CDER Data Standards Strategy

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Medicine Medical informatics Clinical Data Management Clinical trials Clinical Data Interchange Standards Consortium Electronic Common Technical Document Adverse Event Reporting System SDTM Center for Biologics Evaluation and Research Research Food and Drug Administration Clinical research		CDER Data Standards Strategy Add to Reading List Source URL: www.fda.gov Download Document from Source Website File Size: 227,09 KB Share Document on Facebook

	TIGes vet Q&A-update - Sept 2013 DocID: 1rsZK - View Document
	Updated 08 JulyRelease Notes for the EU eCTD Validation Criteria version 6.1 The currently valid version of the eCTD validation criteria is version 6.1 and it needs to be applied as of 1 July 2016 in combination w DocID: 1rlRj - View Document
	Release Notes for Harmonised Technical Guidance for eCTD Submissions in the EU v3.0 This document highlights the changes incorporated in version 3.0, in comparison with version 2.0, of the eCTD guidance document. For cle DocID: 1rj2G - View Document
	1 AugustElectronic Application Forms are now fully available for use For initial marketing authorisation (human and veterinary), variation and renewal applications DocID: 1riM4 - View Document
	Submissions to the PSUR Repository using EMA Gateway/Web Client DocID: 1rhRl - View Document