Clinical Trials

clin trial

As a Clinical Trials Office, PoRCH aims to serve as a centralized resource for investigators, study staff and departments involved in clinical trials research. It also serves as a centralized point of contact for sponsors seeking to conduct pediatric clinical trials at the University of Florida.

A clinical trial is “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.“


Getting Started

Feasibility Review
Needs Assessment
Recruitment Plan
Budget Negotiation
Coverage Analysis & Billing Plan
Submit Studies to OCR & IRB
Regulatory Document Preparation

Activation

Screening & Recruitment
Community Outreach
Patient Enrollment
Coordinate Patient Visits
Data Collection & Management
Regulatory Maintenance

Ongoing

Study Team Hiring & Training
Study Team Professional Development
Routine Quality Assurance Checks
Study & Safety Reporting
OnCore Reporting
Financial Reporting