Pain Therapeutic Area User Guide v1.0

Published Date:

Version 1.0 of the Pain Therapeutic Area Supplement to the Study Data Tabulation Model Implementation Guide (SDTMIG) was developed in collaboration with 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.