If you’re not 100 percent certain whether your project requires IRB review and approval, your first step should be to submit a human subject research determination form. This form is much shorter and simpler than new submission form, it’s processed much more quickly than the new submission form is, and it gives you a more […]
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.
Choose staff roles and responsibilities carefully in CLARA
When adding staff to a new or current study in CLARA, you will be asked to assign roles and responsibilities to each person included on the study. Please be careful to select only roles and responsibilities that are actually applicable. For example, we see a lot of submissions come through indicating a staffer will be […]
Remember to mention “research” in recruitment materials
When you’re developing recruitment materials for your study, please ensure that the final product makes it clear that this project is research. We know this can be tricky in tweets or other social media blurbs that don’t give you a lot of characters to work with. However, it’s important to emphasize to prospective participants that […]
Tracked-changes documents need to show ALL changes — including deletions
When submitting revised documents to the IRB, either in response to contingencies or with modification forms, the IRB asks that you include clean and tracked-changes copies of all of the items being changed (particularly protocols, consents, and HIPAA authorizations). When creating tracked changes documents, please make sure all of your changes are tracked, including deletions. We have […]
Get help with the results modules of clinicaltrials.gov
ClinicalTrials.gov is piloting a process to provide one-on-one assistance for investigators throughout the results submission process. As part of the process, a member of the ClinicalTrials.gov results team would be available to help prepare you for results submission, orient you to the PRS (Protocol Registration and Results System), and walk you through the data entry […]
Read the Blog. Pass a Test (it’s open book). Earn CRS credit!
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 […]
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 […]