Live CDER SBIA Webinar Today: Most Common Issues with CDISC-SEND Data in FDA Toxicology Review

Most Common Issues with CDISC-SEND Data in FDA Toxicology Review TODAY | Sep. 12, 2019 | 1:00 p.m. Eastern | FREE

FDA will discuss trends with the Clinical Data Interchange Standards Consortium - Standard for Exchange Nonclinical Data (CDISC-SEND) data quality issues in sponsor-submitted studies and how industry may resolve them. CDER’s Office of Computational Science (OCS) will present. OCS manages the KickStart Service which provides data quality assessments to pharmacology and toxicology reviewers in the Office of New Drugs (OND). The webinar will cover several examples of substantive data quality issues FDA sees across studies. For example, the Subject Element domain sometimes contains overlapping dates across elements.

Register Now

TOPICS Common data quality and data fitness issues Evaluate possible solutions to the data fitness issues presented and provide resources that may be helpful to industry FDA communication methods to provide feedback to sponsors about data quality issues Overview of the components of the KickStart Service related to data fitness and data exploration INTENDED AUDIENCE Regulatory affairs professionals who submit SEND data to FDA for review for: Investigational new drug applications (INDs) New drug applications (NDAs) Certain biologics license applications (BLAs) CROs and/or consultants preparing and reviewing SEND datasets for sponsors Staff of standards developing organizations responsible for implementation guides for use by the pharmaceutical industries