If you’re facing any looming approval deadlines, please remember that there will be no IRB meeting on Tuesday, June 30, which is a fifth Tuesday. The IRB meets only on the first four Tuesdays of each month. If you need something approved around that time, please be sure to get it submitted to the IRB […]
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.
Free services for investigators, there for the asking
The CLARA Portal Facilitator (yes, that’s a real person; that position used to be known as the CLARA gatekeeper) no longer routinely performs in-depth content reviews of new submissions before sending them on to the IRB for review. However, that level of prereview is still available at no charge to research teams who request it, […]
A reminder to plan ahead — and to keep an eye on the calendar!
Please keep a close eye on the calendar when planning ahead to submit continuing reviews or any other submissions that have an approval deadline. If items need to go to full board, they should come to the IRB no later than the listed submission deadline to ensure placement on the agenda you’d like them to […]
Uploading documents and writing comments in response to contingencies
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” […]
How to check your study’s status in CLARA
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 […]
Get CRS credit for attending upcoming education classes
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 […]
A thought about gift card reimbursements
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 […]
Recruitment, expanded access, and education credits — upcoming educational offerings have it all
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 is a 5th Tuesday month
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 […]
Track changes — use’em, and please make sure the clean and tracked-changes versions match!
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. All […]