The CDISC SEND Implementation Guide v3.1 is now available for public review.
The CDISC SEND Team is pleased to announce the SENDIG (Implementation Guide) v3.1 is now available (released 07 July 2016). The SENDIG 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 is based on and should be used in close concert with CDISC Study Data Tabulation Model (SDTM) v1.5, which is included in the document package.
Some 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).
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