The Clinical Data Interchange Standards Consortium (CDISC) has established a set of open data standards for the representation and exchange of standardized study data collected over the course of nonclinical and clinical studies. The CDISC Standard for Exchange of Nonclinical Data (SEND) can be used to represent and exchange nonclinical study data. Regulatory agencies like the FDA require all nonclinical study data submitted for IND or NDA submissions to be in CDISC SEND format. Sponsors must submit data in FDA-supported formats listed in the FDA Data Standards Catalog, which specifies the use of CDISC standards such as SDTM, SEND, ADaM, Define-XML, and Controlled Terminology.
The goal is to have a consistent format for submitting nonclinical study data to the FDA. The format offers increased data quality, accessibility, and predictability, allowing for more effective examination of nonclinical data. Submitting standardized data is a great help to regulatory reviewers, as it enables them to receive, process, review, and archive submissions more effectively. This, in turn, can increase the likelihood of a successful review at the first attempt, and ultimately speed up the process of getting your drug to market. The FDA has designed tools to work with datasets that conform to CDISC standards.
SEND is the format for eData submission of subject-level as-collected data for nonclinical studies as a tabulated data model. The SEND format includes a well-structured data format and defined terms to maintain consistency in data across all nonclinical studies. FDA has accepted CDISC SEND as a format for submitting eData for nonclinical studies. CDISC releases the SEND IG versions periodically (the latest is SEND IG v3.1, the draft of 3.2 is in the process). The CDISC SENDIG (SEND implementation guide) Version 3, 3.1, and 3.1.1 describes the standard for representing the study data for general toxicology and carcinogenicity studies, which have been put in place to ensure the quality and completeness of the submitted data.
The purpose of SEND Datasets is Machine-readable representation of Nonclinical data to facilitate review of the collected data using standard tools and reduce the effort and time required to prepare the submitted studies for the medical reviewers. Only individual data (or individual animal data) from a non-clinical investigation are covered by the SEND format specification. The SEND criteria only apply to Module 4 (non-clinical study reports) of the eCTD because individual data is typically provided as an appendix to the study report. The installation of SEND has no impact on CTD Modules 2.4 (non-clinical overview) and 2.6 (non-clinical summaries).
The Quality Control (QC) process for SEND datasets involves a series of checks and verifications to ensure that the data is accurate, complete, and consistent. The first step in this process is to check the metadata, which includes information about the study design, sample size, and data sources. This information is used to ensure that the data is relevant and appropriate for the intended use.
The FDA utilizes SEND files in its assessment of the safety and efficacy of new drugs, biologics, and medical devices. The SEND datasets, which are submitted in a standardized format, provide the FDA with in-depth information about nonclinical studies. By using the data contained in SEND files, the FDA can make well-informed decisions about the approval of new products, considering both their potential risks and benefits, and ensuring that they meet all necessary regulatory requirements.
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