Conducting Clinical Studies Course

The purpose of this course is to provide faculty, clinical research staff, and other health professionals with information on the current standards and regulations for conducting clinical research trials, involving human subjects. The program covers a diversity of topics from federal regulations, protocol evaluation, statistical/data management issues, quality management, considerations for human subjects, institutional requirements and operational strategies. Didactic lectures will be followed by group discussions allowing active participation of attendees.

This is an annual course that is sponsored by the General Clinical Research Center at L.A. Biomedical Research Institute at Harbor-UCLA Medical Center. Determination of needs is based on requests from the institution and from faculty who are involved in the conduct of clinical research. Frequent changes in the regulatory environment and the standards and procedures for the conduct of clinical trials mandate that annually updated information be provided to faculty who serve as clinical trial investigators. In addition, as new faculty join the institution, this course serves to provide the basic education in Good Clinical Practices, which is the cornerstone for conducting clinical research studies.

Following this program, participants will be able to…

Identify and apply Federal Regulations and Good Clinical Practice Guidelines in the conduct of clinical research.

Express an understanding of the biostatistical considerations for conducting clinical studies, including evaluation of study objectives, determination of sample size and power, and understanding study analyses.

Discuss the human subjects issues in the conduct of clinical trials.

Identify elements of a Quality Management Program for the clinical research site.

Discuss the types of clinical trial audits that may occur, the common findings and the possible outcomes.

Identify the steps required to initiate and conduct clinical research studies at L.A. Biomedical Research Institute at Harbor-UCLA Medical Center.

This course does not receive any commercial support. Speakers are faculty members or employees of LA Biomedical Research Institute and are not paid for their participation in this course.