The Gilstrap Center Services

The Gilstrap Center is responsible for coordinating and facilitating all aspects of conducting clinical trials and interventional studies, including clinical operations; oversight of all committees and working groups; development of the protocol, consent, manual of operations and all amendments; definition and management of study budgets; database development and maintenance; monitoring of study progress; coordination with data analysis, presentations, and publications.

Generally, there are many factors that go into developing a successful study from start to finish. Each of these factors are governed by specific rules and oversight and can sometimes pose problematic issues for investigators if not properly handled. The overall goal of the Gilstrap Clinical Trials Coordinating Center is to bridge the gap between investigators who are eager to do clinical research and the entities set in place by the institution to regulate and monitor human research by providing a medium that can facilitate this process. By utilizing this service investigators can focus on the “research side” of research instead of the “business side” of research.

Services Offered:

• Administrative management
  • Clinical trial agreements
  • Subcontracts
  • Budget creation & negotiations
  • Invoice dispersal

• Regulatory Document management
  • IRB submissions & maintenance (initial, continuing reviews, modifications)
  • Clinical Trials (CT).gov registration & maintenance
  • FDA submissions (IND, IDE) and management

• Study set up and initiation
  • Study folder creation
  • Study material purchase

• Conduct study procedures
  • Subject screening and enrollment
  • Specimen Collection, Processing, and Shipping & Handling

• RedCap project creation
  • Case report form (CRF), randomization schemes
  • Survey/questionnaire disbursement and management
  • Twilio interfacing

• Chart Abstraction and Data entry & management
• Study closure procedures