Table 1.

Typical “Core” and “Additional” responsibilities of the CRC.

Core CRC Responsibilities	Additional CRC Responsibilities
· Adherence to an IRB approved protocol	· Submissions to regulatory authorities (e.g., IRB, FDA, etc.)
· Participation in the proper consenting of study subjects	· Regulatory documentation development and management
· Support of the safety of clinical research subjects	· Completion of case report forms (paper & electronic data capture)
· Coordination of clinical treatment, study visits, and follow‐up care	· Coordination of pre study, initiation, and monitoring visits
· Subject screening, recruitment, and enrollment	· Collection, processing, and shipping of laboratory specimens
· Maintenance of study source documents	· Maintenance of drug accountability documentation
· Proper reporting of adverse events	· Study budget preparation
	· Management of study finances including resolving study subject billing issues
	· Acting as liaison for research subject, investigator, IRB, sponsor, and healthcare professionals