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Entering the Field of Clinical Trials
Evaluating a Sponsor
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activities administrative adverse events adverse experiences agency agent animal test appropriate approval assessment assure audit blood budget chapter clinical research clinical trials committee completed compliance conduct consent document costs criteria discussed disease disulfiram dose drug eligibility employees endoscopy enrollment decision entry ethical evaluation EXAMPLE facility follow-up furosemide Gastroscopy hospital hypertension identified informed consent process initial inspection institutional review board investigator's investigator's brochure involved issues laboratory listed medical monitor ment participation patient payment performance person personnel pharmaceutical physician PI's placebo population possible potential practice problems procedures protocol reaction recruitment referral regulations regulatory research chart research process research records research team responsibility risks routine safety schedule Scientific misconduct screening side effects specific sponsor staff member study medication submission Table telephone telescreening tient tion ulcer usually