What is a clinical project?
A. A clinical project is one in which the project investigators have direct contact with patients having the disease or condition of interest. Normal healthy subjects may be included, but only in combination with patients. In studies involving the use of human specimens, the investigators must have direct interaction with the patient from whom the specimen is obtained and relate the research results to the patient status or outcome for this to be considered a clinical project. It is intended that the requirement for investigator interaction with the study participants will eliminate research involving archived tissue. Q: An investigator can obtain samples from patients enrolled in a clinical treatment trial being conducted by industry in order to measure pathogenic markers that will be evaluated with respect to individual patient outcome. Does this qualify as a clinical project? A: No. If the investigators are not involved as a site in the clinical study, this would not be considered a
