Clinical Research for the Principal Investigator

This course is customized to introduce Principal Investigators of the academia and those working for industry-sponsored clinical trials on how to successfully conduct clinical trials at the investigators site. All requirements are reviewed and real cases scenarios are presented to allow the participant understand compliance to regulatory requirements, communication to ethics boards and their responsibilities.

Course Overview

This workshop provides principal investigators with formal training in Clinical Research and Development. The topics are selected to fulfill a learning need that is not provided by any institution or sponsor of clinical trials. This course and workshop takes into account practical issues that can be learned and applied immediately. The entire program is designed to help physicians learn how to review clinical trial protocols for potential implementation with safety and effectiveness purposes; discriminate ethical and medical practice issues before a contract agreement is signed and an institutional review board is approached, and further explain all the regulatory implications of running clinical studies together with clinical practice.

The purpose of this workshop is to:

  • Introduce Medical Investigators to the issues of running compliant clinical trials
  • Present the Drug Development Process
  • Explain the Monitoring and Regulatory Inspection/Audit Process

Course Outline

The following topics will be discussed in response to the question:

What a Medical Investigator should know before starting an industry or investigators sponsored clinical study?

  • Good Clinical Practices and FDA/ EU/ Health Canada Regulations concerning Clinical Trials
  • FDA Investigators responsibilities
  • IRB/ERB, Financial Disclosure (US), Patient Information and Consent forms and process, Drug Development Process
  • Confidentiality, delegation of authority
  • Clinical Trials Documents: the protocol, the consent form, the investigators brochure, the case report forms
  • Electronic systems in clinical research
  • Clinical Study Audit (internal, regulatory audit)
  • Response to an FDA 483 and Warning letters
  • Obligations under contract agreement vs. Ethics and Medical Practice
  • The sponsor/investigator, IND application process
  • Clinical Trials Registration - News

Who Should Attend

This two-day course is valuable for all participants with daily responsibilities in the following areas:

  • Physicians 
  • Medical Specialists
  • Surgeons
  • Any other Medical Professional who plans to participate or presently runs Clinical Trials 


CERTIFICATE OF ATTENDANCE AND COURSE MATERIAL

Upon Completion of the course: 

  • CME: 12  Elective credits by the American Academy of Family Physicians will be available to qualifying participants and
  • All participants will receive a Certificate of Attendance
  • Also, after completion of the course, participant may decide to take a comprehension exam. If the exam is passed successfully, participant will receive the Certificate of Completion  (CertCRP Certification).