Usually, only applicable data collected in alignment with regulatory needs should be collected on the CRF, due to the cost and time associated with collecting and fully processing the data. However, some fields on a CRF may be present to support electronic data capture (EDC) functionality
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showSummary | false |
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server | Issue Tracker (JIRA) |
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serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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key | TOBA-438 |
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and/or review and cleaning of data through automated edit checks.
The protocol (and SAP, when it is prepared in conjunction with the protocol) should be reviewed to ensure that the parameters needed for analysis are collected and can be easily analyzed. The statistician and/or principal investigator is responsible
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showSummary | false |
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server | Issue Tracker (JIRA) |
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serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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key | TOBA-704 |
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for confirming that the CRF collects all of the data necessary to support the analysis.