When completing a new submission form in CLARA, one question will ask you about the vulnerable populations that will be, or potentially could be, included in the study. This question is included because specific regulations come into play when vulnerable populations are included in research, and the IRB must make additional determinations when it approves […]

You’ve probably seen our previous blog items about “stacking” documents in CLARA. Briefly, all versions of a single document should be stacked atop one another in chronological order, with the most recent version on top. Please note that the clean and tracked-changes versions should be stacked separately, with all of the clean copies in one […]

In an attempt to reduce the number of times study teams have to get with sponsors regarding consent form changes, the IRB is changing its prereview of sponsored studies. When a new industry-sponsored study arrives at the IRB for review (remember that it may stop at several other offices before getting to the IRB), we […]

All studies involve some level of risk. Sometimes, those risks are clear, such as in the case of investigational drug and device studies where the test article may have side effects. Other potential risks are much more subtle, however. One risk we see often overlooked in draft consent forms is the risk to confidentiality. Confidentiality […]

Sometimes, for whatever reason, a study you’re working on will be audited more than once by the Office of Research Compliance. That means that you’ll be submitting more than one audit response to the IRB during the study. When that happens, the IRB asks that you “stack” new audit responses atop any previous audit responses […]

If you’re not 100 percent certain whether your project requires IRB review and approval, your first step should be to submit a human subject research determination form. This form is much shorter and simpler than new submission form, it’s processed much more quickly than the new submission form is, and it gives you a more […]

When adding staff to a new or current study in CLARA, you will be asked to assign roles and responsibilities to each person included on the study. Please be careful to select only roles and responsibilities that are actually applicable. For example, we see a lot of submissions come through indicating a staffer will be […]

When you’re developing recruitment materials for your study, please ensure that the final product makes it clear that this project is research. We know this can be tricky in tweets or other social media blurbs that don’t give you a lot of characters to work with. However, it’s important to emphasize to prospective participants that […]

When submitting revised documents to the IRB, either in response to contingencies or with modification forms, the IRB asks that you include clean and tracked-changes copies of all of the items being changed (particularly protocols, consents, and HIPAA authorizations). When creating tracked changes documents, please make sure all of your changes are tracked, including deletions. We have […]

ClinicalTrials.gov is piloting a process to provide one-on-one assistance for investigators throughout the results submission process.  As part of the process, a member of the ClinicalTrials.gov results team would be available to help prepare you for results submission, orient you to the PRS (Protocol Registration and Results System), and walk you through the data entry […]