Standard for Exchange of Nonclinical Data (SEND)
SEND 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.
Details on the requirements for FDA are specified in the FDA’s Data Standards Catalog for NDA, ANDA, and certain BLA submissions. For more information, please visit the FDA Guidance on Standardized Data.
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.
Version 3.0 of SENDIG is intended to guide the organization, structure, and format of standard nonclinical tabulation datasets for interchange between organizations such as sponsors and CROs and for submission to regulatory authorities. Version 3.0 of the SENDIG is designed to support single-dose general toxicology, repeat-dose general toxicology, and carcinogenicity studies. The SENDIG is based on, and should be used in close concert with, SDTM v1.2.
For a better understanding of the study endpoints that can be confidently exchanged using the SENDIG v3.0, the SEND development team released a supplemental document, Confirmed Data Endpoints for SENDIG v3.0 Data Exchange (CoDEx 1.0 for SEND v3.0) on 16 Aug 2017
SENDIG-Developmental and Reproductive Toxicology (DART) v1.1 (Final)
Version 1.1 of the SENDIG-DART includes revisions to DART variables introduced in the provisional version as well as other revisions based on SDTM v1.6. To understand all changes, please see Appendix F Revision History. SENDIG-DART v1.1 supports study data typically found in embryo-fetal developmental (EFD) toxicity studies and is based on, and should be used in close concert with, SEND v 3.1 and SDTM v1.6. While SENDIG-DART v1.1 focuses on EFD toxicity, other study designs will be covered in future releases.
Metadata files, as well as a Diff file, which summarizes the changes from SENDIG-DART v1.0 to SENDIG-DART v1.1, including new, updated and deprecated/removed content, are available to CDISC Members from CDISC SHARE Exports. If you are an employee of a CDISC Member Organization, you can access this metadata by logging into your account and visiting the Members Only Area in the upper right-hand corner of the web site.
SENDIG: Developmental and Reproductive Toxicology (DART) v1.0 (Provisional)
Version 1.0 of SENDIG-DART is available for provisional use and supports study data typically found in embryo-fetal developmental (EFD) toxicity studies. It is based on, and should be used in accordance with, the SENDIG v3.1 for single-dose general toxicology, repeat-dose general toxicology, and carcinogenicity studies. While SENDIG-DART v1.0 focuses on EFD, other study designs will be covered in future releases.