If the sponsor has their own facility for conducting phase I Clinical Trials and the PI is employee of the sponsor Does the monitor has any role in monitoring?
LW: Yes. If the sponsor has it’s own Phase I facility, the PI is not functioning in the capacity of the sponsor, but as an independent PI. All of the usual monitoring activities must occur as if the Phase I facility was an independent entity. The level of documentation and scrutiny is the same. CHP: Sponsors do have units especially for Phase I studies and mostly the PI is an employee of the Sponsor (who still acts independently) regarding subject safety. That sponsor will also have a QA and QC group who will insure that the data are ALCOA. These persons act as if internal ‘monitors’. OK?
