CRORS currently conducts training on research related topics for the UM research community. These presentations are given on a regular basis throughout the year.
- CRORS provides the UM research community with CEUs for nurses, social-workers and psychologists (valid for annually attended classes). Additionally, these training hours can be used for research related professional organizations such as ACRP and SOCRA.
- PIs and study teams are encouraged to attend this educational series every year to keep current with regulations, guidances and to maintain and increase their knowledge.
- Customized clinical research training courses for individual departments are also provided upon request.
CRORS Training Courses
The following CRORS Training Courses are available at ULearn:
- Good Clinical Practice – This is a basic course in Good Clinical Practice, which provides an overview of the GCP components and their supporting federal, local and international regulations and guidelines.
- Protocol Compliance – Upon completing this course, the attendees should understand how to achieve, improve and maintain protocol compliance, and prevent, identify and report protocol deviations. The attendees will have a broader knowledge of the underlying federal and local regulations and guidelines and implement preventive measures to avoid protocol compliance issues.
- Principal Investigator’s Oversight of Clinical Study – Upon completion of this course, the attendees should understand what is expected from Principal Investigators with regard to providing and demonstrating appropriate oversight of clinical research activities. The attendees will be aware of the regulatory requirements and the FDA’s “current thinking” in respect to Principal Investigator oversight.
- Regulatory Binder – This course provides an overview of the Regulatory Binder/Trial Master File and the required essential documents. Upon completion of this course, the attendees should understand the purpose of the Regulatory Binder/Trial Master File; how it evolves throughout the study, and the underlying regulations and guidelines.
- Documentation Practices – This course provides an overview of good documentation practices, record retention requirements and supporting federal and local regulations and guidelines.
- Informed Consent Process – Upon completion of this course, the attendees should have a practical knowledge on how the consent process is to be conducted at the University of Miami, with an emphasis on regulatory and administrative requirements.
- Monitoring Process – This course will provide an overview of the FDA requirements of monitoring IND/IDE studies, the importance of selecting qualified monitors, monitoring expectations and the process of preparing for the monitoring visit. Upon completion, attendees will have a better understanding for the reason monitoring is required, the importance of selecting experienced monitors, the role of a monitor, the extent of a monitoring visit and how to be prepared for the monitor.