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CRF Standardization Process

vinny avatar
vinny
3 diapositives · 193 Views · Sep 06, 2014

CRF Standardization Process. CRF Question Partition Categories Mandatory: A data collection variable that must be on the CRF (e.g., a regulatory requirement (if applicable)). Must be used. Conditional:

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CRF Standardization Process
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  1. CRF Standardization Process • CRF Question Partition Categories • Mandatory: • A data collection variable that must be on the CRF (e.g., a regulatory requirement (if applicable)). Must be used. • Conditional: • A data collection variable that must be collected on the CRF for specific cases that may be dictated by local or sponsor defined business rules. • Optional: • A data collection variable that is available for use if needed. Usually collected due to the design of the protocol, like in instances where marital status or educational level are important indicators in a study.   • Non-harmonized: • A data collection variable that is, by consensus, to primarily belong to a different CRF module or is not belonging to any defined module. CRFs

  2. CRF Standardization Process • CRF Question Partition Categories • Mandatory: • A data collection variable that must be on the CRF (e.g., a regulatory requirement (if applicable)). Must be used. • Conditional: • A data collection variable that must be collected on the CRF for specific cases that may be dictated by local or sponsor defined business rules. • Optional: • A data collection variable that is available for use if needed. Usually collected due to the design of the protocol, like in instances where marital status or educational level are important indicators in a study.   • Non-harmonized: • A data collection variable that is, by consensus, to primarily belong to a different CRF module or is not belonging to any defined module. Content coming in from the community that is already in caDSR

  3. CRF Standardization Process • CRF Question Partition Categories • Mandatory: • A data collection variable that must be on the CRF (e.g., a regulatory requirement (if applicable)). Must be used. • Conditional: • A data collection variable that must be collected on the CRF for specific cases that may be dictated by local or sponsor defined business rules. • Optional: • A data collection variable that is available for use if needed. Usually collected due to the design of the protocol, like in instances where marital status or educational level are important indicators in a study.   • Non-harmonized: • A data collection variable that is, by consensus, to primarily belong to a different CRF module or is not belonging to any defined module. Content coming in from the community that is not in caDSR