August 7, 2012: Pain Database Standards Now Available on CDISC Website


The ACTTION STandardized ANalgesic DAtabase for Research, Discovery, and Submissions (STANDARDS) Working Group, in collaboration with the Clinical Data Interchange Standards Consortium (CDISC), recently completed developing a comprehensive CDISC-compliant analgesic clinical trial database structure for analgesic clinical trials. This database includes variables determined by extensive stakeholder input and from Case Report Forms provided by FDA and industry collaborators. A manuscript describing the development of the pain database standards has been submitted for publication, and the pain database standards and a user’s guide are available on the CDISC website (www.cdisc.org/therapeutic) and by a link from the ACTTION website.