CDISC® SEND stands for the Clinical Data Interchange Standards Consortium Standard for Exchange of Nonclinical Data. Under the current timeline, within the next two to three years, any company or organization collecting, exchanging and submitting nonclinical data to the FDA will be required to adhere to SEND guidelines and regulations.

SEND is defined in the SEND Implementation Guide (SENDIG) and is developed and maintained by the CDISC SEND Team. SEND supports single- and repeat-dose general toxicology as well as carcinogenicity studies. Safety pharmacology and reproductive toxicology are currently out of scope.

The SENDIG is based on the CDISC Study Data Tabulation Model (SDTM) for clinical data and is intended to guide the industry on the structure, organization and format of standard nonclinical tabulation datasets for exchange between organizations, such as sponsors and CROs, and for submission to the FDA.

SEND at Charles River

Charles River has been involved with the CDSIC SEND initiative since 2003. In 2007, a representative from Charles River joined the CDISC SEND team and was nominated as the SEND Findings Sub-Team Lead in 2008. Charles River remains deeply involved with piloting SEND datasets with our sponsors and the FDA. By being a part of the CDISC SEND team, we were profoundly involved with the development of the CDISC SEND Implementation Guide Version 3.0.

Charles River began the validation of the SEND Suite to produce SEND data in January 2013 for all studies conducted using our global data capture system. We are expecting the validation to be completed by Q4 of 2013. SEND will be produced for single dose, repeat-dose and carcinogenicity studies as per the SEND Implementation Guide. 

We have been piloting SEND data with our sponsors throughout the course of the validation in order to test the datasets and processes.

When Will SEND 3.0 Become Mandatory?

The fifth renewal of the Prescription Drug User Fee Act (PDUFA V) was signed by President Barack Obama on July 10, 2012 and became effective on October 1st, 2012.

The FDA Draft Guidance for Industry entitled Providing Regulatory Submissions in Electronic Format — Standardized Study Data was expected to be finalized by October 1st, 2012. Due to overwhelming comments/concerns by the industry, the FDA has rewritten the guidance and expects to re-issue it for another public comment review period shortly. The guide is now expected to be finalized by the end of 2013 or beginning of 2014.

Once these two documents are finalized (expected for January 1st, 2014), the clock will start ticking for SEND as follows:

  • Twelve (12) months after publication of the final guidance and PDUFA V: All industry is expected to start collecting their data to be SEND-compliant.
  • Twenty-four (24) months after publication of the final guidance and PDUFA V: SEND will be required for all new original NDA and BLA submissions, all new NDA and BLA efficacy supplements and amendments, all new NDA and BLA labeling supplements and amendments, all new manufacturing supplements and amendments, and all other new NDA submissions.
  • Thirty-six (36) months after publication of the final guidance and PDUFA V: SEND will be required for all original commercial INDs and amendments, except for submissions described in section 561 of the Federal Food, Drug, and Cosmetic Act.

The FDA shall periodically publish final guidance specifying the completed data standards, formats and terminologies that sponsors must use to submit data in applications. In the case of standards for study data, new data standards and terminology shall be applicable prospectively and only required for studies that begin 12 months after the issuance of the FDA's final guidance on the applicable data standards and terminology.

For more detailed information about Charles River and the SEND initiative, contact us at askcharlesriver@crl.com.