Standard for the Exchange of Non-Clinical Data (SEND) general framework and the role and significance of SEND

The Standard for the Exchange of Nonclinical Data (SEND) is an electronic data format standard for data submission for safety pharmacology, general pharmacology, reproductive toxicology and other related studies required by the US FDA. Its function is to standardize and modularize preclinical experimental data and supporting information, and make the data complete and logical. The emergence of SEND is the result of joint promotion by the FDA, multiple pharmaceutical companies, CRO and other institutions. Submitting data in the SEND format brings great convenience to all parties.

 

The SEND standard is defined and maintained by the SEND team of the Clinical Data Inter-change Standards Consortium (CDISC). At present, CDISC standards have been widely adopted by countries and regions such as Europe, the United States, and Japan, and are widely used in clinical and non-clinical research. The use of SEND was further clarified in the Providing Regulatory SubmissionsIn Electronic Format — Standardized Study Data issued by the FDA in 2014 (the regulation will be updated in 2020). According to the requirements of the FDA, from December 18, 2016, applications for general toxicity tests (including single and multiple doses) and carcinogenicity tests for NDA, ANDA and BLA must be submitted in the SEND format; and from December 18, 2017 From now on, general toxicity tests for IND applications must also use the SEND format. In addition, safety pharmacology experiments for NDA and BLA applications conducted after March 16, 2019, and safety pharmacology experiments for IND applications conducted after March 16, 2020, are also required to be submitted to the FDA authority in SEND format.

 

A common framework for the SEND standard

 

 

The Send standards describe standard methods for exchanging non-clinical research data. These standards provide a consistent and common framework for organizing research data, including the following:

Template for dataset

the fully qualified name of the variable

appropriate controlled terminology

Standard way to do calculations using public variables

 

The role of SEND

 

 

At present, the CDISC standard has been accepted by drug regulatory authorities in Europe, the United States, Japan and other countries, and is widely used in clinical research. It is committed to providing data standards for the development of medical and biopharmaceutical products. Non-clinical data can be reviewed more efficiently with the SEND format.

Therefore, with the SEND data set, both sponsors and FDA can quickly review data, thereby improving data quality, accessibility, and predictability.

How will SEND evolve over time?

SENDIGv3.1 is included in cardiovascular and respiratory safety pharmacology studies. Such non-clinical studies conducted from March 15, 2020, must submit SEND for all IND applications. For non-clinical developmental and reproductive toxicology (DART) studies starting from March 15, 2023, SEND submission will be mandatory for NDA applications. Such non-clinical studies carried out from March 15, 2024 will also need to submit SEND and implementation guideline SENDIG DARTv1.1 in all IND applications. We expect that in the coming years, more research types will be included in the scope of implementation.

What are the benefits of SEND?

SEND is a priority approach that addresses efficiency, quality and problem communication. Regulators no longer need to enter data, speeding up the review process, being able to use existing visualization tools to review standardized data sets, and facilitating analysis, visualization and comparison between studies, regardless of the client or research institution from which the data originat