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Conformant collection and representation of tobacco product study data is ensured by full adherence standards per this guide. When this is not possible.... At a minimum, the following guidelines must be followed. 

Conformance rules

SEND Conformance Rules are limited to those that are associated with SEND Implementation Guide (SENDIG) 
text.
The following are considered to be outside the scope of SEND Conformance Rules:
• Rules that are not supported by a definitive statement in the SENDIG
• Business rules
• Data validation logic that is not specifically linked to Standard Data Tabulation Model (SDTM) 
implementation guidance
• Rules that check across studies within a submissio

Need to point to conformance rules and note rules will be available at time of Public Review

Guidelines for Data Collection

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