As part of our continuous lean process improvement, the IRB Office has been seeking ways to streamline and simplify IRB submissions for investigators. Reviewing recent data, we found that more than 35% of all Continuing Review submissions required multiple corrections, greatly delaying final approval.
The most common corrections include:
- Apparent errors in subject accrual numbers – 36%
- Selection of the wrong study status – 22%
- Incomplete form (questions and/or sections left blank) – 11%
- Uploading new versions of approved attachments as new documents – 11%
- Failure to update the application and documents with proposed changes – 9%
- Submitting last year’s status information from a copied form – 5%
In response to these data, the IRB Office has completely revised the Continuing Review Form to make it more user friendly and error-proof. This version features new functionality that enables the iRIS system to hide or display questions in the form based on your answers. For most users, this will result in significantly shorter forms that are accurate and complete. This should greatly improve approval turn-around time!
- Fewer sections
- Many questions revised to improve clarity
- Shorter form for minimal risk research, repositories, and studies not involving subject contact
- More intuitive and complete Subject Enrollment section
- Attachment sections (Revised Application, Consent Forms, Study Documents) appear only when required
- AE Summary Log for non-reportable AEs and deaths has been eliminated
- ‘Smart Prompts’ alert users to update study components that require changes and advise when additional action is needed
- Form modified to prevent users from submitting incomplete applications
To take a test drive, click HERE.