Steven D. Chernausek, MD

Research Safety Advisor

Protecting the safety of individuals participating in clinical studies is the very most important responsibility of GCRC researchers and team members. The Research Safety Advisor (RSA), guides the GCRC in this effort. The RSA assures that all GCRC studies are implemented in such a way as to:

• Protect study participants’ safety, confidentiality, and research rights
• Adhere fully to IRB approvals and guidelines in the ethical conduct of clinical research
• Preserve the validity and integrity of research data

To assure these protections, GCRC team members:

• use strategies to enhance study participant protections in GCRC studies
• keep up-to-date with evolving human subjects’ protection standards
• monitor and report adverse events
• help study participants understand their rights and work through possible issues that can arise in the research

Dr. Chernausek represents the interests of study participants and communicates safety issues and recommendations to investigators, the IRB, and the GCRC Advisory Committee. He helps researchers develop data and safety monitoring plans (DSMP), and advises on ways to assure that:

• study procedures adhere to IRB and GCRC Advisory Committee approvals
• studies are implemented according to approved DSMPs
• adverse events and unanticipated problems are reported appropriately and in a timely manner
• educational offerings to improve study participant protections are provided to study participants, researchers, trainees, and team members
• the GCRC makes the best use of problem solving strategies for human research protections issues

The GCRC promotes optimal study participant safety, research ethics, and data integrity by following instructions detailed in each study’s approved DSMP that:

• Names a safety contact
• Delineates criteria used to assess study risk
• Identifies anticipated adverse events
• Conveys plans and assigns responsibilities for ongoing safety monitoring and reporting
• Details how data security and accuracy are assured
• Defines study endpoints

DSMP requirements are listed in the GCRC protocol application packet and a template that incorporates the required elements is available for investigators. Before each study starts, GCRC staff prepare instructions and procedures to ensure that its DSMP is fully implemented. While each study is being conducted, Dr. Chernausek supervises ongoing DSMP study monitoring activities that reflect the study’s risk level, initiates actions to improve problematic areas identified during monitoring activities, and offers advice to study participants, research personnel, and investigators when critical issues arise and counsel is sought.

Contact Steven D. Chernausek, MD, at (405) 271-2767