The CRC's role in the safety reporting chain
Define the CRC's specific safety reporting responsibilities and the critical boundaries between the CRC, investigator, sponsor, and IRB roles.
Five people, 24 hours, and the chain starts with you
It is Friday at 4:47 p.m. The coordinator's phone rings. A participant enrolled in a Phase III trial is calling to report that she was admitted to the hospital the previous night with chest pain. She is stable now, speaking from her hospital bed, but she wants the study team to know.
In the next 24 hours, five people must act. The coordinator must gather the initial details and begin documentation. The investigator must provide a medical assessment of seriousness and causality. The sponsor must receive the initial report within the timeline specified in the protocol. The IRB must be notified per institutional policy. And the participant herself must be monitored and, if necessary, have her consent re-evaluated in light of new safety information.