When you’re drafting contingencies during your study reviews, you’ll notice an “attach to letter” box at the bottom of the contingency box. When drafting contingencies before a meeting, please do not check “attach to letter.” Checking this box makes the draft contingency visible to the study team, even before a contingency letter is sent out. […]
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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 […]
Remember, PIs can’t upload anything once a study’s assigned to an agenda
When you’re reviewing a study, you’ll sometimes notice that a submission is missing a document. Your first temptation may be to email the study team to ask them to upload the missing item. However, please keep in mind that once a study has been assigned to an agenda, PIs cannot make any more changes to […]
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. […]
Please get reviews done by Monday
When it’s your week to serve on an IRB committee, please try to have all of your assigned reviews done and any comments or draft contingencies entered into CLARA no later than Monday, the day before the meeting. The chair aims to have assignments completed and the agenda made available to members by Wednesday the […]
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 […]
Considering appeals from PIs
PIs have an opportunity to appeal IRB decisions, such as not approving a proposed modification, or a finding of serious or continuing noncompliance. To do so, they draft a written appeal request and send it, along with any supporting documentation, to the IRB office, where staff then assign it to an agenda using the “office […]
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 […]