Create and Submit a Study

Show me: Create and Submit a Study

To create a study

1. From the Dashboard, click the Create menu and then select Create New Study.
2. Complete the pages. Click Continue to move to the next page.
3. Pay attention to the following pages:
   • Basic Study Information: use the following questions to indicate whether the study is a single - or multiple-site study or will be locally or externally reviewed.
     What kind of study is this?
     Will an external IRB act as the IRB of record for this study?
   • Attach the protocol: the study protocol is the only mandatory document to include.
   • Local Site Documents: add consent forms, recruitment materials and other documents specific to your study.
   • Study-Related Documents: if the study is a multi-site study for which you are serving as the sIRB, use this page to add templates for consent forms, recruitment materials, and other that participating sites will need to access.

4. On the final page, click Finish.

   Important! Clicking Finish does not send the study to the IRB office. It remains in the Pre-Submission state. When the study is ready for IRB review, the PI or PI proxy must submit it using the steps that follow.

You are taken to the study workspace. You can continue to edit the study (Edit Study button) until you submit it.

To submit a study for review

Tip: Only the study's PI or an assigned PI proxy can submit it for review.

1. From the study workspace, click Submit.
2. Click OK to agree to the terms.
3. Type your login credentials and click Submit.

Your study has been submitted and has moved to the Pre-Review state. You can log off the system.