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SDTM
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#	Item
311	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
312	2012 Data Standards Program Annual Assessment Add to Reading List Source URL: www.fda.gov Language: English Health Medicine Clinical Data Management Standards organizations Food and Drug Administration Clinical Data Interchange Standards Consortium Electronic Common Technical Document Health Level 7 SDTM Research Medical informatics Clinical research
313	# Project Name and Description E-platform: a common electronic platform for the exchange of clinical research data (i.e., the data normally collected during the course of a clinical trial, as well as the submission, rec Add to Reading List Source URL: www.fda.gov Language: English Medical informatics Research Clinical research Clinical Data Management Standards organizations Clinical Data Interchange Standards Consortium Health Level 7 Prescription Drug User Fee Act SDTM Medicine Health Food and Drug Administration
314	CDISC SEND Controlled Terminology, [removed]Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/cancerlibrary/terminologyresources/cdisc NCI Code CDISC Submission Add to Reading List Source URL: evs.nci.nih.gov Language: English - Date: 2014-06-26 12:18:04 Science Standards organizations Clinical Data Interchange Standards Consortium Clinical Data Management Clinical research Nonprofit technology Test method SDTM Statistics Measurement Medical informatics
315	CDISC SDTM Controlled Terminology, [removed]Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/cancerlibrary/terminologyresources/cdisc NCI Code CDISC Submission Add to Reading List Source URL: evs.nci.nih.gov Language: English - Date: 2014-06-26 12:16:01 Food and Drug Administration Clinical research Medical emergencies Aging-associated diseases Clinical trials SDTM Clinical Data Interchange Standards Consortium Myocardial infarction Acute coronary syndrome Medicine Health Research
316	CDISC CDASH Controlled Terminology, [removed]Source: NCI EVS Terminology Resources website: http://www.cancer.gov/cancertopics/cancerlibrary/terminologyresources/cdisc NCI Code CDISC Submission Add to Reading List Source URL: evs.nci.nih.gov Language: English - Date: 2014-03-28 10:34:24 Medicine Clinical trials Food and Drug Administration SDTM Dosage forms Clinical Data Interchange Standards Consortium Dose Pharmacology Clinical research Research
317	Understanding, Analyzing, and Presenting Your YRBS Data The Youth Risk Behavior Survey (YRBS) results in your report binder will be of great interest to many people in your state or district. Students, parents, school ad Add to Reading List Source URL: www.healthyschoolsms.org Language: English - Date: 2009-12-08 12:34:36 Market research Measurement Econometrics Research methods Confidence interval Response rate Survey methodology Margin of error SDTM Statistics Science Sampling
318	PDF Document Add to Reading List Source URL: www.fda.gov Language: English Science Scientific method Design of experiments Food and Drug Administration Evaluation methods Clinical trial Institutional review board SDTM Crossover study Research Clinical research Pharmacology
319	Previous Version of Draft eSource Guidance Add to Reading List Source URL: www.fda.gov Language: English Research Pharmaceutical sciences Case report form Center for Biologics Evaluation and Research Clinical site SDTM Clinical research Clinical Data Management Food and Drug Administration
320	Contains Nonbinding Recommendations Add to Reading List Source URL: www.fda.gov Language: English Computer file formats Medical informatics Clinical Data Management Food and Drug Administration Clinical Data Interchange Standards Consortium SDTM Portable Document Format Clinical trial Document file format Research Clinical research Science

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