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Chapter 6: Creating a New Protocol


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Steps to Create a New Protocol Are:

  

1)    Log into eProst (Chapters 1 and 2)

 

2)    Click on Protocol Team from within the Home Workspace page (Chapter 3)

 

3)    Click New Protocol on the left side of the Home Workspace to access the forms that must be completed for study submission (c.f. Figure 6). 

 

4)    Complete the form using the principles detailed in Chapter 5.

When the "new study” SmartForm is complete, click on the FINISH button or EXIT link to be directed to the Study Workspace (c.f. Figure 7). 

 

The Study Workspace is similar to the My Inbox workspace described in Chapter 6.  However, the activities available from the Study Workspace are required for the user to accomplish the following:

 

a.     Complete the study application and forms such as those for Conflict of Interest (c.f. Chapter 8) and the Principal Investigator's Assurance Statement required for study submission

NOTE:  All study team members must complete the Conflict of Interest Disclosure in order for the system to permit the Principal Investigator to validate and submit the new study application 

NOTE:  The system requires the Principal Investigator to complete and electronically “sign” the Principal Investigator’s Assurance Statement in order submit the new study application

 

b.     Respond to requests from reviewers

 

c.      Track the submission through the approval process

 

d.     Manage the study (i.e. submit amendments, continuing reports etc) after its approval

 

5)    When the eProst form and submission of all Conflict of Interest Disclosures are complete,  the PI may forward the study for departmental approval by clicking Submit Protocol which is available within the My Activities section of the Study Workspace 

NOTE:  The system will permit only the PI to submit the study

 

6)    When the Submit Protocol activity is selected, the Principal Investigator’s Assurance Statement will open in a separate window.  The PI should read the statement and must select "yes" to acknowledge his/her agreement. 

 

7)    Click the OK button to submit the Principal Investigator’s Assurance Statement and submit the study.

NOTE:  Study will be forwarded for approval from the academic department of the PI.  After departmental approval, the study will be forwarded to any applicable Ancillary Committees for approval as required.  The study will then be forwarded to the HSRO for IRB review 

NOTE:  If reviewers request study modifications, these will be communicated to the PI and designees via email and the study will be listed in the My Inbox tab and the system will place the study into a state that allows editing



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Figure 9: The Study Workspace



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