Openwater Safety Data Collection Template

	B	C	D	E	F	G	H	I	J	K
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2	Openwater Safety Monitoring Data Collection Template
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4	Table 1: Enrollment by Month of Study
5	Month	# Expected	# Screened	#Enrolled or Randomized	# Withdrawn	# Actual	# Cumulative
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14	* Enrollment can also be displayed graphically in a figure, with cumulative subject accrual plotted over time.
15	** Actual = Enrolled - Withdrawn, Cumulative = Sum of Actual by month
16	Table 2: Demographics
17	Characteristics	N	N%
18	Gender
19	Female
20	Male
21	Ethnicity
22	Hispanic or Latino
23	Not Hispanic or Latino
24	Unknown
25	Age
26	Mean (SE)
27	Median (min, max)
28	Race
29	AIAN
30	Asian
31	Nat Hawaiian/Other Pac Islander
32	Black or African American
33	White
34	Other
35	More than one race
36	Unknown
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38	Table 3. Subject Status
39	Pt Identifier	Date Enrolled	Date Completed Study	Study Status	Reason for Withdrawal	% Adherence to Intervention	Intervention Duration (Weeks)
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48	Status
49	A = Active
50	C = Completed
51	W = Withdrew
52	L = Lost to follow-up
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54	Table 4. Adverse Events (AE)
55	Pt Identifer	AE Onset	AE End	AE Code (MedRA CTCAE)	Severity	SAE? (Y/N)	Relatedness	Action Taken	Outcome	Comments
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63	Severity of AE
64	1 = Mild	2 = Moderate	3 = Severe	4 = Life Threatening of disabling
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66	Relatedness to intervention
67	0 = definitely unrelated	1 = unlikely	2 = possibly related	3 = probably related	4 = defininitely related
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69	Action Taken
70	0 = None	1 = dose modification	2 = medical intervention	3 = hospitalization	4 = intervention discontinued	5 = other
71			(specify in comments)
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73	Outcome
74	1 = resolved	2 = recoved with minor sequeiae	3 = recovered with major sequeiae	4 = continuing treatment	5 = condition worsening	6 = patient death **
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76	** Provide further details regarding all reported serious AEs and deaths in the SAE and Subject Deaths tables at the end of this section
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