| 1 | Adherence to 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 | Adherence to specified use of Guidance for CDISC Controlled Terminology is followed. | Specified controlled Controlled terminology must be is used as specified to collect the data in the CRF. |
| 3 | 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 | Adherence to Standard wording for Question Text or Prompts is implemented. | The wording of CRF questions is standardized per specified Question Text or Prompts are used to standardize the wording of CRF questions. for the data collection fields. |
| 5 | Adherence to Data Collection Variable naming conventions are followed. | Data Collection Variable conventions are used in the operational database as specified in this guide. |
| 6 | Data collection variables values and target tabulation variables values are aligned. | Data output by the operational database into a tabulation dataset variable requires minimal processing when the data collection variable and tabulation variables names are the same. should requires no additional processing if the CDASH and SDTM the tabulation variable names are the same. - An SDTM data programmer should be able to assume that data in an SDTMIG variable is SDTMIG-compliant. Minimal processing (e.g., changing case) does not affect conformance. This helps to ensure a quality deliverable, even if the programmer is unfamiliar with data capture practices.
should requires no additional processing if the CDASH and SDTM variable names are the same. - An SDTM data programmer should be able to assume that data in an SDTMIG variable is SDTMIG-compliant. Minimal processing (e.g., changing case) does not affect conformance. This helps to ensure a quality deliverable, even if the programmer is unfamiliar with data capture practices.
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 | 7 | Validated questionnaires, ratings, or scales present the questions and reply choices as validated. | - his must be followed 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 do not conform to CDASH best practices; however, restructuring these questionnaires should not be done because it could invalidate them.
- The use of such questionnaires in their native format should not be considered to affect conformance to CDASH.
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