By submitting a request, you are affirming that the study posted on Sona is based on a research protocol that has been approved by ... The IRB website has instructions and templates for consent forms.

Use the Exempt Self-Assessment to decide if your research qualifies for exemption. The results will help you determine which templates to use in preparing your protocol for IRB review. Note: The ...

In most cases, no protocol ... research organization, A data safety monitor (e.g., DSMB, DSMC) An internal monitoring process. Participant Withdrawal from Research--Guidance for Investigators When a ...

The guide contains directions, examples and sample text for filling out HRP-503, the protocol template. It correlates with the IRB template to be released in January 2016. It will be updated to ...

Real world data (RWD), which is data from actual patient treatments, provides valuable information on safety and effectiveness of innovative ...