What the SEND Standard Includes

 

SEND (Standard for Exchange of Non-Clinical Data) is an implementation of the SDTM standard for nonclinical studies. SEND specifies a way to collect and present nonclinical data in a consistent format. SEND is one of the required standards for data submission to FDA.

All study data processed by the SubmitTM SEND solution (Instem) to produce one integrated SEND dataset package including Define.xml v2.0 file using DataDefine (Instem) and a Study Data Reviewer’s Guide (nsdrg). Rule conformance to standards which includes checks for conformance against published FDA Business and Validator Rules evaluated using Pinnacle 21 Community dataset validation too.

SEND’s Three Main Components

1 – definition of the structure of the standard – domains, variables, etc.

2 – a library of controlled terminology (which controls the vocabularies that can be used in some of the variables)

3 – a metadata file describing source and content of a set of SEND datasets.

Where the SEND Format is Required

The SEND requirements are continuously evolving covering increasing study types. Different versions of SENDIGs are on the Data Standards Catalog, and the submission of SEND nonclinical datasets is expected to continue to increase in the future.

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