The Standard Operating Procedures (SOPs) in this library have been established to ensure consistency and compliance with Federal & State regulations, institutional policies, and Good Clinical Practice guidelines that are common to clinical research of all types. By standardizing these SOPs, we are aligning our clinical research activities across campus with the 1U4U vision.
The SOPs in this library define clinical research and clinical trial as:
CLINICAL RESEARCH (CR): Clinical research includes all research involving human participants. It does not include secondary studies using existing biological specimens or data collected without identifiers or data that are publicly available.
|CLINICAL TRIAL (CT): Clinical trials are clinical research studies involving human participants assigned to an intervention in which the study is designed to evaluate the effect(s) of the intervention on the participant and the effect being evaluated is a health-related biomedical or behavioral outcome.|