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 | _________________ |
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