When reviewing a proposed modification, remember that reviewers can (and should!) ask for summaries of complicated submissions and/or a description of what the modification means for the study. These items are sometimes within the revised document itself, e.g. a revised Investigator’s Brochure (IB) will have a list of revisions in the first few pages of […]
Institutional Review Board Members
Reminders for our Institutional Review Board reviewers about policies, using Clinical Research Administration (CLARA), and other news. Feel free to click on this blog even if you aren’t on the Institutional Review Board. You may get some pointers about what the Institutional Review Board is looking for when it reviews your studies.
A Reminder to Check Your Meeting Assignments Early!
Reviewers: Please remember to briefly check your review assignments as soon as you receive them, usually the Wednesday or Thursday before the meeting. The IRB needs to know as soon as possible if you have a conflict and cannot review a particular item. Please also let us know as soon as you can if you […]
Writing Contingencies: Keep the Criteria for Approval in Mind!
The criteria for approval of research are spelled out in federal regulations and in UAMS IRB Policy 7.1. Please review these criteria and keep them in mind when drafting contingencies. Some institutions, in fact, require IRB members to specifically state which criterion draft contingencies are addressing. While we do not go quite that far here […]
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.