| 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) |
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| * 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) |
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| | | | Participant did not meet all inclusion/exclusion criteria (2) |
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| | | | Specimen(s) collected without documentation of approval (6) |
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| | | | Other, specify: (97) (Go To: 1107) |
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| * 1107 | Type of protocol deviation (Other, specify): (Go To: 1097) |
| 1097 | Comments (do not include any participant identifiers) (Go To: End of Form) |