Evolution Research Group (ERG) Principal Investigator Training

Monday, February 17, 2025, 3:00 AM - Monday, February 16, 2026, 11:59 PM


AMA PRA Category 1 Credits™ (20.00 hours)

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.

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.

 

The University of Miami Leonard M. Miller School of Medicine designates this Enduring Material for a maximum of 20.00 of AMA PRA Category 1 Credits^TM. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Accessibility Statement
 
University of Miami Healthcare System is committed to ensuring that its programs, services, goods and facilities are accessible to individuals with disabilities as specified under Section 504 of the Rehabilitation Act of 1973 and the Americans with Disabilities Amendments Act of 2008.  If you have needs that require special accommodations, including dietary concerns, please contact the CME Conference Coordinator.

Mitigation of Relevant Financial Relationships

The University of Miami adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Education. Any individuals in a position to control the content of a CE activity, including faculty, planners, reviewers or others are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant conflicts of interest have been mitigated prior to the commencement of the activity.