For Physicians & Clinicians
The goal of the Baton Rouge General Clinical Trials Office (CTO) is to assist both new and experienced investigators with industry-sponsored and investigator-initiated clinical research.
Clinical investigators involved in human research are responsible for the oversight of the clinical research according to an IRB approved protocol, Good Clinical Practice (GCP), and all applicable regulations. Investigators are also responsible for protecting the rights, safety and welfare of participants enrolled in a trial and control of investigational product (drugs or devices). The staff in the CTO are trained and experienced in conducting clinical trials and assist investigators in meeting their obligations. The Principal Investigator is responsible for the clinical research activities at the investigative site however, the CTO staff is in place to support the principal investigator with all aspects of study management.
Services offered to investigators coordinating industry funded studies through the CTO include:
- Pipeline services for identifying possible clinical trials
- Site selection and feasibility assessment
- Budget development and negotiation, facilitate contract negotiations and execution, financial billing compliance, financial tracking and management
- Logistical considerations and planning, study start up and staff training
- IRB preparation and submission, IRB amendments, adverse events, annual reviews
- Regulatory document compilation and maintenance
- Design of source documents and case report forms
- Patient recruitment, screening, consenting and follow-up
- Liaison with pharmacy for drug administration, dispensing and accountability
- Phlebotomy and specimen processing and storage
- Data management services (data collection, data entry, query resolution)
- Study close out and archive
In addition to industry-funded studies, the CTO can also assist physicians in developing a clinical research protocol with sound scientific design.