1. A risk-based approach to monitoring of clinical investigations questions and answers: guidance for industry Publication: Silver Spring, MD : Center for Drug Evaluation and Research, April 2023 Subject(s): Clinical Trials Data Monitoring CommitteesClinical Trials as TopicGovernment RegulationResearch DesignResearch PersonnelUnited States
2. Informed consent. Guidance for IRBs, clinical investigators, and sponsors Publication: Silver Spring, MD : Center for Drug Evaluation and Research, August 2023 Subject(s): Ethics Committees, ResearchGovernment RegulationInformed ConsentResearch PersonnelUnited StatesUnited States. Food and Drug Administration
