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For data collection using CRFs, conformance to standards is minimally assessed by confirming adherence to the following described in Section x.x, :
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Num | Guidance | Description |
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1 | TIG Core designations , specified in data collection metadata tables, 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 | CDISC Controlled Terminology is used as specified in alignment with this guide,. | - Specified controlled terminology must be used to collect the data in the CRF.
| 3 | Best practices for CRF design are followed. | | 4 | The wording of CRF questions is standardized. | - Specified Question Text or Prompts are used to ask the question per associated guidance.
| 5 | Naming conventions for data collection variables are used in the operational database. | - Variable naming conventions are used in the operational database as specified in this guide.
| 6 | 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. | - 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.
| 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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