Steps to Completing a "Reportable Event" Form Are:
1) Log into eProst (Chapters 1 and 2)
2) Click on Protocol Team from within the Home Workspace page (Chapter 3)
3) Click the Protocols tab to display a list of all of the protocols on which you (the "user") have been included.
4) Click the title of the study in which a "reportable event" has occurred. This will open the Study Workspace
5) Click New Reportable Event from within the Study Workspace. This will launch the reportable event form (c.f. Figure 8)
6) Complete the reportable event form using the principles detailed in Chapter 5.
NOTE: Select the type of reportable event in question 1.1 and complete the rest of the form as appropriate
NOTE: Required fields are indicated by a red asterisk (*). If these fields are not completed, the form will not be submitted
7) Before exiting, be sure to save information with the SAVE link. When the "reportable event" SmartForm is complete, click on the FINISH button or EXIT link to be re-directed to the Study Workspace (c.f. Figure 7).
8) When the reportable event SmartForm is finalized, press Submit Reportable Event from the Study Workspace to review and attest to the contents of the Principal Investigator's Assurance Statement. As appropriate, click "yes" and then OK
NOTE: The system will permit only the PI to submit the reportable event form
9) eProst will forward the reportable event form to the HSRO for review. When a determination is made, the PI will be contacted via email.