How are changes in study personnel handled?

If the SMART IRB Standard Operating Procedures (SOPs) are used, study teams from Relying Institutions will first report proposed changes in personnel to the Point of Contact (POC) at their institution, following their institution’s established procedures and policies.

The POCs at Relying Institutions must authorize submissions involving changes to a Site Principal Investigator (PI) or key personnel, in order to ensure these personnel meet the Relying Institution’s requirements.

Once authorized by the local SMART IRB POC, the Relying Site Study Team will coordinate with the Lead Study Team, who is responsible for submitting amendments to the Reviewing IRB for review in accordance with the Reviewing IRB’s policies and procedures. This includes study-wide and local amendments.