This Public Review is intended to solicit feedback on the draft of version 1.0 of the SENDIG-Animal Rule.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.
CDISC relies on your input to ensure neutral, consensus-based data standards are developed and adopted by a diverse global community interested in improving research processes and quality for the benefit of all.
View the draft: SENDIG-Animal Rule v1.0.
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