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#CORERef They're here! EMA publishes first redacted CSRs. PressRelease: http://tinyurl.com/hx4rwcv . View at: https://clinicaldata.ema.europa.eu/ -
#CORERef 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. -
#CORERef EMA appeal EU Crt decision to block release of redacted CSR; CCI = grey area. Will act as 'test case': http://tinyurl.com/zsffk4n -
#CORERef#medicalwriting Summaries of relevant regulatory and CT disclosure news are now periodically posted at: https://www.core-reference.org/news-summaries/ I hope you find this growing archive useful. -
For regulatory medical writers who write CSR, you will find this useful: http://www.core-reference.org
@AmMedWriters@Official_EMWA#CORERef -
Just propagated via the
#CORERef email list - and coming soon with commentary on the EMWA NewsBlast, RPD SIG page and CORE Reference News Summary page https://www.core-reference.org/news-summaries/ https://twitter.com/AAGmedical/status/1221223300023701516 … -
#CORERef#medicalwriting author proactively-anon'ed CSRs? See@Official_EMWA Sympo: http://tinyurl.com/lrff953 Slides: http://tinyurl.com/khtuoof -
#CORERef#medicalwriting 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 contributehttps://twitter.com/Official_EMWA/status/1215567724102942720 … -
Safeguarding the privacy of clinical trial patients - blog from
@SamHamMW following the recent#CORERef publication: http://buff.ly/1VrZKb8 -
#medicalwriting. FinalRule HHS: https://www.nih.gov/news-events/news-releases/hhs-take-steps-provide-more-information-about-clinical-trials-public …. 'Results reporting reqs' will make it into next Version of#CORERef. -
@Official_EMWA presents#CORERef, a free tool for CSR writing incl proactive anonymisation tips. 4600+ downloads: http://www.core-reference.org -
How do you use
#CORERef? Take the survey: http://ow.ly/Mjdg30a9VBg . Results @EMWA_Official Conference, Birmingham UK, 04May17. Pls share -
#CORERef#clinicaltrials Section 3 ‘Clinical trials of IMPs’: detailed info relevant for CT professionals. See my LinkedIn page for a summary: https://www.linkedin.com/feed/update/urn:li:activity:6575087060368015360/ …https://twitter.com/ChrisW_PharmaG/status/1169255226056105984 … -
Read the CORE Reference authors’ statement on the December 2019 update to the TransCelerate CSR Template, which now includes “Feedback from CORE review.” https://hubs.ly/H0mTjj-0
#CORERef#medicalwriting -
#CORERef detailed review T/Cel Nov 18 CSR tmplt: http://dx.doi.org/10.1186/s41073-019-0075-5 … Dec 19 T/Cel update template + 'Summary Changes' deck: https://transceleratebiopharmainc.com/assets/clinical-content-reuse-assets/ …. T/Cel claim 'alignment with CORE'. T/Cel did not contact us; we have not reviewed Dec 19 template. Sam & Art#medicalwriting -
New 2019 CORE Reference Open Access Publication A new
#CORERef open access publication was published in August 2019. http://ow.ly/3IEy50vKKIL -
#open paper http://dx.doi.org/10.1186/s41073-019-0075-5 … Critical Review of the TransCelerate Template for CSRs and Publication of Version 2 of the#CORERef (Clarity and Openness in Reporting: E3-based) Terminology Table. RIPR 2019.#medicalwriting#clinicaltrials -
#CORERef#medicalwriting#clinicaltrials FDA concludes clinical data summary pilot; seeks feedback on this and new integrated template to support transparency. Public comment open until 26 Aug 19:https://www.federalregister.gov/documents/2019/06/27/2019-13751/new-drugs-regulatory-program-modernization-improving-approval-package-documentation-and … -
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
#CORERef http://ow.ly/rkG930mWiTd -
#CORERef#clinicaldatadisclosure#medicalwriting New EMA Clinical data publication page: https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/clinical-data-publication … V4 (09nov18) Pol 70 implementation guidance: https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/clinical-data-publication/support-industry/external-guidance-implementation-european-medicines-agency-policy-publication-clinical-data … Support for industry on clinical data publication:https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/clinical-data-publication/support-industry-clinical-data-publication …
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