What Studies Must Involve the CRS?
Any clinical study which is regulated by a State or Federal agency, such as Phase I-IV human studies or pivotal target animal efficacy studies that a Sponsor intends to submit data to the Food and Drug Administration or Department of Agriculture.
Are All Clinical Studies Managed by the CRS?
No. Certain studies, such as retrospective chart reviews, case reports, or certain types of investigator initiated trials may not be managed by the CRS.
What Research Does Not Involve the CRS?
Basic (bench) research, retrospective chart reviews, case reports, or lab animal studies.