Tuberculosis Therapeutic Area User Guide v1.0

Published Date:

Version 1.0 of the Tuberculosis Specific User Guide is a therapeutic area supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials (SDTMIG). The User Guide was developed as a joint product of the Data Standards Working Group of the Critical Path Institute’s Critical Path for TB Drug Regimens (CPTR) and CDISC’s Submissions Data Standards. It is intended to guide the organization, structure, and format of standard Tuberculosis clinical trial tabulation datasets submitted to a regulatory authority.