Information for Study Sponsors
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).
Sponsor document collection
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:
- Final protocol
- Informed consent (draft)
- Budget template (draft)
- Clinical trial agreement (draft)
- Investigator brochure
- Device manual
- DSMB charter (at minimum, draft)
- Lab manual
- Recombinant DNA Advisory Committee letter
- Pathology manual
- Pharmacy manual
- Imaging manual
- FDA letter (IND/IDE designation)
- Participant contract materials
- Advertising materials
- clinicaltrials.gov #
- Completion of the provided study information sheet
Study Development (timeline goal: ~4 weeks)
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 any
other 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
Activation Process (timeline goal: ≤65 days, pending project type and your commitment to timelines)
Budget creation and negotiation, contract negotiation, and IRB committee reviews are completed in
parallel. The Office of Clinical Trials will contact you during the Study Development process once we have
developed 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 these
three 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 contact
the Office of Clinical Trials at email@example.com or (601) 815-5000.