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Metadataspec
ForCategoryGuidance
CRF and System DesignCollection of Dates

  • Implement collection of dates such that individuals involved in data can only record the data to precision collected. 

    • The system should also store only the collected precision.

    • Any incomplete dates must remain incomplete with no imputation and no “zero-filling” of missing components.

    • Data collection and database processes should allow for the possibility of partial dates and times, because a partial date may be the most precise information that can be collected for some data. 

      If a full date is collected (or expected), the CDASH variable --DAT or all 3 date components (i.e., --DATYY, --DATMO, --DATDD) should be included on the collection tool. If a partial date can be collected in a single field, the CDASH --DAT should be used. If a partial date must be collected as separate database fields to collect year, month, and day, refer to the CDASH Model for examples of standard naming fragments (--YY, --MO, --DD, --TIM).

    • The capabilities of individual software systems (e.g., EDC) will determine which variable names are needed. CDASH uses separate data collection fields for dates and times. 

Tabulation Dataset Mapping

Imputation of Dates

The visit date variable (VISDAT) can be applied to all observations for a given visit (if appropriate), or specific date and timing fields may be included for a specific observation in the body of the CRF. When the visit date is used to reflect the timing of an observation, the appropriate timing variable for that tabulation dataset may be populated with the CDASH Visit Date. 

Collection Guidance


This is from best practices - questionnaires and prompts

    • In cases where the data collection is done in a denormalized presentation on the CRF, the relevant CDISC CT should be used in the question text or prompt as much as possible.
    • It is acceptable to use synonym text that will directly map to a CDISC submission value (including an NCI Preferred Term), if the CDISC submission value is not appropriate for data collection. For example, "ALT" may be better than "Alanine Aminotransferase" as the prompt for this lab test. If there is no CDISC CT available, the question text or prompt must be standardized by the implementing organization and used consistently. One of the basic purposes of CDASH is to reduce unnecessary variability between CRFs and to encourage the consistent use of variables to support semantic interoperability; therefore, Question Text and Prompt must be used verbatim. 
  1. Similarly, where SDTMIG variables exist in the operational database and the value conforms to controlled terminology, it is permissible to use a familiar synonym on the CRF without affecting conformance. For example, on the Demographics page, SEX may be displayed as "Male" or "Female", whereas in the operational database the controlled terminology values of "M" and "F" would be used.
  2. In some cases, CDASH Question Text and Prompt allow for flexibility while still being considered conformant. See Section 2.3, CRF Development Overview, for further details on the usage of Question Text and Prompt.
  3. CDASH Model Question Text may contain options for the tense; if the option is not provided, the tense of the Question Text may be modified to reflect the needs of the study.
  4. In cases where the CDASH Question Text or Prompt cannot be used due to culture or language, or a CRF must be translated for language or cultural reasons, the implementer must ensure the translation is semantically consistent with the CDASH Question Text and Prompt in the CDASHIG metadata table.
  5. In cases where a more specific question needs to be asked than that provided by Question Text or Prompt, CDASH recommends the use of a brief CRF Completion Instruction, as long as the instruction clarifies the data required by the study without altering the meaning of variable as defined by the standard. For example, "Sex at birth" is not the same question as "Sex" (which is loosely defined as "reported sex").






Relative Timing Variables (SEE SECTION 3.7)

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