A Kaplan EduNeering course

This course will introduce you to regulations and guidelines that oversee the process of laboratory sample collection and shipping of human specimens for clinical research use in the United States. 

After completing this course, you will be able to identify the rules and regulations that apply to laboratory samples, recognize how a sponsor utilizes the services of a central laboratory, how a principal investigator utilizes a local laboratory, and identify the sponsor and investigator site responsibilities for collection of specimen, as well as specimen packaging for shipping.  In addition, you will be provided with compliance resources to ensure that sponsors and investigator sites maintain compliance with mandatory regulations.

Topics include:
      ·          Clinical laboratories
      ·          CLIA certification
      ·          Sponsor role
      ·          Site Responsibility and Documentation
      ·          Medical waste disposal
      ·          Packaging and transport of specimens

Linda Belmont at DIA