291 Campus Drive
Stanford, CA 94305
USA
Course Fee: $65
Course Eligible for BRN Credit
(Clinical Research Operations Program elective)
The mission of the Stanford Center for Clinical Research (SCCR) includes offering educational resources, training, and support for investigators and research staff. We have invited Savita Sinha, MS, clinical research consultant and instructor in the UCSC Extension Certificate Program in Clinical Trials Design and Management, to provide you with a solid foundation in successful clinical trial monitoring. This lecture will present the essential elements of monitoring a clinical trial as well as the interactions between a sponsor and one or more sites during a clinical investigation. Expectations of the FDA, sponsor and site will also be presented.
At the conclusion of this class, you will be able to:
- Understand tasks to be completed before, during and after a monitoring visit
- Examine compliance audits and fraud and misconduct
- Evaluate the importance of accurate data entry and product accountability
- Interpret expectations of the FDA, sponsor and clinical site
Attendance is open to all research staff but seating is limited to 30.
Registration for this course is through STARS (activity code SCCR-5062) and you may use your STAP funds. If you have any questions, please contact Kiera Larsen at klarsen5@stanford.edu.
About the Instructor:
Savita Sinha, MS, obtained her Master of Science degree in microbiology from the University of Bombay, India. She also completed a graduate study in management from St. Thomas University in Miami, FL. She has immense experience in all aspects of clinical operations, trial management and monitoring. She has worked as a clinical research consultant for the past 20 years, managing multi-center, global phase II, phase III and post-marking studies. She has also presented and conducted multiple training sessions at investigator meetings and served as a mentor for CRAs. She has also worked as a Clinical Research Associate II, monitoring phase I-IV trials, including multi-center trials. Currently, she is an instructor in the UCSC Extension Certificate Program in Clinical Trials Design and Management, specializing in clinical trial monitoring.
BRN OPTIONAL
Spectrum Stanford Center for Clinical and Translational Education is an approved provider by the California Board of Registered Nursing, Provider Number CEP15435 for 4.0 contact hour(s).
To receive your certificate with BRN credit, you are required to complete an evaluation at the conclusion of this class.
BRN Cancellation Policy: If you wish to cancel your registration, please DROP this class in STARS within 7 days of the course date or notify Kiera Larsen at klarsen5@stanford.edu to receive a refund.