We know the regulations governing human subject research can seem cumbersome. But when we read about the things that happened before such research was regulated, we can understand their intent better. A recent National Public Radio story about raced-based testing of chemical agents during WWII highlights the types of activities that seem to be have […]
Blog
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 […]
An alphabet soup of IRB acronyms
We’ve had several requests to put together a list of commonly used IRB acronyms. Below is what we could come up with right off the top of our heads. Please let Edith Paal in the IRB office know if there are others you’re curious about – we can track them down for you. AARHPP – […]
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ARIA, the IRB’s old electronic submission system, is no longer active, but you can still find items that you uploaded to current studies that originated in the ARIA system.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 to the “Forms” tab. If the study was open before […]
Yikes! How closely should I review this gigantic case report form?
The short answer: You may not need to review it at all. Please check with the IRB office (Edith Paal prereviews almost all of the new submissions before you see them, so she’d be a good place to start) to see if you need to do anything with the CRF in the file. The less […]
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 […]
Questions about audits? Feel free to ask ORC staff or study teams
If you’ve been assigned an audit to review for an upcoming meeting, and have some questions about the audit report, please keep in mind that you are welcome to contact Office of Research Compliance (ORC) staff before the meeting for more information. The auditors involved in each audit are listed on the front page of […]