SEND Implementation Guide for DART Issued by CDISC
Study Design Coverage Expanding
CONSHOHOCKEN, PA - August 16, 2016 - The CDISC/SEND Leadership Team has announced the publication of the CDISC SEND Implementation Guide: Developmental and Reproductive Toxicology (DART) Version 1.0 (Provisional).
The SENDIG-DART is based on and should be used in conjunction with the SENDIG v3.1. This extends the SEND standard into Reproductive Toxicology by supporting study data typically found in embryo-fetal development (EFD) toxicity studies and introduces new concepts, such as study phase days based on reproductive events. Additional study designs (e.g., Fertility, Postnatal Development - Multi-generational) will be covered in future releases.
SENDIG-DART v1.0 is provisional because it introduces new variables that are not yet in a published version of the overall model, SDTM. The final publication will depend upon a future SDTM model release.
In addition, remember that the timing of adoption by the FDA is a process separate from standards development. The FDA site to watch for standards adoption for submissions is: http://www.fda.gov/forindustry/datastandards/studydatastandards/default.htm
This is the second SEND Team release in recent weeks but represents many years of effort by the SEND Repro sub team.
Refer to the CDISC announcement www.cdisc.org/send for access to the document. As always, we’re here to help with any questions you may have about the standard.
Instem will shortly make available, upon request, a pre-recorded presentation that will provide an explanation of the changes to the standard, along with guidance on implementation considerations. Look for more information coming soon.
Instem developed submit, the first commercially available SEND software solution in 2005 and its comprehensive set of tools are now the most widely adopted in the market, supporting over 45 client sites across 15 countries. The submit platform is meeting the very wide range of demands that span the needs of the largest multi-national pharmaceutical organizations and CROs to the smallest organizations and their advisors.
During this period of preparation and especially following FDA’s long awaited final guidance (December 18, 2014) for standardized study data for providing submissions in electronic format, the demand for outsourced SEND services has rapidly grown. Now across every stage of SEND-Readiness, clients can choose from one or more Instem solution-services that will help them in their journey towards SEND compliance, while minimizing the impact within their organization. This includes the option for organizations to completely turn to Instem as their fully-outsourced SEND department.
More information about how organizations can Submit™ with confidence can be found here.
Instem is a leading supplier of IT applications and services to the early development healthcare market delivering compelling solutions for data collection, analysis and regulatory submissions management. Instem solutions are in use by customers worldwide, meeting the rapidly expanding needs of life science and healthcare organizations for data-driven decision making leading to safer, more effective products.
Instem’s portfolio of software solutions and consulting services increases client productivity by enhancing product development processes while offering the unique ability to generate new knowledge through the extraction and harmonization of actionable scientific information.
Instem supports over 500 clients through offices in the United States, United Kingdom, Japan, China and India.
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Julie Jones (UK HQ)
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