Module D: Regulatory Reports and Audits
X440.8 (2 semester units in Public Health)
A required course in the Professional Program in Clinical Research Conduct and ManagementThis is the final course module in the Professional Sequence in Clinical Research Conduct and Management. It describes the processes of writing, finalizing, and submitting clinical study reports (CSRs) and developing and submitting new drug applications (NDAs). Other topics include regulatory audits and inspection of sponsors, CROs, and investigational sites, and regulations governing electronic records and electronic signatures.
Prerequisites: Module A: Introduction to Clinical Research, Module B: Clinical Trial Planning and Preparation, and Module C: Clinical Trial Initiation and Implementation.
There are currently no sections open for enrollment.
Sections closed for enrollment
Sat. April 26, San Francisco
KAREN HENRY, M.P.H., has held the roles of manager of data management, statistician, trial monitor, trial manager, manager of SOP development and clinical trials training, and instructor. Her participation has been in all phases of drug, biologics, and diagnostic trials in various therapeutic areas, and on the side of the sponsor and investigator. Her past employment has been with New York State Psychiatric Institute/Columbia Presbyterian Medical Center, UC San Francisco Medical Center, Berlex Laboratories, and Chiron Corporation. She currently works for a start-up company as manager of clinical operations. She holds a master's of public health in biostatistics from Columbia University.
- 3 meetings
- April 26: Sat., 9 am-1 pm (no meetings May 3, May 17, and May 24); also
May 10: Sat., 9 am-2:30 pm
May 31: Sat., 9 am-4 pm
- San Francisco: Room 804, UC Berkeley Extension Downtown Center, 425 Market St., 8th Floor (enter on Fremont St.)
- $1,250 (EDP 403212)
Courses begin every month. A new edition of our catalog is published
three times a year in early April, July and December.