Pamela Richtmyer - Director, MGB Human Research Affairs Compliance & Education
Kathy Vernovsky - MGB Human Research Affairs Compliance & Education
This course is intended for investigators and research staff. A well-written protocol is essential to successful and compliant clinical research. This course will address the following questions:
• What are the required elements of a protocol including GCP requirements?
• What makes a protocol effective?
• What issues related to protocol writing have been identified in regulatory inspection and audits?
• Are there special considerations when writing a protocol?
• What is required for protocol training?