Regulatory requirements of clinical research (IRB, GCP, HIPAA, and investigational filings), ensuring patient safety, interactions with government and industry, contract negotiations, successful strategies and tactics.
Prerequisites: None
Credit: 1 hour; required
Grading Criteria: Pass/Fail; Students are expected to attend each class, to do the assigned reading, and to participate in classroom discussions. A take-home final exam will be due at the last session.
Semester: Summer
Course Director: Suzanne Rivera, PhD, Assistant Vice President for Research Services (B6.204), phone: 214 648-0455, fax: 214 648-2119
Course Administrator: Mack Dressler, Dept. of Clinical Sciences (E5.506)
phone: 214 648-2558, fax: 214 648-3934
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