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Medical Dictionary for Regulatory Activities
Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (Canada):
http://www.pre.ethics.gc.ca/english/policystatement/policystatement.cfm
World Medical Association Medical Ethics Manual:
http://www.wma.net/e/ethicsunit/resources.htm
E2A Clinical Safety Data Management: Clinical Definitions and Standards for Expedited Reporting
E2B Data Elements for Transmission of Individual Case Safety Reports
E3 Structure and Content of Clinical Study Reports
E6 Guideline for Good Clinical Practice
E7 Studies in Support of Special Populations: Geriatrics
E8 General Considerations for Clinical Trials
E11 Clinical Investigation of Medicinal Products in the Pediatric Population :
Canadian Association of Research Ethics Boards (CAREB):
http://www.careb-accer.ca/index.html
Health Canada:
http://www.hc-sc.gc.ca/index_e.html
Health Products and Food Branch:
http://www.hc-sc.gc.ca/ahc-asc/branch-dirgen/hpfb-dgpsa/index_e.html
Guidance for Records Related to Clinical Trials GUIDE-0068
http://www.hc-sc.gc.ca/dhp-mps/compli-conform/index_e.html
Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices (20 June 1990)
Directive 93/42/EEC European Union Medical Device Directive (MDD), 12 July 1993,
Directive 2001/20/EC on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use
Directive 2005/28/EC laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorization of the manufacturing or importation of such products
Original Contributor:
Bruce Steinert, Evanston Northwestern Healthcare Research Institute
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