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• All HR (Highly Recommended) and applicable R/C (Recommended/Conditional data collection ) fields are present in the CRF and/or operational database. 

• Specified controlled terminology must be used to collect the data in the CRF. All codelists displayed in the CRF must use or directly map to the current published controlled terminology submission values, when it is available. Subsets of published CT, such as those provided in CDASH terminology, can be used.

• The design of the CRF follows recommendations in Section x.x, Creating Data Collection Instruments and Section x.x,
•  CRF Design. Update links

• Specified Question Text or Prompts must be used to ask the question per associated guidance.

• Variable naming conventions should be included in the operational database as specified in this guide.

Data output by the operational database into a tabulation dataset variable should requires no additional processing if the CDASH and SDTM variable names are the same. 

1. 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.

1. his must be followed to maintain the validity of a validated instrument. (See Section 8.3.12, QRS - Questionnaires, Ratings, and Scales).
   1. 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.
   2. The use of such questionnaires in their native format should not be considered to affect conformance to CDASH.