Here’s another reason to get your continuing review forms in early: The IRB now routinely closes studies once a continuing review (CR) has been expired for 30 days. Even studies that have a CR form pending, or that have contingencies outstanding from a pending CR form, are subject to closure if the approval has been […]
Blog
Remember to look at ALL tabs on an Excel Spreadsheet
Investigators will sometimes submit items to the IRB on an Excel Spreadsheet. This is most common at Continuing Review for PIs who use the Events and Deviations Table template that is available on the IRB’s website. This table is in the form of a spreadsheet with two worksheets on it. When looking at these tables, […]
A tip about formatting document titles in CLARA: No between-word underscores, please
We’ve noticed that some investigators routinely use underscores between words when typing in document titles in CLARA. We ask that you don’t use any underscores that aren’t strictly necessary, i.e. that aren’t an essential part of a document name. The underscores prevent the titles from wrapping across lines in CLARA, making it difficult for IRB […]
Start the New Year off right with a NICE review!
New to research? Or has it been a while since you’ve gotten some feedback on your research processes? If so, and if you have a study that’s about to be approved or that hasn’t enrolled any subjects yet, consider getting in touch with the Office of Research Compliance (ORC) to request a New Investigation Consult […]
What’s a Privacy Board?
Everybody knows the IRB reviews research. However, that’s not the IRB’s only role in research oversight. The IRB at UAMS also acts as the UAMS Privacy Board for HIPAA-related research issues. A Privacy Board is a review body established to act upon requests for a waiver or an alteration of the HIPAA Authorization requirement under […]
Scheduling reminder — no IRB meeting December 30
There will be no IRB meeting on Tuesday, Dec. 30, a fifth Tuesday. The IRB only meets on the first four Tuesdays of the month. Please keep that “missing” week in mind if you are facing deadlines for approvals and continuing review renewals. Also, remember that the campus will be closed for much of the […]
Did this study get a regulatory review? Check the “History” tab or the documents section
Investigator-initiated studies involving drugs or devices may cause you to wonder if the study needs review by the UAMS Office of Research Regulatory Affairs (formerly known as the Research Support Center). With luck, the various prereview processes each study undergoes should catch the need for a regulatory review before the new submission shows up on […]
When doing CITI training, be careful to pick the correct institution!
When you log into the human subject protection training program at citiprogram.org, you’ll be asked to affiliate with a particular institution. Please be careful to select UAMS to ensure that you are directed to the correct training! We’ve noticed that some people have accidentally affiliated with UALR, which, while also part of the University of […]
PI change? Maybe not…
When reviewing items in CLARA, particularly contingency responses, you’ll notice that the author’s name of a particular comment will be visible, and will sometimes have a “Principal Investigator” notation next to it. This notation only indicates that the person responding, who is often a study staffer and not the PI, is acting on the PI’s […]
A hint for the biological specimens questions on the new submission form
When completing a new submission form in CLARA, you may encounter a question asking whether you will obtain biological specimens as part of the research. This question should be answered “yes” only if you will be obtaining the actual specimens, either directly from subjects, or from a secondary source, such as a pathology lab or […]