№ lp_1_2_69033
Institutional procedural manual defining governance, ethical foundations, regulatory compliance, and operational practices for the planning, conduct, oversight, and quality assurance of clinical research involving human subjects at an academic medical research center.
Organization: USF Health Morsani Clinical Research Center
Institution: USF Health Office of Clinical Research
Document type: Standard operating procedures
Subject area: Clinical research governance and Good Clinical Practice
Geographic location: Tampa, Florida, United States
Regulatory framework: ICH-GCP, federal regulations
Intended users: Clinical investigators and clinical research staff
Contact information: Office of Clinical Research, USF Health
Scope: Administrative, regulatory, project management, subject management, data management, and quality assurance procedures
Ethical foundations referenced: Nuremberg Code, Declaration of Helsinki, Belmont Report
Source type: Institutional policy and procedural manual
Price: 8 / 10 USD
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