OHRA Training & Educational Videos The Office of Human Research Affairs provides access to a number of different trainings and educational resources to educate investigators on the protection of human subjects in research. The videos listed below are for use by persons who have submitted or plan to submit their applications to the Einstein IRB and are in need of guidance about a particular topic OHRA Training & Educational Videos Title Description Notes General IRB related topics IRB 101 A brief overview of the Einstein IRB and application submission process Sep.2021 ClinicalTrials.gov Introduction to the ClinicalTrials.gov regulations and major bodies requiring submission rev. June 2021 IRB Tips and Tricks Some common barriers to IRB approval May 2021 iRIS v.11 Logging in and navigating through the IRB submission system Aug 2020 Research with Human Data & Specimens When is IRB review required? sIRB 101 An overview of the single IRB process Aug 2020 FDA-related topics Investigational Device Exception (IDE) Application Series IDE Applications Part 1: Foundational Basics FDA requirements, the IRB’s role, and post-approval requirements for non-significant risk devices March 2021 IDE Applications Part 2: Expanded Access Types of expanded access and qualifying criteria for device determinations March 2021 IDE Applications Part 3: Specialty Cases Software, combination products, and general wellness in the IDE space March 2021 Investigational New Drug Applications FDA requirements, preparing a submission, ongoing reprting requirements, and the IRB’s role March 2021 Educational Videos are also available on the Office of Human Research Protections (OHRP) website