Tips for completing the new submission form in CLARA

Paying close attention to each question on the CLARA new submission form and writing responses that include the specific information requested will help your study get through the review and approval process faster. Each new submission form query addresses a key piece of information that either the IRB or another institutional office needs to approve studies. The information you provide will help support the IRB’s criteria for approval and any special determinations the IRB needs to make, such as whether a waiver of HIPAA authorization is appropriate. We look closely at the form answers and will return any incomplete or incorrect responses to you for correction with a contingency.

We therefore ask that you read each question closely and give specific responses to each question asked. While it can be tempting to cut and paste the same response to multiple questions, we’ve noticed that this often doesn’t give us the information we need. Including only the specific information requested will ensure that the IRB’s study database is correct and that our approval decisions are adequately supported.