Table 3.

Student Presentation: System Factors Identified in a Healthy Volunteer Sentinel Event

Systems Identified Case 1	Number of Errors/ Near Misses Identified by Students	Examples	Number of Errors/ Near Misses Identified by Faculty	Percentage Agreement
FDA	1	The FDA was not able to function in a timely way  to respond to queries	1	100
Institutional	2	IRB approval for a drug that was no longer  FDA approved	2	100
Team factors	5	Did not notify IRB of adverse events or discuss  with coinvestigators	7	71
Provider factors	4	Failing to seek supervision from principal  investigator	4	100
Task factors	5	Did not adhere to research protocol	5	100
Patient factors	0		0	100

Abbreviations: FDA, Food and Drug Administration; IRB, institutional review board.