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Metadataspec
NumConformanceImplementation
1Following 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.

2Following guidance for CDISC Controlled Terminology.

Controlled terminology is used as specified to collect the data in using the CRF. 

3Following best practices for CRF design.

The design of the CRF follows both recommendations for creating data collection instruments and recommendations for CRF design.

4Implementing 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.

5Following 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 the collection and the tabulation variable names are the same.

Data output by the operational database into a tabulation dataset variable requires minimal processing when the data collection variable and the 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.

7Presenting validated QRS questions and reply choices as validated in the CRF. 

All QRS questions and reply choices are presented as validated in the CRF to maintain the validity. 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 should not be considered to affect conformance to CDASH.

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