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.
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.
Baton Rouge General provides investigators with training in the ethical
and regulatory requirements that govern human research. These computer-based
training programs are required by the IRB and federal law to participate
in human subject research.
The principal investigator will ensure that all personnel associated with
a study are trained and certified for completion of human studies research.
In the event that the certification lapses for any study personnel, he/she
may not continue participation in the study until certification is renewed.
CITI Program training: www.citiprogram.org
IRB Manager is the software service we use to manage all information related
to studies. Please contact the IRB Administrator at (225) 387-7112 for
login information if you plan to be an Investigator/Coordinator.
Becoming a Principal Investigator
Being involved in clinical trials enables physicians to learn and become
exposed to new medical therapies. The PI is responsible for the clinical
research activities at the investigative site however, the CTO staff is
in place to support the PI with all aspects of study management.
Physicians interested clinical research opportunities at Baton Rouge General
should contact the Clinical Trials Office at (225) 237-1674 or email