool for CSR writing incl proactive anonymisation tips. 4600+ downloads:

  12. 23. ožu 2017.

    How do you use ? Take the survey: . Results @EMWA_Official Conference, Birmingham UK, 04May17. Pls share

  13. 4. ruj 2019.

    Section 3 ‘Clinical trials of IMPs’: detailed info relevant for CT professionals. See my LinkedIn page for a summary:

  14. 4. velj

    Read the CORE Reference authors’ statement on the December 2019 update to the TransCelerate CSR Template, which now includes “Feedback from CORE review.”

  15. 1. velj

    detailed review T/Cel Nov 18 CSR tmplt: Dec 19 T/Cel update template + 'Summary Changes' deck: . T/Cel claim 'alignment with CORE'. T/Cel did not contact us; we have not reviewed Dec 19 template. Sam & Art

  16. 29. kol 2019.

    New 2019 CORE Reference Open Access Publication A new open access publication was published in August 2019.

  17. 6. kol 2019.

    paper Critical Review of the TransCelerate Template for CSRs and Publication of Version 2 of the (Clarity and Openness in Reporting: E3-based) Terminology Table. RIPR 2019.

  18. 1. srp 2019.

    FDA concludes clinical data summary pilot; seeks feedback on this and new integrated template to support transparency. Public comment open until 26 Aug 19:

  19. 13. pro 2018.

    TransCelerate Biopharma have released a Clinical Study Report (CSR) template (dated November 2018) which is based on ICH E3 and CORE Reference. For further information, read the CORE Reference Press Release on this topic

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