Getting Started and Creating a New Study Submission

From the Dashboard, click Create, select IRB and click Create New Study. This starts your application and opens a smart form where you answer basic questions about your study.

Download the applicable Proposal Template from the Library in the IRB Module (click on Library, then click on Templates). Additional information about Proposal Templates can be found on the IRB Submission Forms page.

• Funding – Include to ensure the specific regulatory requirement of your study sponsor are adhered to.
• Local Study Team Members – Ensure that all research personnel have completed CITI Human Subject Research Training.

Note: You can check your research team members training after they’ve been added to the smart form using the training report on the study workspace. Simply exit the Smart Form to be taken to the study workspace and click on Study Team Training Report.

• Study Scope – Identify if this study includes investigational drugs or devices.
• Local Research Locations – Identify where study activities will take place. This list will be periodically updated with your fellow researchers’ additions.

Upload copies of the consent forms, recruitment materials and other documents (e.g., survey measures, interview guides, supplemental forms) specific to your study. Be sure to upload the documents in the correct sections.

Note: In order to use the full functionality of the system, please upload study materials in Word Document format when possible. It is required to have the Proposal Template as well as Informed Consent Forms in Word Doc format. 

On the final page, click Finish. You will be taken to the study workspace.

You can continue to edit your submission (click Edit Study button) or you can submit your study for IRB review by clicking Submit.

To submit a study for review, from the study workspace, click Submit. Carefully read the PI attestation and click OK to agree.