SENDIG v3.1 is intended to guide the organization, structure, and format of standard non-clinical tabulation datasets for interchange between organizations such as sponsors and CROs and for submission to regulatory authorities. The SENDIG v3.1 is based on, and should be used in close concert with, SDTM v1.5, which is included in the document package.
Significant changes since v3.0 include:
- The variable VISITDY has been reclassified from Expected to Permissible, and three new variables were added to relevant domains (--USCHFL, --NOMLBL, --NOMDY). VISITDY will be phased out of the SENDIG over time. An explanation of these changes and how they will develop over time is in Section 4.4.
- Two new domains for Safety Pharmacology studies have been added: Cardiovascular (CV) and Respiratory (RE); Vital Signs domain has been updated.
- New FOCID variable added to several domains (EX, CL, MA, and MI). FOCID is available to all general observation classes to specify a study-specific point of interest.
- Microscopic Findings domain updated, added three new variables (FOCID, --CHRON, --DISTR).
- Updated ECG Test Results domain, added two new Timing variables (--STINT and –ENINT).
CDISC posts Public Review comments and resolutions to ensure transparency and show implementers how comments were addressed in the standard development process.