Form:	Canary: PASS Protocol Deviation v3.0

CDE ID	CDE Description
* 421	EDRN Participant ID (Go To: 2642)
* 2642	Date of protocol deviation (MM/DD/YYYY): (Go To: 423)
* 423	EDRN Protocol ID (Go To: 422)
* 422	EDRN Site ID (Go To: 929)
* 929	EDRN Staff ID of the person who collected the data: (Go To: 2176)
2176	Visit code (Go To: 1105)
	Permissible Values (value): Baseline (19)
	Y1V06 (20)
	Y1V12 (21)
	Y2V06 (22)
	Y2V12 (23)
	Y3V06 (24)
	Y3V12 (25)
	Y4V06 (26)
	Y4V12 (27)
	Y5V06 (28)
	Y5V12 (29)
	Y6V12 (51)
	Y7V12 (53)
	Y8V12 (55)
	Y9V12 (57)
	Y10V12 (59)
* 1105	Date site learned of protocol deviation (MM/DD/YYYY): (Go To: 2175)
* 2175	Type(s) of protocol deviation(s): (Check all that apply.) (Go To: 1097)
	Permissible Values (value): Participant did not sign a consent form (1)
	Participant did not meet all inclusion/exclusion criteria (2)
	Specimen(s) collected without documentation of approval (6)
	Other, specify: (97) (Go To: 1107)
* 1107	Type of protocol deviation (Other, specify): (Go To: 1097)
1097	Comments (do not include any participant identifiers) (Go To: End of Form)