Study Start-Up

The clinical study start-up process has been improved and automated. Clinical Research Connect is a new workflow application that was developed to support clinical research study start-up activities.  Clinical research staff will use the Clinical Research Connect workflow application to initiate and complete the study start-up process for all studies that require IRB-HSR review. The Clinical Research Connect workflow application assumes that you have a protocol and that funding has been secured.  At some point early in the process you will need to complete questions in IRB Protocol Builder as per the usual process.

The workflow system’s functionality includes: single data entry for a number of common data points across various systems, electronic submission to multiple functional areas, smart and proactive validations, automated notifications, electronic signatures, auto-generation of documents, and reporting.  The new automated process will allow everyone involved in the study start-up process to realize increased visibility.

If you have any questions about the process in the system, contact Clinical Trials Office at 434-924-8570.

The Grant Pricing Request Application allows study teams to access procedure cost information and create cart(s) with all the required procedures for the study. The research charge master (research rates) is updated by MC Finance and UPG at least annually and uploaded by SOM Clinical Trials Office (SOM CTO) to the Grant Pricing Request Application. Research rates for clinical research studies will be based upon the version of the research charge master that is in effect on the date the study is entered into Clinical Research Connect.  MC research prices will be guaranteed for the duration of the study. UPG does not guarantee their pricing.

If you have questions about the application, contact the SOM Clinical Trials Office at 434-924-8570.

The study start-up section is divided into 3 sections – compliance, budgeting and contracting.  Please note that the tasks in these 3 sections can be completed concurrently, keeping in mind, however, that some steps are dependent upon the completion of others (for example, you must have the approval of all other applicable review committees prior to obtaining IRB approval, and you must have IRB approval of your protocol before the study contract/agreement can be executed).

Once you have responded to all questions, you will have the opportunity to print or email your results to you inbox for reference.  To your left, you may also click through the menu, to see these topics on individual pages.