Whats the difference between Clinical Research Site (CRS) Leader and Investigator of Record (loR)?
A. The CRS Leader is the onsite senior research scientist responsible for the administrative and scientific components of the site. The CRS leader is responsible for overall site activities, including the day-to-day operations, performance, and compliance at the site level. The IoR is the individual at the site responsible for ensuring that a specific clinical trial is conducted in accordance with the protocol, applicable U.S. federal regulations, in-country regulations and any provisions imposed by the reviewing IRB/EC/other regulatory entity. This is the person who signs the Form FDA 1572 or the DAIDS IoR Form. Depending on the site, the CRS Leader may or may not be the same as the IoR. If the CRS leader is different from the IoR, the CRS leader should be added as a sub investigator to the Form FDA 1572 or DAIDS IoR Form as appropriate.
Related Questions
- Where to locate a Jewish museum Copenhagen as a site for a Jewish museum What difference does it make where Jewish museums are located within the spatial context of the city?
- In the 4Life® Compensation Plan, what is the difference between a Leader4Life and a Leader?
- What is the difference between Permissions and Licensing on the site?
