This session will provide an overview of the Response Plan for Emergencies Impacting Penn’s Human Research Protections Program (Penn IRB SOP GA 108) to ensure the rights and welfare of research participants during an emergency. This session will also review the Emergency Risk Mitigation Planning Guidance providing investigators with guidance for developing protocol-specific plans to […]
If you are new to the IRB or want to take a deep dive into the informed consent process, please attend our Informed Consent 101 Training Session. IRB staff will cover definitions of informed consent, types of consent, required elements of consent, waivers of consent, and more. This session will be relevant to all schools […]
If you are new to the IRB and in need of some guidance, please attend one of our IRB 101 Training Sessions. IRB staff will cover the basic types of submissions including initial applications, continuing review, modifications, deviations, and reportable events. Staff will also provide brief information about the upcoming new submission system, HRAP. However, […]
If you are new to the IRB and in need of some guidance, please attend one of our IRB 101 Training Sessions. IRB staff will cover the basic types of submissions including initial applications, continuing review, modifications, deviations, and reportable events. Staff will also provide brief information about the upcoming new submission system, HRAP. However, IRB 101 will […]
If you’re designing a study with a drug or device (e.g., lab test, software application, or other device product) – do you know if you need an Investigational New Drug (IND) or an Investigational Device Exemption (IDE) Application? Can your study be exempt from the IND or IDE regulations? Attend our Regulatory Requirements for Investigator […]