There’s an important text box in the CLARA new submission form’s “Basic Details” section. It follows the question “Which of the following support types will this study use?” and is triggered by selecting “internal support.” The text box directs you to “Describe your study support.” This response addresses important institutional needs. Both ACH and UAMS […]
A reminder to check notes and draft contingencies in CLARA
When reviewing studies, please remember to take a look at the notes and draft contingencies already entered into CLARA by the office staff. We use these CLARA functions to indicate areas that we think need may need additional input by the IRB, and to note draft contingencies the IRB may want to consider. Please note […]
Are you targeting a non-English-speaking study population?
The IRB has special requirements for investigators doing research projects designed to enroll non-English-speaking populations. PIs who expect enrollment of non-English speakers at the time of initial submission must submit translated copies of consent forms, study information sheets, brochures, diaries, and any other items that will be provided to subjects. The submission must also include […]
Reopening a closed study in CLARA
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 […]
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 […]
Notes and contingencies in CLARA – which options to use?
Here’s a quick recap of the options available to reviewers to note comments and contingencies when they’re reviewing CLARA submissions. The “contingencies” option is for items that require a response from the study team. The “note” option can be used when you want to make a suggestion to the study team, or to bring something […]
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 […]
Please look at ALL agenda items — even the ones that aren’t assigned to you
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 […]