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
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
Standards for Analysis
conformance rules