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Clinical site
Results: 565

#	Item
531	Essential Regulatory Documents Guidance and Binder Tabs Purpose: To provide an organizational framework and guidance for filing paper versions of essential study documents (or referencing location of an electronically s Add to Reading List Source URL: nccam.nih.gov Language: English - Date: 2013-07-18 09:56:46 Medicine Pharmacology Food and Drug Administration Clinical trial Institutional review board Investigational New Drug Clinical site Clinical investigator Regulatory requirement Research Clinical research Health
532	Specifications for Preparing and Submitting Summary Level Clinical Site Data for CDER’s Inspection Planning Add to Reading List Source URL: www.fda.gov Language: English Science Food and Drug Administration Design of experiments Evaluation methods Pharmacology Electronic Common Technical Document Clinical trial Placebo-controlled study Investigational New Drug Research Clinical research Medicine
533	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
534	Tool Summary Sheet Tool: Regulatory Binder Checklist Purpose: To provide an organizational framework for filing paper versions of essential study documents (or referencing location of an electronically stored file) Add to Reading List Source URL: nccam.nih.gov Language: English - Date: 2014-05-14 13:34:25 Pharmaceutical sciences Pharmacology Science Institutional review board Clinical trial Clinical site Clinical investigator Regulatory requirement Good Clinical Practice Clinical research Research Pharmaceutical industry
535	Tool Summary Sheet Tool: Protocol Deviation Tracking Log Purpose: To record all protocol deviations that occur at a study site Add to Reading List Source URL: nccam.nih.gov Language: English - Date: 2013-07-18 09:56:48 Pharmacology Science Research Drug safety Institutional review board Deviation Communications protocol Protocol Clinical research Statistics Design of experiments
536	DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 Add to Reading List Source URL: www.fda.gov Language: English Science Medicine Food and Drug Administration Drug safety Design of experiments Institutional review board Investigational New Drug Clinical trial Clinical site Clinical research Research Pharmacology
537	Providing Submissions in Electronic Format -- Summary Level Clinical Site Data for CDER Add to Reading List Source URL: www.fda.gov Language: English Medicine Health Pharmaceutical industry Pharmacology Medical informatics Electronic Common Technical Document Clinical investigator New Drug Application Center for Drug Evaluation and Research Food and Drug Administration Research Clinical research
538	Tool Summary Sheet Tool: Investigational Product Accountability Log: Stock Record Purpose: To document all study product disposition and accountability on the site level Add to Reading List Source URL: nccam.nih.gov Language: English - Date: 2013-07-18 09:56:48 Pharmaceutical sciences Food and Drug Administration Pharmacology Pharmaceutical industry Clinical trial Design of experiments Pharmacy Clinical research Research Science
539	Audience Questions from Oct. 24 Guidance Webinar Oversight of Clinical Investigations -- A Risk-Based Approach to Monitoring Add to Reading List Source URL: www.fda.gov Language: English Pharmacology Pharmaceutical industry Food and Drug Administration United States Public Health Service Clinical site Monitoring in clinical trials Clinical trial Clinical research Pharmaceutical sciences Research
540	IMPORTANT LEGAL NOTICE - The information on this site is subject to a disclaimer and a copyright notice Add to Reading List Source URL: ec.europa.eu Language: English - Date: 2013-10-09 09:25:48 Research Health policy Directive 75/319/EEC Directive 65/65/EEC Directive 2001/83/EC Factortame litigation Supplementary protection certificate European Directive on Traditional Herbal Medicinal Products Pharmaceuticals policy Clinical research Law

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