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Chapter 8: Submitting Amendments

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Steps to Submitting Amendments Are:


1)    Log into eProst (Chapters 1 and 2)


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


3)    Click on Protocols from the tabs in the center of the screen


4)    Within Protocols is a list of studies available to the user.  Click the appropriate study title to access the Study Workspace (c.f. Figure 7)


NOTE:  The Study Workspace will differ from that shown in Figure 7 because the current study has already been approved.  Therefore, the Study Workspace will include a section entitled Create with buttons for accessing various activities such as reports and amendments


5)    From within the Create section of the Study Workspace, click New Amendment button to access the amendment SmartForm.


6)    Complete the amendment SmartForm using the principles detailed in Chapter 5.


7)    Whenever the amendment SmartForm is saved, an Amendment Workspace, similar to the Study Workspace becomes available.  Activities available from the Amendment Workspace are required for the user to accomplish the following:


a.     Complete the amendment and the Principal Investigator's Assurance Statement required for amendment submission

NOTE:  The system requires the Principal Investigator to complete and electronically “sign” the PI Assurance Statement in order submit the amendment


b.    Respond to requests from reviewers


c.    Track the amendment through the approval process


d.    Access the amendable version of the study protocol (i.e. "view protocol") in order to make changes reflected in the amendment (see below)

NOTE:  The study protocol may also be changed by clicking the Edit Protocol button on the final page of the amendment SmartForm

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


e.     Complete the PI assurance form and submit the amendment via the Submit Amendment activity on the Amendment Workspace


Steps to Edit the Amended Study Protocol Form Are:


1)    Access the study protocol SmartForm via View Protocol button on the Amendment Workspace or the Edit Protocol button on the amendment SmartForm (see above)


2)    Edit the amended eProst protocol SmartForm to reflect the modifications described in the amendment. 

NOTE:  The eProst system will not permit the submission of an amendment without a corresponding modification to the study protocol SmartForm


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