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Preface


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eProst is the Human Subject Research Office's (HSRO) web-based, computer system that automates the entire lifecycle of human subject research activity. eProst is designed to support both behavioral and biomedical research studies, including studies requiring IRB approval by the full panel or those that require expedited or exempt review. We have chosen the eProst system because it will provide more information while reducing the cycle time required to gain IRB approval of a newly submitted study, amendment and continuing/final report.

Through eProst, human subject research studies may be:

1)     written and submitted to the University of Miami's Institutional Review Board (IRB)

2)      reviewed by the IRB

3)      tracked through the review process by Principal Investigators and others

4)      modified as necessary to gain IRB approval

5)      amended by investigators

6)     managed by means of continuing reviews and reports such as those required for adverse events, study deviations, etc.

This step-by-step guide should facilitate the use of eProst to make the IRB process nearly paperless for investigators and reviewers.  For additional information about the eProst system or about IRB policies, regulations and the review process, the UM Human Subjects Research Office maintains a home page at http://hsro.miami.edu and a help desk at 305-243-3195.   

In writing and/or revising this eProst guide, a goal is to make it an easily comprehensible reference manual for investigators and their staffs, for IRB members,  reviewers and oversight staff from the Human Subject Research Office, for other University offices and for individuals authorized to access the eProst system.  Many of the chapters may be intuitive for some but necessary for others.  We ask for flexibility in this regard since we sought to create a manual that avoids its sometimes definition as "an object that raises the monitor to eye level".

 

In writing this eProst guide, we also recognized that much information is repeated to fit different situations.  This is deliberate to avoid pitfalls that may occur when computer jargon is misinterpreted (see Preface Figure 1). Investigators may find it helpful to read the chapters relevant to their specific activities while using reference information from other cited chapters. 



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Preface Figure 1 – confirming that computer jargon can be
misinterpreted. Perhaps the HSRO "help desk"
(305-243-3195) could have saved the window or mouse?

 

Special thanks are due to HSRO Education Coordinator Joey Casanova who led in the development of this guide.  He and the HSRO team emphasize that while much effort was expended to make this guide as complete and useful as possible,  it remains a 'living document' that will be reviewed, revised and supplemented as needed to ensure that it accounts for policy changes, new concepts of organization and the questions and concerns of the community of eProst users.  Comments and suggestions on the organization and contents of this guide are welcome.  These may be addressed to IRB members or to the Human Subject Research Office (HSRO).

 

 

                                                                        Myron Rosenthal, Ph.D.

                                                                        Vice Provost for Human Subject Research



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