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In this section, conformance refers to whether implementation of standards per this guide meets the requirements of the standards. Conformant collection and representation of tobacco product study data is ensured by full adherence to standards per this guide. Conformance to standards is assessed by confirming implementation of standards per this guide and by evaluating tabulation and analysis data in relation to conformance rules.

For data collection using CRFs, conformance to standards is minimally indicated by: 


NumConformanceAdherence
1TIG 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.

2Guidance for CDISC Controlled Terminology is followed.

Controlled terminology is used as specified to collect the data in the CRF. 

3Best practices for CRF design are followed.

The design of the CRF follows both recommendations for creating data collection instruments and recommendations for CRF design.

4Standard 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.

5Data Collection Variable naming conventions are followed.

Data Collection Variable conventions are used in the operational database as specified.

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 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.

7CRFs used to collect data for validated questionnaires, ratings, or scales present the questions and reply choices as validated. 
  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.



Guidelines for Tabulation Datasets

Tabulation dataset conformance with standards in this guide is minimally indicated by:

  • Representation of all collected, assigned, and relevant derived data in applicable datasets.
  • Following the complete metadata structure for data domains
  • Following SDTMIG domain models wherever applicable
  • Using specified standard domain names and prefixes per controlled terminology where applicable
  • Using specified standard variable names
  • Using specified standard variable labels
  • Following SDTM-specified controlled terminology and format guidelines for variables, when provided
  • Including all Required and Expected variables as columns in standard domains, and ensuring that all Required variables are populated
  • Ensuring that each record in a dataset includes the appropriate Identifier and Timing variables, as well as a Topic variable
  • Conforming to guidance in CDISC Notes column and general and domain-specific assumptions
  • Conformance Rules





Conformance to standards in this guide can be proactively ensuring


and assessing conformance Conformant collection and representation of data is ensured by full adherence standards per this guide.



Conformance may be by data collection







Conformance to standards may be minimally assessed by confirming intended implementation per the guidelines below and by evaluating tabulation and analysis datasets in relation to conformance rules.


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