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This is an example CRF used to collect the subject's eligibility.   

Example CRF:  Inclusion/Exclusion 

 

Panel

Example CRF Completion Instructions

  • All procedures must be performed and the subject’s eligibility determined within <protocol-specified time period prior to study medication administration>.
  • (If applicable, include the following instructions) Complete the Inclusion/Exclusion Worksheet as source document by recording a “Yes” or “No” response to each criterion.
  • Record the criterion identification that was an exception. 

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This is an example of SDTM dataset that represents data collected on a protocol inclusion/exclusion CRF. The IECAT column uses the controlled terminology EXCLUSION, or INCLUSION.  IETEST and IETESTCD are defined in the TI domain.   

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