Clinical Trials Activation Process
The UMMC Office of Clinical Trials works directly the Sponsors/CROs 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.
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
The information in these documents is required for study development within UMMC. Our study staff are instructed to wait for the receipt of all applicable documents before moving forward with the initiation of the IRB application, budget, and contract process. Since the study development process will not begin until we have received these documents, your timely attention is appreciated.
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. We look forward to working with you.