Those who pay close attention to these things (and we hope that’s all of you!) may have noticed some recent changes to the HIPAA section of the new submission form. The changes include rewording some queries to make it clearer that the form is asking you to indicate which specific PHI elements you are going […]
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.
Picking the right “document type” for your informed consent material in CLARA
When uploading documents in CLARA, you’ll encounter a dropdown list of different document types. Please be careful to choose the type that matches the document you’re trying to upload. We’ve noticed that, in particular, the seven informed consent-related options tend to get selected a bit randomly. They all begin with “Consent, Assent and HIPAA;” the […]
Remember to address both data AND specimen handling in your protocol, when applicable
If your study involves keeping data and specimens for possible future research use, please remember to address the security and storage of both the data and the specimens in your protocol. We very often see what we think of as protocols with good intentions – their storage and use sections start out by mentioning both […]
Upcoming (Feb. 5) consent process workshop offers CRS credit
We’ve all heard the saying, “Consent is a process, not a form.” An upcoming workshop at Arkansas Children’s Hospital promises an innovative look into the process of informed consent with your study subjects, and offers Certified Research Specialist (CRS) credit to boot. The first hour of this 2-hour class will review the regulations, policies, and […]
January 28th webinar offers CRS credit!
Do you work on studies listed on clinicaltrials.gov? If so, an upcoming class may be of interest to you – and you’ll get Certified Research Specialist (CRS) credit for attending. The Office of Research Compliance will present a webinar “Reporting Failed Trial Data: New Rules for ClinicalTrials.gov” on Wednesday, January 28, 2015, from 12:30-2:00 p.m. […]
Help us to help you (Part 2) — CLARA question? It helps to have Lync available on your computer
If you’re having trouble using CLARA, please give us a call in the IRB office – we’re happy to help out. Sometimes it would be really helpful to us to be able to physically see where you are in CLARA. This is possible through the screen-sharing function in the Lync communication system (most commonly used […]
Help us to help you (Part 1) — know your protocol number
We’re numbers people here at the UAMS IRB. IRB protocol numbers, more precisely – everything related to individual studies is filed under a specific protocol number. So when you call or email us with a question about a specific study, please be sure to have the protocol number either at hand or included in your […]
Please upload CVs to CLARA profiles
Please help the IRB meet its requirement to verify that PIs are qualified to carry out their studies by making CVs easy to find. The simplest way to link CVs to study protocols is to upload CVs directly to CLARA profiles, rather than to individual studies. Tying a CV to the profile will automatically link […]
Remember, CLARA accepts Word documents
In a change from the IRB’s previous online submission system, ARIA, our current system, CLARA, accepts study documents created using Microsoft Word. In the ARIA days, all study documents had to be converted to PDF. The new system will accept documents in Word format, so that conversion is no longer required. Keeping everything in Word […]
Studies subject to closure 30 days after continuing review expiration
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 […]