CDASH examples include both metadata tables and sample case report forms (CRFs). Each table of CDASH metadata corresponds to an example annotated CRF (aCRF), built directly from the metadata. The annotations show the variables associated with each field in the context of data collection (CDASH) and submission (SDTM); the applicable context is denoted by color. Data that are collected using the same variable name as defined in the SDTMIG are in RED. If the CDASHIG variable differs from the one defined in the SDTMIG, the CDASHIG variable is in GREY. Data collected but not submitted in SDTM-based datasets are denoted as NOT SUBMITTED
The following diagram illustrates how to interpret the annotations.
When viewing sample aCRFs, bear in mind that:
- Example CRFs are provided to illustrate data collection instruments. They are only examples and are not meant to imply that any particular layout is preferable to another.
- Example CRFs are best understood in conjunction with their respective metadata tables and/or the CDASH Domain Metadata Tables.
- Most example CRFs do not include the Highly Recommended header variables. The population of these values is usually determined by the sponsor's data management system.
- Sponsors are responsible for understanding and implementing CDISC Controlled Terminology where applicable.