Pain Therapeutic Area User Guide v1.1
General updates include: document adapted to the CDISC Wiki environment, errata identified for versions 1.0 incorporated, concept maps updated to conform to current practice, organizational updates and modeling changes.
Pain Therapeutic Area User Guide v1.0
Version 1.0 Provisional of the Pain Therapeutic Area Supplement to the Study Data Tabulation Model Implementation Guide (SDTMIG), released 2012-08-07, was developed in collaboration between CDISC and the Analgesic Clinical Trial Translations Innovations, Opportunities, and Networks (ACTTION). When used with the SDTMIG, this Supplement is intended to guide the organization, structure, and format of standard pain clinical trial tabulation datasets for regulatory submission.
|Pain Therapeutic Area User Guide v1||4.15 MB|