ABCDEFGHIJKLMNOPQRSTUVWXYZAA
1
Instructions to Users
2
This exceptions request forms is completed by program leads or administrators for the purpose of allowing exceptions to core fields in the ARGO data dictionary. This request forms part of the Clinical Data Exceptions section of the Quality Standards of Samples and Clincial Data Policy. Please consult the policy for more detail on the exceptions process. Please submit fully completed forms to the Clinical and Metadata Working Group Coordinator where all requests will be reviewed. Please Contact Us if you have questions relating to this form.
3
ItemInstructionExample
4
1Make a copy of the ghseet or download the spreadsheet for an independant copy. Please do not edit the original form. File-> make a copy, or File-> download excel .xslx
5
2Please use a new row for each exception request. You must answer all the questions for each individual field request
6
3Tab 1 is to be completed for PROGRAM LEVEL exceptions, tab 2 for DONOR LEVEL exceptions. If you only need exceptions on specific donors use the DONOR LEVEL sheet to submit. You must use a new line for each Donor ID.
7
4Note the exceptions only apply to CORE (mandatory) fields, Fields labelled extended do not require exceptions (optional)
8
5Ensure the form is fully completed before submission to allow for swift review
9
6Please use the drop down menus in each column where provided and avoid free text in these
10
7requested_exception_value: please enter the value you propose for the exception using standard and acceptable language (this is what will be displayed on the portal). Acceptable values are provided below. Please contact us if you wish to discuss an alternative value for this column.
11
Permissable Value Definition
12
UnknownA value that would be meaningful for analysis if observed, but is not available.
13
Not applicableThe determination of the value is not relevant in the current context. (Reference NCIt C48660)
14
Cannot be assessed/determinedAspects of the context prevent the evaluation needed to determine a value. (Reference NCIt C48657)
15
8Rationale_for_exemption_request: please provide details on why the exception is required. See right for an exampleExample: This is not reported in most patients at time of pathological assessment.
a separate specmimen is assessed which contains metastatic disease or a met is found within resected tissue , it remains not reported (or reported as MX).
16
9Following submisison of your expcetions request it will be reviewed by the Clincial and Metadata Working Group. Correspondance will be providing following review.
17
10
For DONOR LEVEL (individual) exceptions, please ensure you submit the requiste ID (donor_ID, Specimen_ID or treatment_ID relevant to your request to enable to placement of the exception to the correct file.
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
61
62
63
64
65
66
67
68
69
70
71
72
73
74
75
76
77
78
79
80
81
82
83
84
85
86
87
88
89
90
91
92
93
94
95
96
97
98
99
100