The course provides the learner with fundamental knowledge of regulatory affairs in clinical research, including discussions of institutional review boards, investigator site files, regulatory matrixes, and statements of investigator. The module examines Regulatory’s part in informed consent, delegation of authority, and financial conflicts of interest.
Language Availability: English
Suggested Audiences: Clinical Research Coordinators (CRCs), Clinical Research Pharmacists, Contract Research Organizations (CROs), Faculty, Investigators, Regulatory Affairs Professionals, Research Administrators, Study Sites
Organizational Subscription Price: Included with the Summit: Clin Ops Foundations series, available for $675 per year/per site as a subscription add-on for government and non-profit organizations; $750 per year/per site as a subscription add-on for for-profit organizations
Independent Learner Price: $99.39 per person
