Standardization for Exchange of Nonclinical Data (SEND)

1. American College of Toxicology Webinar, Co-sponsored by STP (September 2013)
• Preparing for Nonclinical eData Regulatory Submissions to the US FDA—“SEND” and Beyond

  Shree Nath, PhD, Vice President, PointCross Life Sciences
  Timothy J. Kropp, PhD, Team Leader, Tools Technology and Innovation Team, US Food and Drug Administration

2. STP/CL Davis DC Regional Meeting (November 2012)
• SEND Initiative

  Timothy Kropp, PhD, Toxicologist, Office of Translational Sciences, US FDA, Silver Spring, MD

• INHAND Collaboration with FDA on SEND

  Charlotte Keenan, VMD, DACVP, Fellow IATP, C.M. Keenan ToxPath Consulting, Doylestown, PA

• Requirements for Standardized Study Data: Update on Guidance (Search your browser for the title “FDA Standards Strategy: Where are We and Where are We Going” or locate under CSS Presentations & Posters at the CSS/phuse website.
  
  

  Ron Fitzmartin, PhD, Office of Strategic Programs, CDER, FDA

• The Changing Landscape for Nonclinical Data (Search title using your web browser)
  
  

  Timothy Kropp PhD, Toxicologist, CDER, US FDA

• International Harmonization of Nomenclature and Diagnostic (INHAND)
  • Guides for International Harmonization of Nomenclature and Diagnostic Criteria for Lesions in Rats and Mice
• Clinical Data Interchange Standards Consortium (CDISC)
  • This site includes: CDISC Standard for Exchange of Nonclinical Data Implementation Guide: Nonclinical Studies, Standard for Exchange of Nonclinical Data, CDISC SEND Controlled Terminology, SEND Implementation Guide and other resources.
• SEND Implementation Wiki
  This is the website with information on the fundamentals of SEND, getting SEND-ready, known issues and FAQs.

Send questions regarding submissions of electronic standardized data to edata@fda.hhs.gov.

• US FDA/PhUSE Computational Science Symposium (CSS)
  An annual working conference held by the US FDA and Pharmaceutical Users Software Exchange (phUSE) for discussing key issues in the industry.
• Study Data Standards Resources
  This US FDA webpage provides links to study data standards in current use and under development.
• Submission of Data in CDISC Format to CBER
  This US FDA webpage that explains the process of planning and accepting CDISC formatted submissions along with a list of resources.
• Test submissions for validation
  US FDA resource page for submitting a sample of standardized data.