2. 1 Developed by: U-MIC To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you press enter.

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

4. 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 812 3 Developed by: U-MIC Though specific responsibilities differ, general responsibilities are essentially the same.

5. 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

6. 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

7. 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

8. 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

9. 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

10. FDA guidance: Investigator responsibilities 9 Developed by: U-MIC FDA Guidance Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects http://www.fda.gov/downloads/Drugs/.../Guidances/UCM187772.pdf

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