The Office of Clinical Trials at UMMC is focused on expanding our clinical research efforts through our state-of-the-art clinical research and trials unit, clinical research management system, and expanded administrative support for clinical researchers. The Office of Clinical Trials is part of UMMC’s effort to create an optimal research environment by removing barriers to successful research operations, streamlining administrative processes, and providing best-in-class customer service and expert support. One of the Office of Clinical Trials’ first initiatives is the transformation of the clinical trials activation process (TACT).
Information for sponsors/CROs regarding UMMC’s Transforming the Activation of the Clinical Trials Process.
UMMC works with the sponsors/CROs directly to expedite study activation of clinical trials. We will work closely with you to achieve a shared goal of attaining study activation while maintaining the highest level of accuracy.
At UMMC, we have three phases of activities to prepare a new industry-sponsored study: sponsor document collection; study development; and activation (contract, budget, and IRB approval).
The first step in this process is collecting information from you that is vital to UMMC during the study development and activation process.
If applicable to your trial, the specific documents that we require are:
Once all study documents are received, the investigative team will begin the necessary activities to enter the activation process as applicable, including:• Disease Oriented Group approval (depending on the department; may occur earlier in some departments)• Scientific of Departmental Committee Reviews• Accrual feasibility assessment• Gathering budget elements including personnel efforts, pharmacy, radiology, laboratory, and anyother required service costs• Drafting the informed consent document on our UMMC template and obtaining your approval• IRBe Financial Disclosures for all study staff• Preparation of the IRB application
Budget creation and negotiation, contract negotiation, and IRB committee reviews are completed inparallel. The Office of Clinical Trials will contact you during the Study Development process once we havedeveloped the activation timeline. We will provide you with the anticipated dates for receipt of budget,contract redlines, and IRB approval from UMMC. In our accelerated process, we aim to complete thesethree activities in parallel with your commitment to this accelerated review schedule.
If you have any questions regarding the process to develop and activate a study at UMMC, please contactthe Office of Clinical Trials at email@example.com or (601) 815-5000.