Contributing Members Workflow

Step 1: Become A Member

By becoming an Affiliate Member you can submit data from your Institution and be a part of ongoing projects. Follow steps 2-5 to proceed. By becoming an Active Member you can propose new projects to be considered by the Fetal Heart Society, for more information visit the Research section of the website.  Active Members are voting members of the Fetal Heart Society.  Become a member now!

Step 2: Begin Business Agreement Process

The BAA is an agreement signed between your Institution (“Covered Entity”) and the University of Utah (“Business Associate”) that is needed in order for the University of Utah to receive data from each institution for the Fetal Heart Society. The Business Associate Agreement (BAA) template is available in the Resources section of website. Complete with your institution details, review with your institution’s legal department, and send to the Project Manager at the Data Coordinating Center (DCC) for review by the University of Utah Privacy Office.

Step 3: Obtain Data Use Agreement

A data use agreement may be necessary to transfer data from your Institution to the University of Utah Data Coordinating Center, along with the BAA. Work with your research and legal department to find out if a DUA is required by your Institution.

Step 4: Submit IRB Application

Begin the IRB submission process at your institution. If you are interested in participating in a certain project, obtain the protocol summary for that specific project from the Fetal Heart Society website, under the ‘Research’ tab, and use the umbrella IRB template or a study-specific IRB template depending on your institution’s requirements. Contact the Project Manager at the DCC with questions.

Step 5: IRB Approval & Submitting Patient Data

Once the BAA is in place and your IRB is approved, you may begin submitting data. The process for submitting data and images is detailed on the website under ‘Step 2: Getting Started’. We are using OpenClinica for our online database and XNAT for our image repository.

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