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Regulatory Documents (FDA, EMA, etc.)

CDISC updates this page regularly with papers and announcements from the regulatory authorities, however readers should check for new announcements directly with the agency concerned.

 

Attention

A new document about CDER Data Standards has just been posted on the FDA website.  Please click here to access to document directly.

 

EMA released the Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials as 'adopted' on 1 August 2010. This references the eSDI Document.

 

Submission of Data in CDISC Format-both SDTM and ADaM-to CBER

 

SDTM and ADaM are being accepted by CBER effective December 15, 2010.  Amy Malla is the Point of Contact for all CDISC related questions at CBER.

 

Please ensure you have read the information posted on the CBER website before making any submissions to CBER.