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Education and Training Offerings

Clinical Trials Training Course (7 hours)

This course is designed to supplement the required SCRIHS training and is intended for research staff and investigators who have limited formal training in clinical trials. The content will be useful to anyone involved in clinical research and will provide an introduction to clinical trial conduct, Good Clinical Practices (GCPs), and sponsor-investigator relationships.

Course Content:

1. Introduction to Clinical Research

  • History

  • Clnical Trial Design

2. Responsibilities of Research Team

  • Investigator

  • Coordinator

  • Sponsor

3. Conducting the Study

  • Managing Study Documentation

  • Informed Consent

  • Source Documentation

  • Case Report Form Completion

  • Study Drug/Device Accountability

  • Evaluating and Reporting Adverse Events

  •  Protocol Deviations and non-Compliance

  •  Sponsor Monitoring Process

4. Learning from Others with Q &A

Good Clinical Practice Training Course (3 hours):

The program and content is designed to provide clinical research education relating to Good Clinical Practice (GCP). GCP sets the standards for the design, conduct, monitoring and reporting of clinical research. This course is offered quarterly and space is limited.  This course is designed to facilitate CITI’s online GCP training and is intended to educate individuals involved in all phases of clinical research. Compliance with GCP provides regulators assurance that data are reported, results are credible and accurate, and that all rights, safety, confidentiality, and well‐being of trial subjects are protected.

Course Content:

  • Overview of New Drug Development

  • International Conference on Harmonization (ICH): GCP Requirements

  • FDA Regulated Research

  • International Conference of Harmonization, ICH for Investigators

  • Conducting Investigator‐Initiated Studies According to FDA Regulations and GCP

  • Investigator Obligations in FDA‐Regulated Clinical Research

  • Managing Investigational Agents According to GCP Requirements

  • Conducting Clinical Trials of Medical Devices

  • Informed Consent

  • Detection and Evaluation of Adverse Events

  • Reporting Serious Adverse Events

  • Audits and Inspections in Clinical Trials

  • Monitoring of Clinical Trials by Industry Sponsors

Clinical Research Orientation (12 hours):

Includes eight 1.5 hour training sessions. These sessions include training on clinical research, human subject protection, source documentation, IRB responsibilities, industry sponsored studies, study start up to close-out, time management, and working in the hospitals.

Clinical Research Methods (22-28 hours):

Includes twelve 2 hour training sessions. These sessions include training on clinical research, the research process, research questions,  critical review of research articles, gathering the literature & electronic database search, qualitative & quantitative research, study designs, data analysis, research findings, and developing a clinical research project proposal.

Research Educational Opportunities

1 Hour Lecture Topics

  • CCR STATS 101: Explanation of Journal Statistics

  • Clinical Research: What-Why-How

  • Stats and Diagnostic Testing

  • Basic Stats and Research Design

  • Clinical Epidemiology Terms and Use

  • Is it Research or Is it Quality Improvement

  • Evaluating Processes or Outcomes of Care Using National Databases

  • Writing Case Reports

  • Bioethics Human Experimentation

Other SIUSOM Education:

  • Human Subjects Research Training – Online CITI module (SCRIHS)

  • Conflict of Interest Training – Online CITI module (SCRIHS)

  • Responsible Conduct in Research Workshop (8 weeks offered every other year)

  • Grant Writing Workshop (8 weeks offered every other year)

  • Using Software that Supports Research: An Introduction to the Statistical Package for the Social Sciences (SPSS and Altas.ti)

Research educational opportunities and training courses are available upon request by your department chair.