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Clinical Data Interchange Standards Consortium
Results: 435

#	Item
371	CDER Data Standards Plan Version 1.1 Office of Planning and Informatics FDA/CDER December 15, 2010 Add to Reading List Source URL: www.fda.gov Language: English Medicine Health Pharmaceutical industry Medical informatics Pharmacology Investigational New Drug Clinical Data Interchange Standards Consortium Structured Product Labeling Clinical investigator Food and Drug Administration Research Clinical research
372	CDER Update eCTD & Gateway Submissions Virginia Ventura Team Lead, Electronic Submission Support Office of Business Informatics Add to Reading List Source URL: www.fda.gov Language: English Clinical research Medicine Electronic Common Technical Document Clinical Data Interchange Standards Consortium Structured Product Labeling Common Technical Document Electronic submission Food and Drug Administration Clinical Data Management Medical informatics Research
373	Microsoft PowerPoint[removed]Gary Gensinger.ppt [Compatibility Mode] Add to Reading List Source URL: www.fda.gov Language: English Research Clinical research Food and Drug Administration Clinical Data Management Standards organizations Electronic Common Technical Document Clinical Data Interchange Standards Consortium Prescription Drug User Fee Act SDTM Medicine Health Medical informatics
374	Assessment of CDER DAta Standards Program Add to Reading List Source URL: www.fda.gov Language: English Food and Drug Administration Clinical research Pharmaceutical industry Medical informatics Pharmacology Clinical Data Interchange Standards Consortium Investigational New Drug Health Level 7 Center for Biologics Evaluation and Research Pharmaceutical sciences Medicine Health
375	CDER_Common_Data_Standards_Issues_Doc_version1.1_Dec_2011.docx Add to Reading List Source URL: www.fda.gov Language: English Clinical trials Research SDTM Pharmacology Clinical Data Management Clinical Data Interchange Standards Consortium Standard for Exchange of Non-clinical Data Data set MedDRA Statistics Food and Drug Administration Clinical research
376	TEMPLATE Study Data Standardization Plan (Checklist) (SDTM, ADaM and CDASH) Add to Reading List Source URL: www.fda.gov Language: English Statistics Research Clinical Data Interchange Standards Consortium Medicine Checklist Food and Drug Administration Clinical trials SDTM
377	EXAMPLE Study Data Standardization Plan (Checklist) (SDTM, ADaM and CDASH) Add to Reading List Source URL: www.fda.gov Language: English Clinical trials Food and Drug Administration SDTM Pharmacology Clinical Data Interchange Standards Consortium MedDRA Data set SAS Statistics Clinical research Research
378	Data Standards Strategy – Action Plan Version: 1.4 Document Date: May 30, 2014 Add to Reading List Source URL: www.fda.gov Language: English Clinical research Medical informatics Clinical Data Management Clinical Data Interchange Standards Consortium Center for Biologics Evaluation and Research Adverse Event Reporting System Electronic Common Technical Document Center for Drug Evaluation and Research Good Clinical Data Management Practice Food and Drug Administration Research Medicine
379	Data Standards Communication Plan Add to Reading List Source URL: www.fda.gov Language: English Research Pharmacology Medical informatics Pharmaceutical industry Center for Drug Evaluation and Research Clinical Data Interchange Standards Consortium Prescription Drug User Fee Act Drug development Food and Drug Administration Clinical research Pharmaceutical sciences
380	Data Standards Strategy – Action Plan Version: 1.1 Document Date: July 29, 2013 Add to Reading List Source URL: www.fda.gov Language: English Medicine Food and Drug Administration Medical informatics Clinical Data Management Pharmaceutical industry Clinical Data Interchange Standards Consortium Clinical investigator Center for Biologics Evaluation and Research Electronic Common Technical Document Pharmaceutical sciences Clinical research Research

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