The Study Resumption form is now available in CLARA to reopen a closed study. The form will ask why the study was closed and the reason for reopening it, whether there have been any protocol changes since it was last open, and whether any study activities have occurred since the closure. You will also have the […]
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.
Summer students or other new staffers joining your study?
If you are planning to add summer students or other new staffers to your study team, please remember to submit a staff change modification in CLARA. This form allows the IRB to confirm the new staffers have completed required training such as human subject protection training through citiprogram.org. In addition, other training and education requirements […]
A reminder regarding consent form formatting elements
When drafting informed consent forms, please make sure each page includes all the formatting elements required by IRB Policy 15.1. These include the protocol title or other specific identifier; the sponsor name; the institution where the research is being conducted; and page numbers and version date and number. These elements help researchers ensure that the […]
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 […]
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 […]