Our Services
The Clinical Research Office was established to provide clinical research support for the Department of Surgery in order to improve efficiencies, streamline and enhance research within the department. We strive to provide excellent compliance, enrollment, study approval timelines for all of our investigators projects.
The Clinical Research Office (CRO) is a central location for Investigators within the Department of Surgery to develop and conduct clinical research projects. Our goal is to help investigators efficiently get projects approved for study subject enrollment. We conduct a high level of regulatory compliance and assist in all aspects of conducting human subjects research within the department.
The CRO works across multiple divisions of surgery. We support PI initiated research, industry research and grant funded human subject trials.
Our wide range of services include:
Feasibility & Protocol Support
- Scientific and logistical feasibility reviews
- Support for pre-award grant or proposal submissions
- Protocol development or scientific editing
- Schedule of Events (SoE) creation
- Investigator Brochure (IB) and IND/IDE Collaboration
Regulatory Planning
- Regulatory pathway consultation (FDA IND/IDE/Exempt)
- Determination of human subjects involvement
- Guidance on ICH-GCP, HIPAA, and institutional policies
- Support with multi-site or centralized IRBs
Budget & Coverage Analysis
- Medicare Coverage Analysis Review (MCA)
- Clinical Trial Billing Compliance (NCT/CPT)
- Budget development (startup, per-patient, overhead, etc.)
- Budget negotiation with sponsors or CROs
- Cost sharing and departmental budget planning
Contract & Agreement Negotiation
- Confidential Disclosure Agreements (CDAs)
- Data Use Agreements (DUAs)
- Material Transfer Agreements (MTAs)
- Subaward creation and negotiation
- Clinical Trial Agreements (CTAs)
IRB & Regulatory Submission
- IRB new study submissions and amendments
- Assistance with informed consent forms (ICFs)
- Regulatory binder preparation
- ClinicalTrials.gov registration support
- IND/IDE submission and maintenance
Operational Setup
- Site qualification and sponsor/CRO questionnaires
- Delegation of authority logs
- Site Initiation Visit (SIV) coordination
- Research pharmacy and lab coordination
- Standard Operating Procedures (SOPs) setup
Clinical Coordination Support
- Assignment of a Clinical Research Coordinator (CRC)
- Source documentation templates
- Visit scheduling and patient tracking systems
- EPIC or EMR integration planning
- Investigational product (IP) handling procedures
Participant Recruitment & Retention
- Study listing on institutional registry/website
- IRB-approved recruitment advertisements
- Community and clinician outreach support
- Patient pre-screening services
- Participant compensation process management
Informed Consent Process
- Consent process training for staff
- Multilingual consent support
- Remote or eConsent setup
- Waiver or alteration of consent applications
Data Management
- REDCap or EDC platform setup and support
- Case Report Form (CRF) design
- Data entry training and assistance
- Source-to-CRF verification support
- Integration with institutional data systems
Safety & Regulatory Monitoring
- AE/SAE identification, reporting, and follow-up
- Data Safety Monitoring Board (DSMB) support
- Annual continuing review and report preparation
- Protocol deviation tracking and reporting
Quality Oversight
- Internal QA audits
- Mock FDA audits and site inspections
- GCP compliance checks
- Monitoring visit coordination with sponsor/CRO
Performance Metrics & Dashboards
- Enrollment tracking and reporting
- Financial performance dashboards
- Protocol compliance tracking
- Monitoring reports review support
Administrative Close-Out
- IRB study closure forms
- IND/IDE close-out filings
- Regulatory binder finalization
- Document archiving and records retention
Financial Close-Out
- PI financial responsibility sign-off
- Final invoice generation and payment tracking
- Budget reconciliation and close-out reports
- Effort certification support (for NIH grants)
Reporting & Results Disclosure
- ClinicalTrials.gov results posting
- Sponsor-required final study report submission
- Publication tracking
Post-Study Evaluation & Feedback
- Lessons learned meetings or debriefs
- Investigator satisfaction surveys
- Study metrics for departmental review