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FDA GUIDANCE: Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects Developed by: U-MIC University of Michigan IRB Collaborative

FDA guidance: Investigator responsibilities FDA guidance Guidance for Industry: Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects (October 2009)  drug/biologic trials  21 CFR 312  medical device trials  21 CFR Developed by: U-MIC Though specific responsibilities differ, general responsibilities are essentially the same.

FDA guidance: Investigator responsibilities Investigator responsibilities  supervising trial in which some tasks are delegated  employees  colleagues  third parties  ensuring trial is conducted according to  investigator statement (drugs/biologics)  Form FDA-1572  agreement (medical devices)  investigational plan  regulations  protecting subjects’  rights  safety  welfare  controlling investigational agents 4 Developed by: U-MIC

FDA guidance: Investigator responsibilities Investigator supervision  drug/biologic trials  Investigator personally conducts or supervises trial.  medical device trials  Investigator supervises all device testing that involves human subjects. 5 Developed by: U-MIC

FDA guidance: Investigator responsibilities Investigator supervision  delegating  employees  colleagues  third parties  not in investigator’s employ FDA assesses supervision, focusing on  delegates’ qualifications  delegates’ training and understanding of trial  investigator’s supervision and involvement in trial conduct  supervision and oversight of third parties 6 Developed by: U-MIC

FDA guidance: Investigator responsibilities Protecting subjects  appropriate medical care for study-related problems  Investigator may administer treatment.  Another practitioner may administer treatment.  access to medical care  availability of care throughout trial  particularly important with drugs with high toxicity and abuse potential  fatal toxicity potential: 24-hour contact  adherence to study protocol  Deviations may jeopardize subjects’ rights, safety, and welfare.  Comply closely with protocol to avoid unreasonable risks. 7 Developed by: U-MIC

FDA guidance: Investigator responsibilities IRB members  verify that investigators meet responsibilities  eResearch application  Section 1: General Information  Section 5: Research Design  Section 11: Confidentiality/Security/Privacy  Section 15: Drugs, Biologics, Etc.  Section 16: Devices  Section 32: Data and Safety Monitoring Plan  informed consent document 8 Developed by: U-MIC

FDA guidance: Investigator responsibilities 9 Developed by: U-MIC FDA Guidance Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects

THANK YOU. Brian Seabolt IRBMED 10 Developed by: U-MIC