Date and Time:
TUE, 5 MAR 2019, 10:00 AM - 11:30 AM Central US Standard Time | 4:00 PM - 5:30 PM (GMT London Time)
This webinar will introduce the SENDIG-Animal Rule to the CDISC community for Public Review. The SENDIG-Animal Rule v1.0 is based on the SDTM v1.8 and is intended to be used in conjunction with the SENDIG v3.1 for data being submitted to the US Food & Drug Administration (FDA) under the Animal Rule. The regulations commonly known as the Animal Rule (AR) provide a regulatory mechanism for the approval of drugs and licensure of biological products when human efficacy studies are not ethical or feasible.
Under the AR, efficacy is established based on adequate and well-controlled studies in animal models of the human disease or condition of interest, and safety is evaluated under the pre-existing requirements for drugs and biological products. Like other implementation guides based on the SDTM, the SENDIG-AR is intended to guide the organization, structure, and format of standard tabulation datasets. The webinar will also address changes in SDTM v1.8 that are relevant to the SENDIG-AR.
Public review is a key quality step in our Standards Development Process. CDISC relies on your input to ensure neutral, consensus-based standards are developed and adopted by a diverse global community interested in improving clinical research. We invite you to contribute your expertise.
- Fred Wood, VP, Consulting Services, Data Standards Consulting Group
Webinar Language: English
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