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Serious adverse event
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#	Item
221	Microsoft Word - Pre-Submission Checklist one pager DRAFT _05-11-11_ update links Add to Reading List Source URL: prsinfo.clinicaltrials.gov Language: English - Date: 2014-03-11 16:44:01 Adverse event Serious adverse event Science Scientific method Clinical research Pharmaceutical industry Research
222	More details available in the “Basic Results” Data Element Definitions. Sept 11, 2012 ClinicalTrials.gov Add to Reading List Source URL: prsinfo.clinicaltrials.gov Language: English - Date: 2014-03-11 16:44:01 Serious adverse event Adverse event Medicine Clinical research Pharmaceutical industry Research
223	Example Data and Safety Monitoring Plan (DSMP) Independent Monitor NOTE: This sample template is solely for guidance purposes and does not constitute National Center for Complementary and Alternative Medicine (NCCAM) pol Add to Reading List Source URL: nccam.nih.gov Language: English - Date: 2012-05-17 12:18:45 Research Health Clinical trial Adverse event National Center for Complementary and Alternative Medicine Patient safety Patient recruitment Alternative medicine Serious adverse event Clinical research Pharmaceutical industry Medicine
224	Adverse Event Form STUDY NAME Site Name:___________________________ Pt_ID:_________________________ This form is cumulative and captures adverse events of a single participant throughout the study. Add to Reading List Source URL: nccam.nih.gov Language: English - Date: 2014-01-15 16:55:53 Serious adverse event Adverse event Clinical research Pharmaceutical industry Research
225	Serious Adverse Event (SAE) Report Form STUDY NAME Protocol Number: Add to Reading List Source URL: nccam.nih.gov Language: English - Date: 2014-01-20 17:10:56 Clinical research Pharmaceutical industry Serious adverse event
226	Post Approval Safety Data Management Add to Reading List Source URL: www.fda.gov Language: English Health Pharmaceutical industry Clinical research Drug safety Pharmacy Pharmacovigilance Adverse effect Adverse event Serious adverse event Pharmacology Pharmaceutical sciences Medicine
227	Guideline for Industry Clinical Safety Data Management: Definitions and Standards for Expedited Reporting Add to Reading List Source URL: www.fda.gov Language: English Clinical research Health Drug safety Pharmaceutical industry Pharmacy Serious adverse event Pharmacovigilance Adverse event Adverse effect Pharmacology Pharmaceutical sciences Medicine
228	Reviewer Guidance Conducting a Clinical Safety Review of a New Product Application and Preparing a Report on the Review U.S. Department of Health and Human Services Add to Reading List Source URL: www.fda.gov Language: English Health Clinical research Pharmaceutical industry Food and Drug Administration Drug safety Adverse effect Serious adverse event Clinical trial Adverse event Pharmacology Pharmaceutical sciences Medicine
229	Overview of comments received on Volume 9B Revision October 2009 of The Rules Governing Medicinal Products in the European Union - Guidelines on Pharmacovigilance for Medicinal Products for Veterinary Use - Interested p Add to Reading List Source URL: ec.europa.eu Language: English - Date: 2013-10-09 08:59:09 Health Clinical research Pharmaceutical industry Drug safety Pharmacy Pharmacovigilance Adverse event Adverse effect Serious adverse event Pharmacology Pharmaceutical sciences Medicine
230	EUROPEAN COMMISSION DIRECTORATE GENERAL for HEALTH and CONSUMERS Consumer Affairs Cosmetics and Medical Devices MEDDEV 2.7/3 Add to Reading List Source URL: ec.europa.eu Language: English - Date: 2013-10-03 11:49:08 Technology Research Medical equipment European Union directives Medical device Medical technology Adverse event Serious adverse event Medical Devices Directive Clinical research Medicine Pharmaceutical industry

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