This CDISC Public Webinar will introduce the SENDIG-Animal Rule to the CDISC community for Public Review.
The SENDIG-AR is based on the SDTM, and is intended to be used in conjunction with the SENDIG 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 preexisting 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.
Public review is a key quality step in the development of a thorough SENDIG for the research community. We invite you to contribute your expertise.
- Fred Wood, Vice President Consulting Services, Data Standards Consulting Group