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Common Data Format
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121	Guidance for Industry Submitting Marketing Applications According to the ICH-CTD Format — General Considerations DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Add to Reading List Source URL: www.fda.gov Language: English Food and Drug Administration Pharmaceutical industry Clinical Data Management Drug safety Common Technical Document New Drug Application International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Drug Master File Center for Biologics Evaluation and Research Clinical research Research Medicine
122	Draft Guidance Document - Preparatin of Drug Regulatory Activities in the Electronic Common Technical Document Format Add to Reading List Source URL: www.hc-sc.gc.ca Language: English - Date: 2013-07-09 17:16:48 Technology Clinical Data Management Pharmaceutical industry Pharmaceuticals policy Drug safety Electronic Common Technical Document Common Technical Document International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Drug Master File Medicine Clinical research Research
123	ISSUE ANALYSIS SUMMARY Guidance for Industry: Preparation of Drug Submissions in Electronic Common Technical Document (eCTD) Format Published by authority of the Minister of Health Add to Reading List Source URL: www.hc-sc.gc.ca Language: English - Date: 2013-07-12 14:25:49 Medicine Medical informatics Electronic Common Technical Document Food and Drug Administration Common Technical Document Health Canada Portable Document Format Clinical trial Regulated Product Submissions Clinical research Research Clinical Data Management
124	eCTD Validation Update Jared Lantzy Electronic Submission Support Team Office of Business Informatics, CDER DIA Electronic Document Management 2011 February 16, 2011 Add to Reading List Source URL: www.fda.gov Language: English Computer file formats Open formats Clinical Data Management Medical informatics Electronic Common Technical Document XML Validation Portable Document Format Food and Drug Administration Computing Clinical research Research
125	Microsoft PowerPoint[removed]Seggel.ppt Add to Reading List Source URL: www.fda.gov Language: English Medical informatics Research Electronic Common Technical Document Open formats Computer file formats Portable Document Format Hyperlink Computing Clinical Data Management Clinical research
126	Common Data Format Update Add to Reading List Source URL: csrc.nist.gov Language: English - Date: 2013-03-01 12:09:16 Government Electronic voting Information society Voluntary Voting System Guidelines IEEE Standards Association Federal Voting Assistance Program National Institute of Standards and Technology Voting machine Interoperability Election technology Standards organizations Politics
127	Notice - Electronic Specifications for Clinical Trial Applications and Amendments Add to Reading List Source URL: www.hc-sc.gc.ca Language: English - Date: 2013-06-24 11:52:37 Computing Electronic Common Technical Document Food and Drug Administration Pharmaceutical industry Common Technical Document Clinical trial Computer file Portable Document Format Clinical research Research Clinical Data Management
128	Notice: Release of Health Canada’s Revisions to“1.6 Electronic Review Documents” in Draft Guidance for Industry: Preparation of New Drug Submissions in the CTD Format. Add to Reading List Source URL: www.hc-sc.gc.ca Language: English - Date: 2013-07-12 14:25:53 Research Medical informatics Electronic documents Electronic Common Technical Document Digital media Common Technical Document Electronic submission Portable Document Format Submission management Clinical Data Management Clinical research Computing
129	The TGDC and the Common Data Format Professor Patrick McDaniel P1622 Workshop February 8, 2011 Systems and Internet Infrastructure Security Laboratory Add to Reading List Source URL: www.nist.gov Language: English - Date: 2011-02-28 14:27:05 Technical Guidelines Development Committee United States Department of Commerce Politics Voluntary Voting System Guidelines Government Common Data Format Software independence Certification of voting machines Election technology Electronic voting National Institute of Standards and Technology
130	Canadiana Metadata Repository Format (CMR) Version[removed]) Introduction Records ingested into the Canadiana Metadata Repository are mapped to a common standard: the Canadiana Metadata Repository (CMR) format. CM Add to Reading List Source URL: www.canadiana.ca Language: English - Date: 2010-11-22 13:08:30 Knowledge representation Technical communication Metadata Open formats ISO standards Dublin Core HTML Portable Document Format XML Information Data Computing

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