CCNCR Services

About Our Services

The CCNCR provides participating researchers within the Department of Pediatrics with a variety of services related to the implementation and conduct of clinical trials and research studies. These services include, but are not limited to:

• Participant recruitment and enrollment: Identifying eligible study participants and ensuring their informed consent.
• Study coordination: Overseeing the logistics and organization of the research study, including scheduling visits and procedures for participants.
• Data collection and management: Accurately recording participant data and maintaining study databases.
• Regulatory compliance: Ensuring the study follows all ethical guidelines, regulations, and protocols.
• Institutional review board (IRB) submissions: Preparing and submitting study protocols and amendments for IRB approval.
• Communication with participants: Keeping participants informed about the study progress and addressing their concerns.
• Investigational product management: Handling the administration and storage of study drugs or devices.
• Adverse event reporting: Monitoring and reporting any adverse events experienced by participants during the study.
• Quality control and assurance: Implementing measures to maintain data accuracy and study integrity.
• Collaboration with study sponsors: Maintaining communication with study sponsors or pharmaceutical companies.
• Study close-out: Ensuring all study-related materials are appropriately archived and completing necessary documentation.
• Training and education: Providing education and training to study staff and investigators on study protocols and procedures.
• Budget management: Assisting in managing the study budget and tracking expenses.
• Site monitoring visits: Hosting and facilitating visits from sponsor representatives or monitors.
• Compliance with Good Clinical Practice (GCP) guidelines: Adhering to GCP standards for conducting clinical research.

Service Cost

All of the services offered will require a fee for service.  Fees are dependent on the complexity of the study, number of visits, and type of support (nursing, data management etc). A summary of costs will be provided after feasibility has been approved by CCNRC and prior to initiation of services.