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| Metadataspec |
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| Num | Conformance | Implementation |
|---|
| 1 | Following TIG Core designations. | All HR (Highly Recommended) and applicable R/C (Recommended/Conditional) data collection fields are present in the CRF and/or operational database. | | 2 | Following guidance for CDISC Controlled Terminology. | Controlled terminology is used as specified to collect the data using the CRF. | | 3 | Following best practices for CRF design. | The design of the CRF follows both recommendations for creating data collection instruments and recommendations for CRF design. | | 4 | Following standard wording for Question Text or Prompts. | The wording of CRF questions is standardized per specified Question Text or Prompts for the data collection fields. | | 5 | Following Data Collection Variable naming conventions. | Data Collection Variable naming conventions are applied in the operational database as specified. | | 6 | Aligning data collection variables values and target tabulation variables values when collection and tabulation variable names are the same. Minimal processing, such as changing case when mapping a data collection variable value into a tabulation variable, does not affect conformance. | Data output by the operational database into a tabulation dataset variable requires minimal processing when the data collection and tabulation variable names are the same. | | 7 | Presenting validated QRS questions and reply choices as validated in the CRF. In some cases, this may result in CRFs that do not conform to CDASH best practices. The use of such questionnaires in their native format does not affect conformance. | All QRS questions and reply choices are presented as validated in the CRF. |
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For data collection using CRFs, conformance to standards is minimally ensured by:
Guidelines for Tabulation Datasets
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