PCRO Seminar: Topics in Clinical Research

Pediatric Clinical Research Office

The PCRO Seminar Series is an on-going endeavor that provides thoughtful and important education venues focusing on topics identified during the course of the Clinical Research Quality Assurance and Research Clinical Billing Reviews as well as current topics in clinical research. The purpose of this CME accredited series is to provide a dynamic forum for pediatric faculty and staff engaged in clinical research to:

Learn about and discuss new and practical aspects of clinical research
Continually improve the overall quality and safety of studies conducted within the Department

Topics addressed include:

Informed consent/assent and the informed consent/assent process
Subject recruitment
Enrollment and retention
Ethical issues in human subject’s research
Charting and documentation
Budget preparation and development
Research design
Protocol development
Issues in clinical research and human subject protection
Time and effort reporting
Innovative care versus research
Compliance
Clinical trials finance
Good clinical practice guidelines
Monitoring compliance through quality assurance activities and reviews
Conflict of interest versus conflict of roles/use of vulnerable populations in clinical research.

Individual learning objects are for investigative staff to:

Develop/acquire a better knowledge/understanding of Good Clinical Practices in conducting clinical research
Gain/develop better knowledge of conducting clinical research so as to reduce/eliminate chart deficiencies resulting from Clinical Research Quality Assurance and Research Clinical Billing Reviews towards an overall enhancement in the quality of clinical documentation
Enhance overall knowledge base and research skills of investigative staff in the conduct of clinical research