The Post Approval Monitoring (PAM) team within Research Regulatory Affairs aims to help ensure the well-being of humans and vertebrate animals involved in research. Authorization for researchers to ...

Electronic informed consent (eConsent) tools are emerging as a valuable solution in the quest to deliver a more patient-centric clinical trial experience. eConsent platforms take the complex paper ...

Federal Regulations [45 CFR 46.103(b)(5) and 21 CFR 56.108(b)(1)] and UAB IRB policy (POL006) requires Principal Investigators of all human subject’s research (FDA-regulated or not), and their ...

The Initial Protocol Application, like all of the HRPP webforms, is an interactive form with built-in logic. That means that the answers to some questions will reveal other questions. Only the ...

Download the template(s) of your choice. The template documents open as Word files; save as a Word file to begin drafting your protocol. All instructions in the template are highlighted in blue.

The flowchart and steps below outlines the best practice for processing industry-written and sponsored clinical trials at UAB. There are many small steps in each of the larger defined steps (see flow ...

Research studies may result in the implementation of unapproved changes to IRB-approved research plans or failure to comply with established regulations, policies, and procedures. Any action or ...

If it’s possible a project will fall under the category of “research involving human subjects,” a great deal of preliminary planning will be required. It’s never too early to learn about the ethical ...

Follow the step-by-step instructions below to successfully prepare and submit a protocol to the IRB. Instructions below include information about single IRBs, student involvement in human subject ...

Follow the step-by-step instructions below to successfully maintain and close a protocol with the IRB. Instructions below include information about continuing reviews, amendments, event reporting (new ...