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Clinical Data
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#	Item
221	SHIP Privacy Impact Assessment A document of core programme 1 Background Scotland has very comprehensive health service data of high quality and consistency. However it is still rather disparate. A great deal of meaningf Add to Reading List Source URL: www.scot-ship.ac.uk Language: English - Date: 2014-04-01 08:15:46 Data protection Information privacy Privacy Medical privacy Statistical disclosure control UK Data Archive Internet privacy Data sharing Health informatics Data quality Clinical Practice Research Datalink
222	QuarterWatch Monitoring FDA MedWatch Reports Why Reports of Serious Adverse Drug Events Continue to Grow October 3, 2012 Data from 2012 Quarter 1 Add to Reading List Source URL: www.ismp.org Language: English - Date: 2012-10-03 12:53:27 Food and Drug Administration Clinical research Thiophenes Healthcare quality Medical terminology Adverse Event Reporting System Duloxetine Pharmacovigilance Rivaroxaban Adverse effect Adverse event MedWatch
223	Practical Guidance For the Paper Submission of Regulatory Information in Support of a Marketing Authorisation Application When Using an eCTD or a NeeS as the Source Submission. v2.0 Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2016-08-19 03:14:51 Clinical research Clinical data management Electronic common technical document Pharmaceutical industry Pharmaceuticals policy Common Technical Document Marketing authorization Electronic submission Drug Master File
224	DOC Document Add to Reading List Source URL: zoo.cs.yale.edu Language: English - Date: 2006-01-05 22:30:20 Health informatics Electronic health records Health Insurance Portability and Accountability Act Data protection Protected health information Medical privacy Next-Generation Secure Computing Base Privacy Medical record Information privacy Health Information Technology for Economic and Clinical Health Act National Provider Identifier
225	ANNEX 2 AF/02-007b/04 Document Receipt Form Protocol Number: Submitted date: Protocol Version Number: Add to Reading List Source URL: www.health.gov.bt Language: English - Date: 2016-06-29 07:05:05 Clinical research Pharmaceutical industry Clinical data management Medical ethics Case report form Clinical trial Informed consent Protocol Email Consent
226	European Medicines Agency Evaluation of Medicines for Human Use London, August 2009 EMEA V1.0 Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2016-08-19 03:14:52 Clinical research Clinical data management Pharmaceutical industry Electronic common technical document Pharmaceuticals policy Marketing authorization Probability distribution Validation
227	DOC Document Add to Reading List Source URL: www.ema.europa.eu Language: English - Date: 2016-07-20 07:22:57 Clinical research Pharmaceutical industry Clinical data management Drug safety Electronic common technical document Supplementary protection certificate European Medicines Agency Summary of Product Characteristics Pharmacovigilance Validation Drug Master File
228	Explanatory Note Monitoring Questionnaires tool This tool may assist local authorities signing the Pact of Islands to collect and store useful data from the main activity sectors during the ISEAP implementation period. T Add to Reading List Source URL: www.sustainableislands.eu Language: English - Date: 2015-06-08 12:28:44 Questionnaire Survey methodology Psychometrics Market research Usability Clinical data management Computer-assisted web interviewing
229	18 March 2015 EMAProcedure Management and Business Support Division Use of XML delivery file for submissions via eSubmission Gateway / Web Client – phased implementation for all Add to Reading List Source URL: esubmission.ema.europa.eu Language: English - Date: 2016-08-19 03:16:00 Clinical data management Clinical research Electronic common technical document Digital media Research Electronic submission Form European Medicines Agency
230	CLiX ENRICH White Paper The Application of CNLP (Clinical Natural Language Processing) for Improved Analytics Add to Reading List Source URL: clinithink.com Language: English - Date: 2015-05-19 11:05:49 Clinical research Standards organizations CLiX Unstructured data SNOMED CT Health informatics Clinical trial Health Level 7 Business intelligence Database

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