This is an example CRF used to collect the protocol milestone, informed consent.
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.
Record Yes if all eligibility criteria were met at the time the subject was enrolled. Record No if the subject did not meet all criteria at the time the subject was enrolled. | Were all eligibility criteria met? IEYN Not Submitted | <NY codelist> | |
---|---|---|---|
Record whether the criterion exception was Inclusion or Exclusion. | What was the category of the criterion? IECAT | <IECAT codelist> | |
If the subject was not eligible, record the identifying code for each criterion that was an exception. | IETESTCD | _________________ |
This is an example of data that was collected on a protocol inclusion/exclusion CRF. The IECAT column uses the controlled terminology EXCLUSION, or INCLUSION. IETEST is the free text description from the protocol., and IETESTCD are generally of the form INCL00n or EXCL00n. The trial design domain TI, is used to describe the criteria. One record for each of the inclusion and exclusion criteria for the trial are included in TI . This domain is not subject oriented.
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