RESEARCH TIPS

This new column is devoted both to sharing new information and reminding investigators of regulatory requirements and best practices in research. 

This Month’s Subject—Good Clinical Practice

Did you know?

• Good Clinical Practice (GCP) regulations were established in response to events that cast doubt on the validity of some clinical trials.




• GCP regulations are the quality standard to be used during the conduct of clinical trial studies.




• GCP’s became effective 5/9/1997.




• GCP’s offer an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects.




• GCP Compliance provides public assurance that the rights safety and well-being of trial subjects are protect consistent with the principles that have their origin in the Declaration of Helsinki.




• Principals of this guideline may also be applied to other clinical investigations that may have impact on human subjects.

For Further Information

Please contact the Human Research Protection Program (HRPP) or the Institutional Review Boards (IRB) at 794-4356 for further information, or with questions on this or any other topic related to the conduct of human subjects research. 

Additional Resource

Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance (FDA, 1996)