Versions Compared

Old Version 67

changes.mady.by.user Christine Connolly

Saved on

compared with

New Version 68

changes.mady.by.user Christine Connolly

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

...

  1. Using the root variables and other CDASH metadata in the CDASH Model, add any additional variables that are needed to meet the requirements of data collection.

    1. Follow Appendix

    B

    1. x, CDISC Variable-naming Fragments

     conventions

    1. conventions, and CDASH root variable-naming conventions where they exist (e.g., --DAT for dates, --TIM for times, --YN for prompts, as described in the CDASH Model)

    . 
    Example: Replace "--" with the 2-character domain code that matches the other variables in the same domain

    1. .

    For example, to add the --LOC variable to a Medical History CRF, the domain code is MH, so the variable would become

    1.  

    MHLOC in that domain.

    2. The Question Text and Prompt columns in the CDASH Model metadata provide different variations in the recommended text for asking the question on a CRF. For each question, the sponsor may elect to either use the Question Text or the Prompt on the CRF. Some text is presented using brackets [ ], parentheses ( ), and/or incorporating forward slashes. These different formats are used to indicate how the Question Text or Prompt may be modified by

    the sponsor.

    1. The text inside the brackets provides an option on the verb tense of the question, or text that can be replaced with protocol-specific verbiage.

    2. The text inside the parentheses provides options (e.g., singular/plural), or text that may be eliminated.

    3. Text separated with a forward slash provides optional words that the sponsor may choose.

      Example: The CDASH variable --PERF, from the CDASH Model, has the following Question Text and Prompt.

      Question Text:  [Were any/Was the] [--TEST/ topic] [measurement(s)/test(s)/examination(s)/specimen(s)/sample(s)] [performed/collected]?

       Prompt:  [--TEST/Topic] [Measurement(s)/Test(s)/Examination(s)/Specimen(s)/Sample(s)] [Performed/Collected]?

      The sponsor wants to add a question to a CRF that asks whether a lab specimen was collected, using a Yes/No response.

      The sponsor selects the CDASH variable --PERF and adds the appropriate domain code. LBPERF  

      Use either the Prompt or the Question Text on the CRF.

      Question Text: Was the laboratory specimen collected?

    4. In the first set of brackets, the text option "Was the" is selected, as the study required only 1 lab test to be performed. [Were any/Was the] 
    5. In the second set of brackets, the text used is "laboratory," which is the topic of interest. [--TEST/Topic (laboratory)]
    6. In the third set of brackets, the text option "specimen," without the optional "s," is selected. [measurement(s)/test(s)/examination(s)/specimen(s)/sample(s)]
      7. In the fourth set of brackets, the text option "collected" is selected

      .

       [performed/collected]

      Prompt: Laboratory Specimen Collected

      •  In the first set of brackets, the text used is the topic of interest (i.e., laboratory). [--TEST/Topic (Laboratory)] 
      • In the second set of brackets, the text option "specimen," without the optional "s," is selected. [Measurement(s)/Test(s)/Examination(s)/Specimen(s)/Sample(s)]
      • In the third set of brackets, the text option "collected" is selected. [Performed/Collected]
  2. Create custom domains based on 1 of the General Observation Classes in the CDASH Model. See Section 3.4, How to Create New Data Collection Fields When No CDASHIG Field Has Been Defined, for more information.

Creating New Fields

When creating a new data collection field, determine whether the data will be used for an operational use case, such as data cleaning, or are actual data to be represented in a tabulation dataset. In general, new data collection fields (not already defined in the CDASH Model) will fall in one of following categories:

...

Metadataspec
NumField CategoryTarget Tabulation VariableImplementation
1Data CleaningNAThe field --YN with Question Text "Were there any [interventions/events/findings]?" can be used for this purpose. Replace the two dashes (--) with the two-character domain code and create the Question Text or Prompt using generic Question Text or Prompt from the CDASH Model as a base. Always create custom data-cleaning/operational variables using consistent naming conventions.
2Direct MappingYesIf a value can be collected exactly as it will be reported in the tabulation dataset (i.e., same value, same data type, same meaning, same controlled terminology), the tabulation variable name will be used as the data collection variable name in the operational database to streamline the mapping process. Extensions may be appended if needed to create a unique variable name in the collection database. Any collection variable whose meaning is the same as tabulation variable will align with tabulation variable and the meaning will not be modified for data collection.
3

No Direct Mapping


Yes

If a value cannot be collected in alignment with the tabulation dataset variable (e.g., collected data type is different from the data type in the corresponding tabulation variable) or if the tabulation variable is derived from the collected value, then the operational database should use a collection variable with a different name from tabulation variable into which it will be mapped.

No

If a field does not align with a tabulation variable, a unique name should be assigned based on applicant business rules using CDASH naming fragments (e.g., --DAT, --TIM) as appropriate and CDISC variable naming fragments, found in Section x.Appendix x, CDISC Variable-naming Fragments, where possible. 

...