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 in 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 | Implementing 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 used 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. |
7 | Presenting 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 of a validated instrument. In some cases, this may result in 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. |