You can now earn credit toward earning or maintaining your Certified Research Specialist (CRS) credential at your convenience, just by reading the IRB’s Research News Blog! Online quizzes based on blog entries are now available! So – Read the blog, pass the (open-book) test, and earn 0.5 credit hours! At your convenience! We plan to […]
Research News
Investigators, study staff, research administrators — keep up with research happenings in our Research News and Tips blog. Reminders for working with the Institutional Review Board, Clinical Research Administration (CLARA) tips, educational opportunities — we’ll post all that, and more, on this blog.
Looking back into the mists of history…a.k.a. finding items in ARIA
ARIA, the IRB’s old electronic submission system, is no longer active, but you can still find items that you uploaded to current studies that originated in the ARIA system. How? By looking in the right place in CLARA. When you log into a study, go the “Forms” tab. If the study was open before the […]
Reminder — the IRB does not need to routinely review or approve case report forms
When submitting studies to CLARA, please keep in mind that the IRB does NOT routinely need to see case report forms (CRFs). If they are submitted with a study, the IRB will not review them closely and will, in fact, try to remember to ask you to delete them from the submission before we approve […]
Course instructors – help us help your students get set up in CLARA
If you are leading a class in which all of the students will be required to make a submission in CLARA, we can help get your students’ accounts activated before they begin their new submissions. Please send Kate Henning an email at khenning2@uams.edu and cc irb@uams.edu with a list of all students whose CLARA accounts should […]
Answering the “How will potential subjects be identified” question on the new submission form
The “Subjects” section in the new submission form includes the following question – How will potential subjects be identified? When completing the form, keep in mind that this question is asking how you plan to find potential subjects in the first place. Every now and again we see people describe their plans for identifying the […]
Reminders regarding human subject research determinations in CLARA
Once a human subject research determination form is submitted into CLARA, the IRB office will determine whether the project meets the definition of research involving human subjects. If you get back the letter saying that the project is research involving human subjects, the next step is to start a new submission in CLARA. Please remember […]
PI change requires a full modification form, and not a staff-only modification
The PI is the one study staffer who cannot be changed using a “staff-only modification” form in CLARA. To change a PI in CLARA, please submit a regular modification form, and not a staff-only modification. Please ensure the new PI’s CV is uploaded to his or her profile in CLARA as well. Using a regular […]
Please write long when responding to audits
When drafting responses to research compliance audits, please feel free to write long. Include as much information as you think the IRB might find helpful in your responses. Audits are sent to the full IRB for review, and the more information the IRB has at its disposal, the faster the IRB can process a response. […]
A fresh start when drafting HIPAA authorization forms
When creating a new submission that requires a HIPAA research authorization, it can be tempting to pick up the HIPAA form that was approved for a previous study and try to revise it for the new project. Here’s a bit of advice about that: Don’t do it. Really. Start fresh with the HIPAA authorization template […]
Upload documents separately rather than as protocol appendices
The IRB strongly discourages the attachment of study-related documents, such as consent forms, data collection tools, etc., directly to a protocol document as appendices. We prefer that these items be uploaded as separate documents with your CLARA submission. Separating them out makes them much less likely to be overlooked by a reviewer, and also simplifies […]