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331	Op#mizing the Use of Data Standards Working Group Overview and Projects Summary Working Group Overview Op#mizing the Use of Data Add to Reading List Source URL: www.phusewiki.org Language: English - Date: 2013-05-29 09:36:06 Clinical Data Management Standards organizations Clinical trials Clinical Data Interchange Standards Consortium Nonprofit technology SDTM Traceability Food and Drug Administration Biogen Idec Clinical research Research Technology
332	Improving Data Quality Working Group Update March 18-‐19, 2013 2012 Projects •  Develop Guidelines for ValidaHon Rule Add to Reading List Source URL: www.phusewiki.org Language: English - Date: 2013-05-29 09:35:53 Clinical research Medical informatics Standards organizations Clinical Data Interchange Standards Consortium Clinical Data Management SDTM Center for Biologics Evaluation and Research Health Level 7 Medicine Health Food and Drug Administration
333	Relating PC and PP Domains using RELREC Records Dr. Peter Schaefer, Director Product Management, Certara™ [removed] The pharmacokinetics domains for pharmacokinetic concentrations and the resulting pha Add to Reading List Source URL: www.phusewiki.org Language: English - Date: 2013-05-29 10:31:23 Clinical research Pharmacology Pharmacokinetics Domain Parameter Food and Drug Administration SDTM Pharmaceutical sciences
334	Making Progress: The FDA/PhUSE Collabora:on and Computa:onal Science Symposium Part II Add to Reading List Source URL: www.phusewiki.org Language: English - Date: 2013-05-29 09:35:42 Health Center for Drug Evaluation and Research Poster session Poster Quality by Design SDTM Food and Drug Administration Clinical research Pharmaceutical sciences
335	Moving to SAS Drug Development 4 Magnus Mengelbier Director 1 Add to Reading List Source URL: www.phusewiki.org Language: English - Date: 2014-06-16 06:36:51 Business intelligence SAS Clinical Data Interchange Standards Consortium SDTM R Statistics Software 4GL
336	Using OpenCDISC in an Outsourced Model Paul Bukowiec Steve Wong PhUSE Boston[removed] Add to Reading List Source URL: www.phusewiki.org Language: English - Date: 2014-05-13 06:52:40 Food and Drug Administration SDTM Regression analysis Type theory Clinical Data Interchange Standards Consortium Dependent and independent variables Statistics Mathematics Variables
337	ataset D CDISC StudyDataSet-XML Leaving the Stone Age of data transmission PhUSE SDE Copenhagen, 11th June 2014 Add to Reading List Source URL: www.phusewiki.org Language: English - Date: 2014-06-16 06:37:04 Medical informatics Clinical Data Interchange Standards Consortium Clinical Data Management Clinical research Nonprofit technology SDTM XML Computing OSI protocols Statistics
338	PhUSE Boston Single Day Event OpenCDISC: Checks, Are They Useful, How to Interpret, Do All Need to be Fixed and How to Document May 7th 2014 Majdoub Haloui Add to Reading List Source URL: www.phusewiki.org Language: English - Date: 2014-05-13 06:52:39 Clinical trials Food and Drug Administration Clinical Data Interchange Standards Consortium Clinical Data Management SDTM Validator Validation Clinical research Research Statistics
339	A “How-to Guide” for Trial Summary[removed]Nicola Tambascia & Anita Eisberg Accovion GmbH PhUSE SDE Frankfurt 2014 Add to Reading List Source URL: www.phusewiki.org Language: English - Date: 2014-05-20 08:47:47 Research SDTM Medical informatics Measurement Clinical Data Management Standards organizations Clinical Data Interchange Standards Consortium SNOMED CT Frankfurt Clinical trials Statistics Food and Drug Administration
340	Challenges with the interpreta/on of CDISC -‐ Add to Reading List Source URL: www.phusewiki.org Language: English - Date: 2014-06-16 06:36:47 Clinical Data Management Statistics SDTM Clinical research Clinical Data Interchange Standards Consortium Measurement Clinical trials Research Food and Drug Administration

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