Clinical Trial Investigator Development Course: Building Excellence in Clinical Research Practice

 

This course is designed for physicians who intend to participate in or lead research activities at Baptist Health South Florida. It provides essential training on research compliance, institutional requirements, regulatory standards and best practices for conducting ethical and responsible research within BHSF.

Upon completion of this course, physicians will understand the institutional processes necessary to initiate research, the responsibilities of investigators and the documentation required prior to engaging in research activities.

Technical Support

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Continuing Medical Education Department
Office Hours: Monday - Friday, 7:30 a.m. - 3:30 p.m.
Excludes federal holidays. Appointments only.
Phone: 786-596-2398

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Target Audience

Baptist Health Medical Group Physicians and Medical Staff who serve as research investigators at Baptist Health in all the therapeutic areas. 

Learning Objectives

Upon completion of this conference, participants should be better able to:

  • Apply ethical and regulatory principles to protect human subjects and ensure compliant conduct of clinical research
  • Design, conduct and manage clinical studies using evidence-based research methods and operational best practices
  • Demonstrate competency in data management, analysis, collaboration and quality assurance to support reliable, transparent and ethical research outcomes
Additional information
Bibliography: 
  • Aggarwal, R., & Ranganathan, P. (2019). Study designs: Part 4—Interventional studies. Perspectives in Clinical Research, 10(3), 137–139.
  • Bhatt, A. (2010). Evolution of clinical research: A history before and beyond James Lind. Perspectives in Clinical Research, 1(1), 6–10.
  • Brawley, O. W. (1998). The study of untreated syphilis in the Negro male. International Journal of Radiation Oncology, Biology, Physics, 40(1), 5–8.
  • International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2025). Guideline for good clinical practice E6(R3).
  • Joint Taskforce for Clinical Trial Competency. (n.d.). Clinical trial competency framework.
  • Junod, S. (n.d.). FDA and clinical drug trials: A short history. U.S. Food and Drug Administration.
  • Lader, E., Cannon, C., et al. (2004). The clinician as investigator: Participating in clinical trials in the practice setting. Circulation, 109(21).
  • Miracle, V. (2016). The Belmont Report: The triple crown of research ethics. Dimensions of Critical Care Nursing, 35(4), 223–228.
  • Nagai, H., Nakazawa, E., & Akabayashi, A. (2022). The creation of the Belmont Report and its effect on ethical principles: A historical study. Monash Bioethics Review, 40(2), 157–170.
  • Office of the Secretary, The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979). The Belmont Report: Ethical principles and guidelines for the protection of human subjects of research.
  • Ranganathan, P., & Aggarwal, R. (2018). Study designs: Part 1—An overview and classification. Perspectives in Clinical Research, 9(4), 184–186.
  • Ranganathan, P., & Aggarwal, R. (2019). Study designs: Part 3—Analytical observational studies. Perspectives in Clinical Research, 10(2), 91–94.
  • Tobin, M. J. (2022). Fiftieth anniversary of uncovering the Tuskegee syphilis study: The story and timeless lessons. American Journal of Respiratory and Critical Care Medicine, 205(10), 1145–1158.
  • U.S. Food and Drug Administration. (n.d.). Code of Federal Regulations Title 21 (Parts 50, 54, 56, 312, 812).

 

Course Summary
Available credit: 
  • 2.00 AMA PRA Category 1 Credit™
  • 2.00 General certificate of attendance
Course opens: 
05/08/2026
Course expires: 
05/07/2027

Draco Forte, MEd, CHRC, CCRP
Director, Research Operations & Quality Assurance
Baptist Health Research
Baptist Health South Florida 

Draco Forte, MEd, author of this educational activity, and Scott Lipkin, M.D., conference director, have no relevant financial relationships with ineligible companies* to disclose, and have indicated that the presentation(s) or discussion(s) will not include off-label or unapproved product usage.

Non-faculty contributors and others involved in the planning, development, and editing/review of the content have no relevant financial relationships with ineligible companies* to disclose. 

*Ineligible companies - Companies whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients.

Disclosure Policy and Disclaimer

Baptist Health South Florida is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. Baptist Health has been re-surveyed by the ACCME and awarded Commendation for 6 years as a provider of CME for physicians.

Baptist Health South Florida designates this enduring material for a maximum of 2.0 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Available Credit

  • 2.00 AMA PRA Category 1 Credit™
  • 2.00 General certificate of attendance
Please login or register for a Baptist Health CME account to take this course.

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Technical Support
Technical Support

If you are experiencing technical difficulties or have received an error message, please send an email to [email protected] and include a print screen of the error message, your browser name and version, username and URL where the error occurred. You can expect a response within 48 hours.