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Clinical Data Management
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51	EGA contribution to the CMDh meeting with interested parties on DCP improvement London, 18 May 2015 EGA ANNUAL SURVEY ON THE DCP Add to Reading List Source URL: www.hma.eu Language: English - Date: 2015-05-29 10:17:04 Clinical data management Clinical research Pharmaceutical industry Quality Validation Validity
52	EU Module 1 eCTD Specification Version 3.0 October 2015 Document Control Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2016-08-19 03:15:42 Medical research Clinical research Clinical data management Health Computing Pharmaceuticals policy Electronic common technical document Markup languages Common Technical Document Marketing authorization Pharmacovigilance Document type definition
53	EMAAnnex 3. January 2015 Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2016-08-19 03:15:59 Computing Software Archive formats Clinical data management Clinical research Electronic common technical document Computer file formats Filename Zip Ar Naming convention Form
54	Syntax for Science SL \| ParcBit, Edif. NAORTE A Ctra. Valldemossa Km. 7.4 \| 07121, Palma de Mallorca – Spain t + \| \| www.syntaxforscience.com TABLE OF CONTENTS 1. Add to Reading List Source URL: www.syntaxforscience.com Language: English - Date: 2016-03-15 08:37:02 Clinical research Clinical data management Case report form User interface techniques Password EDIF Form Computing Software Research
55	Clinithink CLiX ENRICH Increase the potency of analytics solutions using unstructured data Healthcare technology platforms have a wealth of clinical Add to Reading List Source URL: clinithink.com Language: English - Date: 2015-05-19 11:06:24 Business intelligence Information technology Computing Information Formal sciences Big data Data Information technology management Unstructured data Analytics CLIX International Statistical Classification of Diseases and Related Health Problems
56	EU Module 1 Specification VersionNovember 2011 Document Control Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2016-08-19 03:15:45 Computing Medical research Clinical research Clinical data management Data Markup languages Electronic common technical document Open formats Common Technical Document Marketing authorization Portable Document Format OPML
57	Data Integrity and Compliance With CGMP Guidance for Industry DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Add to Reading List Source URL: www.fda.gov Language: English Pharmaceutical industry Pharmacology Pharmaceutical sciences Economy Pharmaceuticals policy Clinical data management Code of Federal Regulations Food and Drug Administration Title 21 CFR Part 11 Good manufacturing practice Validation Title 21 of the Code of Federal Regulations
58	Gateway user guide xml delivery files Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2016-08-19 03:15:47 Medical research Pharmaceutical industry Health Clinical data management Health informatics Clinical research Electronic common technical document Pharmaceuticals policy Marketing authorization
59	Submissions to the PSUR Repository using EMA Gateway/Web Client Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2016-08-19 03:16:01 Computing Health Clinical data management Clinical research Data Electronic common technical document Markup languages Computer file formats European Medicines Agency
60	Implementation guide for EU eCTD M1 specification Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2016-08-19 03:16:07 Clinical data management Clinical research Universal identifiers Identifiers Quality Health Evaluation Value Electronic common technical document Universally unique identifier Validation Globally unique identifier

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