So, you’ve submitted a new submission, modification, or continuing review form in CLARA, and now the IRB has sent back a contingency that requires you to upload some new or revised documents. You prepare the documents, log into CLARA, click on the protocol, click on the documents tab, and then you’re stuck. The “upload new documents” […]

Wondering where your study is in the review process? The “History” tab in CLARA documents everything that has happened to a study since its submission. It will let you know where in the review process your study is. This feature is a big change from the IRB’s old submission system, ARIA. There was no way […]

Credit hours for the Certified Research Specialist program will be available for several upcoming classes: Advanced Research Ethics, Tuesday, April 14th, from 8 am to 12 noon; IDW 114A/B Essentials of Quality Human Research, Wednesday, April 29th, from 9 am to 3:15pm; IDW 114A/B Genetic and Genomic Research, Wednesday, May 13th, from 11:30am to 12:30 […]

Using gift cards to compensate study subjects for their participation is fairly common among studies that offer reimbursements for time and inconvenience. The IRB does not require too many specifics about what kind of gift card will be offered in submissions. The IRB will typically accept language along the lines of “a $25 gift card” as […]

Mark your calendar to attend one (or both) of these upcoming classes. You’ll get information that may help your research, and earn education credit too. A webinar titled “Cracking the Code for Clinical Trial Recruitment: A Sponsor’s Perspective” is scheduled for Wednesday, March 18, 2015  from 11:00 am – 12:30 pm in COPH/G230. The webinar will be […]

March has five Tuesdays, but the IRB, per its standard practice, will not meet on the 5th Tuesday, March 31st. Please keep this gap in meetings in mind when planning for the review of anything that is facing a review deadline. And for those planning ahead, June, September, and December will also have 5th Tuesdays […]

When submitting protocol and consent form revisions, the IRB asks that you submit clean and tracked-changes versions of revised documents. Microsoft Word makes it easy to create clean and tracked changes versions of items created in Word. Please note that your clean and tracked changes versions should exactly match each other, except for the tracking. […]

When completing new submission forms, you’ll encounter a question that asks you to check the type of consent process(es) to be used in the research. The four response options are Assent; Parental Permission (Pediatric Consent); Informed Consent; and Requesting Waiver of Consent Process. We’ve seen some creative answers given to this question when PIs are […]

All protocols, consent forms, HIPAA authorization forms, and other study documents subject to revision should include a version number and date on each page. Whenever you update a document, please remember to update the version number and date on each page to reflect the changes. Also, when submitting tracked changes versions of documents, please make […]

An upcoming webinar on data security will offer CRS elective credit. The UAMS Office of Research Compliance is to host the PRIM&R webinar “Data Security Incidents – the Role of IRBs and Information Security” on Thursday, February 26, from 12:00-1:30 p.m. in the Walton Auditorium on the 10th floor of the Cancer Institute. An overview of […]