Once a human subject research determination form is submitted into CLARA, the IRB office will determine whether the project meets the definition of research involving human subjects. If you get back the letter saying that the project is research involving human subjects, the next step is to start a new submission in CLARA. Please remember […]
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.
PI change requires a full modification form, and not a staff-only modification
The PI is the one study staffer who cannot be changed using a “staff-only modification” form in CLARA. To change a PI in CLARA, please submit a regular modification form, and not a staff-only modification. Please ensure the new PI’s CV is uploaded to his or her profile in CLARA as well. Using a regular […]
Please write long when responding to audits
When drafting responses to research compliance audits, please feel free to write long. Include as much information as you think the IRB might find helpful in your responses. Audits are sent to the full IRB for review, and the more information the IRB has at its disposal, the faster the IRB can process a response. […]
A fresh start when drafting HIPAA authorization forms
When creating a new submission that requires a HIPAA research authorization, it can be tempting to pick up the HIPAA form that was approved for a previous study and try to revise it for the new project. Here’s a bit of advice about that: Don’t do it. Really. Start fresh with the HIPAA authorization template […]
Upload documents separately rather than as protocol appendices
The IRB strongly discourages the attachment of study-related documents, such as consent forms, data collection tools, etc., directly to a protocol document as appendices. We prefer that these items be uploaded as separate documents with your CLARA submission. Separating them out makes them much less likely to be overlooked by a reviewer, and also simplifies […]
June has a fifth Tuesday — no IRB meeting that week
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 […]
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 […]