CRF Completion Instructions

• Whenever possible, details related to the completion of a single field should be placed with the field itself on the CRF.
• If this is not possible due to the medium and/or system being used to create CRFs, then it is permissible to include the field-level instructions at the top of the form, in what is generally considered the form-level instruction area. In some cases (e.g., form-level instructions are very lengthy or include graphics or flowcharts), a separate CRF completion instruction guideline may be required.

When creating form-level instructions for a CRF, the following should be considered:

• The instructions should include clear references to the time period for which data are to be reported for the study, or to specific time windows that are allowed.
• The instructions should provide references to protocol sections for the specifics of and/or limitations on the data to be reported.
• The instructions should include any special instructions for additional reporting or actions required beyond what is collected on the CRF.
• The instructions should include considerations on how data collected on one CRF might have an impact on data that are reported on a different CRF.
• The instructions should refer to any other forms that are related to the CRF being completed.