Program Description

Clinical Research / Clinical Science Course

Goal: This course has been established to develop an internationally accepted standard of knowledge and understanding of the research process and related regulations, as well as medical and scientific areas related to clinical research.

Objective: The course contains two modules. 35 hours total CE available. The attendee may elect to attend one (either) or both modules.

Module I is the Regulatory / Procedural Module consisting of sessions pertaining to: Issues Involved in Addressing the Development Process, Clinical Pharmacology and Adverse Event Reporting, Study Development and the Research Budget, Good Clinical Practices, ICH Guidelines, Informed Consent, Preparing for an GCP Audit, Regulatory Affairs and IRBs (IND/NDA), Research Ethics, and Source Documentation and Administration.

Module 1 is a 3 day course which meets Monday 8:00 a.m. - Wednesday 4:30 p.m.

Module 2 is the Medical / Scientific Module. It is focused on Medicine and Science, designed for those who are relatively new to research who wish to strengthen their understanding of medicine and science. Module 2 consists of sessions pertaining to: Ethical Issues in Clinical Trials, Anatomy and Physiology, Cell Biology, Genetics, Clinical Laboratory Analysis, Epidemiology, and Research Statistics.

Module 2 is a 2 1/2 day course which meets Wednesday 1:00 p.m. - Friday 4:30 p.m.

Learning Objectives: Upon completion of this (full) course the attendee should be able to:

  • Discuss the Drug Development Process regarding the definitions, regulations, and processes from IND to NDA.
  • Discuss the development and implementation of the International Council for Harmonisation, the clinical research guidelines resulting from that collaboration, and how the ICH guidelines affect the clinical researcher.
  • Discuss the (drug, device, biologics) development program, including protocol development, case report form design, project and program management, assessing costs and building budgets.
  • Describe adverse drug reactions and adverse events, the drug development process, drug laws, statistical perspectives, specific mechanisms of drug actions, and IRB notifications.
  • Discuss various perspectives and regulations regarding adherence to protocol, patient rights, informed consents, and regulatory issues related to an FDA audit.
  • Discuss procedural and management issues regarding utilization and disposition of source documents
  • Discuss regulations, generally accepted policies and procedures, and audit practices associated with IRBs and the informed consent process.
  • Discuss research ethics including the importance of the informed consent and the principles of medical research ethics as well as therapeutic misconceptions, randomizations, and placebos.
  • Discuss cell biology including cell structure, function, and reproduction.
  • Describe the development and science supporting genetics and pharmacogenetics.
  • Discuss anatomy and physiology including selected body systems, organs, and how they function.
  • Discuss the basic laboratory values in clinical research and their importance in the disease process.
  • Discuss epidemiological and statistical issues related to the distribution and determinants of health related events in certain populations.