The CLARA new submission form’s HIPAA section has been updated to make it easier to describe specific protected health information (PHI) elements to be accessed/recorded/used in research. Instead of asking you to describe “PHI data elements,” the first question now asks you to describe “specific health information that will be used/recorded for the research.” We […]
Using CLARA
Report recommends assessing IRB inspection program; evaluate IRB effectiveness
OHRP and FDA should conduct risk assessments annually to ensure they are routinely inspecting enough IRBs, according to a newly released report from the federal General Accounting Office (GAO). The GAO was asked to review independent IRBs, the processes used to protect human subjects, and standards of IRB quality. The agency found that independent IRBs […]
Having trouble opening a PDF in CLARA?
Some documents uploaded as PDFs in CLARA can be difficult to open. If you have trouble accessing a PDF in CLARA, please try accessing the document using a different browser. We’ve checked with IT, and IT says that some browsers have internal settings that won’t open a PDF correctly.