Evolution Research Group (ERG) Principal Investigator Training

Evolution Research Group (ERG) Principal Investigator Training is organized by University of Miami Miller School of Medicine Division of Continuing Medical Education.

Start Date: February 17, 2025
End Date: February 16, 2026

Description:
Section 1: Introduction to being a Principal Investigator: At the end of this section, participants will be able to describe the importance of a 1572 signature in terms of responsibility for the conduct of a clinical trial. Procedures for acting as a Principal Investigator is emphasized throughout these lectures.

Section 2: Phases of Clinical Research from Phase 0 to Phase Four: The participant will be able to delineate and analyze each phase of clinical research with respect to the purpose, goals and regulatory requirements. By the end of this section, participants will be able to describe the life of the Investigational Product from laboratory chemistry to the implementation in humans to post regulatory approval as a result of research studies.

Section 3: Clinical Practice vs Clinical Research: Trainees will review and analyze the differences regarding treating patients in a clinical setting versus managing subjects in a clinical research trial. 

Section 4: All the Players: Participants will review and understand the role of different organizations involved in research trials. This includes Pharmaceutical companies, Clinical Research Organizations, Laboratories, ECG vendors and patient advocacy groups. The trainee will understand the importance of these groups as stakeholders and will describe their contribution to the research project. Ethics in Clinical Research is discussed from the Nuremberg Doctors Trial, Thalidomide off label use and the Declaration of Helsinki. Participants will review the structure and mandates of the FDA in addition to ethical considerations in clinical research. 

Section 5: Communication in Clinical Research: Participants will understand the importance of communication and will understand how to communicate effectively. The legal nature of emails will be reviewed and analyzed. 

Section 6: ECG Interpretation in Clinical Research At the end of this section, participants will understand basic ECG reading as it relates to clinical research and will understand clinically significant findings versus non clinically significant findings. 

Section 7: Contraception in Clinical Research: At the end of this section, participants will understand FDA mandates, practical considerations and IP toxicity grading with respect to Clinical Research and contraception. A series of examinations is provided with each of the lectures. Upon satisfactory completion of training a certificate of completion will be issued in addition to CME credit hours.

Objectives:

At the conclusion of this activity, learners will be able to:

• Section 1: Introduction to being a Principal Investigator: At the end of this section, participants will be able to describe the importance of a 1572 signature in terms of responsibility for the conduct of a clinical trial. Procedures for acting as a Principal Investigator is emphasized throughout these lectures.
• Section 2: Phases of Clinical Research from Phase 0 to Phase Four: The participant will be able to delineate and analyze each phase of clinical research with respect to the purpose, goals and regulatory requirements. By the end of this section, participants will be able to describe the life of the Investigational Product from laboratory chemistry to the implementation in humans to post regulatory approval as a result of research studies.
• Section 3: Clinical Practice vs Clinical Research: Trainees will review and analyze the differences regarding treating patients in a clinical setting versus managing subjects in a clinical research trial.
• Section 4: All the Players: Participants will review and understand the role of different organizations involved in research trials. This includes Pharmaceutical companies, Clinical Research Organizations, Laboratories, ECG vendors and patient advocacy groups. The trainee will understand the importance of these groups as stakeholders and will describe their contribution to the research project. Ethics in Clinical Research is discussed from the Nuremberg Doctors Trial, Thalidomide off label use and the Declaration of Helsinki. Participants will review the structure and mandates of the FDA in addition to ethical considerations in clinical research.
• Section 5: Communication in Clinical Research: Participants will understand the importance of communication and will understand how to communicate effectively. The legal nature of emails will be reviewed and analyzed.
• Section 6: ECG Interpretation in Clinical Research At the end of this section, participants will understand basic ECG reading as it relates to clinical research and will understand clinically significant findings versus non clinically significant findings.
• Section 7: Contraception in Clinical Research: At the end of this section, participants will understand FDA mandates, practical considerations and IP toxicity grading with respect to Clinical Research and contraception.