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For data collection using CRFs, conformance to standards is minimally indicated ensured by:
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| Num | Conformance | Adherence |
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| 1 | Following TIG Core designations are followed. | All HR (Highly Recommended) and applicable R/C (Recommended/Conditional) data collection fields are present in the CRF and/or operational database. | | 2 | Guidance Following guidance for CDISC Controlled Terminology is followed. | Controlled terminology is used as specified to collect the data in the CRF. | | 3 | Best Following best practices for CRF design are followed. | The design of the CRF follows both recommendations for creating data collection instruments and recommendations for CRF design. | | 4 | Standard Implementing standard wording for Question Text or Prompts is implemented. | 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 are followed. | Data Collection Variable conventions are used in the operational database as specified. | | 6 | Data Aligning data collection variables values and target tabulation variables values are alignedwhen 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. | | 7 | CRFs used to collect data for validated questionnaires, ratings, or scales present the Presenting validated QRS questions and reply choices as validated in the CRF. | his must be followed All QRS questions and reply choices are presented as validated in the CRF to maintain the validity of a validated instrument . (See Section 8. 3.12, QRS - Questionnaires, Ratings, and Scales). In some cases, this may result in CRFs that CRFs that do not conform to CDASH best practices; however, restructuring these questionnaires should not be done because it could invalidate them. The The use of such questionnaires in their native format should not be considered to affect conformance to CDASH. |
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Guidelines for Tabulation Datasets
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