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.
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