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Pediatrics / Research / Pediatric Clinical Research Office / PCRO Seminar: Topics in Clinical Research

Topics in Clinical Research

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The PCRO Seminar Series is provided on an as-needed basis and 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 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