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Good Clinical Practice
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51	eTMF and Email Kathie Clark V.P., Product Management MHRA “Good Clinical Practice Guide” Only relevant correspondence that is necessary for reconstruction of key activities and decisions (for example, the Add to Reading List Source URL: www.wingspan.com Language: English - Date: 2016-04-07 11:38:35
52	Specifications on research on humans The federal office of public health1 (BAG) and the Swiss Ethic Commissions for clinical research2 provide a comprehensive overview of the legal basis of science on humans (in G,F,I). Add to Reading List Source URL: www.alcoholresearch.ch Language: English - Date: 2013-11-21 02:39:31 Medical research Health Clinical research Pharmaceutical industry Federal Department of Home Affairs Health in Switzerland Pharmaceuticals policy Swissmedic Medical guideline Clinical trial Gene therapy Good clinical practice
53	Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance ICH April 1996 Add to Reading List Source URL: www.fda.gov Language: English
54	R: Regulatory Compliance and Validation Issues A Guidance Document for the Use of R in Regulated Clinical Trial Environments December 15, 2014 Add to Reading List Source URL: www.r-project.org Language: English - Date: 2015-03-04 04:31:16 Pharmaceutical industry Validation R Title 21 CFR Part 11 Good laboratory practice Medical device Good manufacturing practice Clinical trial Business process management Software Electronic trial master file
55	Minimum Criteria for ICH E6 GCP Investigator Site Personnel Training (Excerpt from TransCelerate BioPharma Operating Principles) Scope The intent of this document is to define the Minimum Criteria for Good Clinical Pract Add to Reading List Source URL: www.transceleratebiopharmainc.com Language: English - Date: 2015-12-07 16:54:46 Medical research Clinical research Pharmaceutical industry Good clinical practice Adverse event Source document Public Responsibility in Medicine and Research Informed consent Inclusion and exclusion criteria Serious adverse event Human subject research Trial master file
56	We know you are busy… Your contribution as a busy investigator to clinical research is invaluable in bringing new medicines to the patients who need them. But participating in clinical trials brings with it extra admin Add to Reading List Source URL: www.investigatordatabank.org Language: English - Date: 2014-12-04 11:04:25 Medical research Clinical research Pharmaceutical industry Good clinical practice Clinical trial Investigator
57	Microsoft Word - Code of Ethics Add to Reading List Source URL: www.embs.org Language: English - Date: 2015-12-11 09:17:55 Clinical research Medical ethics Research ethics Good laboratory practice Organisation for Economic Co-operation and Development Human subject research Pharmaceutical industry
58	Official Journal of the European Union EN Add to Reading List Source URL: www.cellforcure.com Language: English - Date: 2013-05-23 03:56:30 Research Health European Medicines Agency Good Clinical Practice Directive Directive 2001/83/EC Clinical Trials Directive Medicinal product Medical Devices Directive Medical device Clinical research Pharmaceuticals policy Medicine
59	NATIONAL PROGRAMME Chapter 6 Agriculture Add to Reading List Source URL: www.translation-centre.am Language: English - Date: 2008-10-07 01:30:11 Health Technology Clinical research Food safety Product safety Prevention Directive 93/41/EEC Good Laboratory Practice Pharmaceuticals policy Packaging European Union directives
60	DATA DISCLOSURE SURVEY Final Report MeTA Philippines July 2010 Add to Reading List Source URL: www.medicinestransparency.org Language: English - Date: 2013-01-23 03:06:02 Pharmaceuticals policy Health Pharmacy Clinical research Food and Drug Administration Good manufacturing practice Generic drug Validation New Drug Application Pharmaceutical sciences Pharmaceutical industry Pharmacology

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