![]() ![]() Using CDISC-SEND Standardized Data in FDA Toxicology Review: The KickStart Service.Impact of SEND Data on FDA Review of Nonclinical Studies.Developing SEND for CBER - Collaborative Workstream Initiative.FDA View: Update on Study Data Submission.Bioresearch Monitoring Technical Conformance Guide v2.0 (July 2020).FDA Data Standards Catalog v7.0 (March 15, 2021). ![]() Study Data Technical Conformance Guide v.Technical Rejection Criteria for Study Data.Known Issues in PMDA Validation Engine 1810.3įDA Data Submissions FDA Guidance Documentations. ![]() The following is a collection of documents, publications, and articles related to Pinnacle 21 Community, data validation and quality assessment, CDISC standards, and regulatory agencies. ![]()
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