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Challenges of Submitting Electronic Study Data to Two Authorities: the PMDA & FDA.Lessons Learned for Successful e-Study Data Submission to the PMDA toward the End of Transitional Period.Electronic Data Submission to PMDA : Our experiences and matters of concern.Industry Experience with PMDA Data Submissions CDISC標準準拠データの提出の現状と (Current status of submission of CDISC standard compliant data).Electronic Data Submission and Utilization in Japan.Study Data Validation Rules Version 2.0 ().Study Data Validation Rules Version 1.0 ().Technical Conformance Guide (English version, January 2019).
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Industry Experience with FDA Data Submissions The Evolution of FDA Regulatory Submissions in the PDUFA Era.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.
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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.