The FIRST Program offers a comprehensive menu of services to clinical investigators in the Department of Surgery. To request services, please complete the Services Request Form.
Each Services Request Form is reviewed by the FIRST Program Director and Clinical Research Administrator (CRA). Initial follow-up with the investigator typically will occur within 24 hours. Requests are reviewed for alignment with the FIRST Program’s mission and capacity to respond to the request with the proper level of expertise and guidance. Requests are then prioritized based on several factors, including alignment with Department of Surgery research priorities, existing or potential for extramural funding, and availability of staff and other resources.
The FIRST Program is designed to handle a full assortment of activities that are an essential part of most clinical research programs. These activities include, but are not necessarily limited to, research mentorship, protocol guidance and development, regulatory support, biostatistics support, study coordination, and grant application preparation and review.
- Assist with understanding and navigating the IRB process
- Review IRB applications prior to submission
- Assist in preparing and submitting new IRB applications, amendments, AE reporting, continuing reviews, and termination reports
- Monitor and improve clinical research compliance
- Facilitate the completion of human subjects protections training
- Assess labs for IRB audit readiness to ensure a successful audit
- Assist in implementing regulatory corrective actions, as needed
- Assist with protocol development for investigator-initiated studies
- Develop standard operating procedures and manual of operations
- Provide support with database building as well as data collection, coding, entry, and validation
- Subject screening, recruitment, and enrollment
- Clinical trial budget development and negotiation
- Provide support for biological sample processing, storage, and documentation
- Industry communication
- Provide guidance regarding the design and validation of surveys and other patient-reported questionnaires
- Identify research funding opportunities
- Individual mentorship across the research spectrum (e.g., design, methodology, biostatistics, writing, etc.)
- Help to identify potential research collaborators
- Pre-submission grant review. Click here for details
- Deliver individual and/or group education and training for research staff
- Presentations about FIRST Program at Division meetings