Please take a quick look at all the items on your meeting agenda – even the ones assigned to other reviewers. You may have some expertise in a particular area that would be helpful to the IRB as it reviews a particular study that you’re not assigned to. Your contributions on *all* agenda items are […]
Thorough summaries of modifications will speed review and approval
When submitting a study modification, please make sure that the proposed changes are clearly indicated. Some simple changes can be briefly described in the modification form and included in clean and tracked-changes versions of revised documents. However, more extensive changes may require more explanation and a separate summary. For example, if a sponsor has provided […]
Need more information about a modification? Feel free to ask!
When reviewing a proposed modification, remember that reviewers can (and should!) ask for summaries of complicated submissions and/or a description of what the modification means for the study. These items are sometimes within the revised document itself, e.g. a revised Investigator’s Brochure (IB) will have a list of revisions in the first few pages of […]
A Reminder to Check Your Meeting Assignments Early!
Reviewers: Please remember to briefly check your review assignments as soon as you receive them, usually the Wednesday or Thursday before the meeting. The IRB needs to know as soon as possible if you have a conflict and cannot review a particular item. Please also let us know as soon as you can if you […]
Writing Contingencies: Keep the Criteria for Approval in Mind!
The criteria for approval of research are spelled out in federal regulations and in UAMS IRB Policy 7.1. Please review these criteria and keep them in mind when drafting contingencies. Some institutions, in fact, require IRB members to specifically state which criterion draft contingencies are addressing. While we do not go quite that far here […]
Having trouble opening a PDF in CLARA?
Some documents uploaded as PDFs in CLARA can be difficult to open. If you have trouble accessing a PDF in CLARA, please try accessing the document using a different browser. We’ve checked with IT, and IT says that some browsers have internal settings that won’t open a PDF correctly.
UAMS Record Retention Policy Addresses Research
Researchers often wonder how long they need to keep their study documents. Several different regulations address document retention, and it seems they all give different direction regarding how long to keep records. New UAMS Administrative Guide Policy 3.2.01 addresses record retention requirements for several different campus activities, including research. Please review this policy when making […]
Does my project need IRB review? There’s a CLARA form for that!
If you are wondering if your project is human subject research requiring IRB review, please log in to CLARA and submit a Human Subject Research Determination form. This form is designed to elicit the information the IRB needs to assess whether your project meets the regulatory definition of research involving human subjects. We are happy […]
A reminder to close completed studies
When you’ve completed your study, please log in to CLARA and submit a study closure form. It’s appropriate to close the study once you have completed study activities that involve identifiable data. Once the IRB office processes the form, the study will be officially closed in the IRB system. If you fail to close a […]