The Making of a CDISC Trainer

Posted by Cytel

Feb 6, 2017 9:10:00 AM

 

CDISC is a global, nonprofit charitable organization whose mission is ‘to inform patient care and safety through higher quality medical research’.  The organization delivers this mission through the development of data standards designed to streamline clinical research- these standard formats are increasingly expected for use in data submissions by regulatory authorities. Importantly, data...

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Topics: Clinical Data, Biometrics, Statistical Programming, CDISC, CDASH, SDTM, ADaM, Training and Education


CDISC submissions- are you up to speed?

Posted by Cytel

Dec 21, 2016 9:45:00 AM

 

December 18th 2016 was a significant date for the pharmaceutical industry and regulatory submissions. For trials which commence after this date, the FDA will no longer accept non-CDISC data submissions for new drug applications ( NDAs) , certain investigational new drug applications, abbreviated new drug applications (ANDAs)  and certain biologics license applications (BLAs).

 The FDA...

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Topics: Clinical Data, data manager, SDTM, CDISC, CDASH, Regulation


How do CDASH standards build data quality?

Posted by Cytel

Dec 20, 2016 9:21:00 AM

 

Data Standards play a crucial role in structuring and promoting long term value of clinical data.

Clinical Data Acquisitions Standards Harmonization or CDASH was developed with participation from all three ICH regions (US, Europe and Japan) with recommended data collection fields for 16 domains-> DEMOG, AE etc. It also includes  implementation guidelines, best practice recommendations, and...

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Topics: Clinical Data, data manager, SDTM, CDISC, CDASH


The CRO role in Data Standards Governance

Posted by Cytel

Aug 2, 2016 10:30:00 AM

Editor's note( this blog was refreshed in April 2018)

As CDISC compliant submissions become increasingly expected, biopharmaceutical companies are considering how to approach the issue of data standards governance.  Standards governance is a lynchpin in the management of CDISC compliance and is important for promoting standards awareness within organizations. It’s also an acknowledged hot...

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Topics: Data Management, Clinical Research Services, Clinical Data, EDC, database build, data manager, CDM, Statistical Programming, SDTM, ADaM, CDISC, CDASH


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