End Notes

End notes are used to give complete information about response data without interrupting the formatting or flow of the CRF Data Section of the PDR. The End Note section, if present, is placed immediately after the CRF Data Section.

There are four types of information that may be included in the end notes of reports that are run: investigator comments, long data values, discrepancy details and audit history. If any of the four types of ancillary data are associated with a data point, a superscript is inserted adjacent to the field. The superscripts start at "1" for each CRF and increment regularly for each field with ancillary data. In the Ancillary Data section, all end notes for a data point are grouped together under the referenced superscript.

• Investigator Comments: If an Investigator comment is associated with a datapoint, the entire content of each Investigator comment is viewable.
• Long Data Values: Response data values that exceed the length of the response field in the CRF PDF are displayed in their entirety in the Ancillary Data section. The exception is responses to questions of type Extended Text.; see Extended Text.
• Discrepancy Details: If an active discrepancy is associated with a response, and you have elected to include discrepancy details in your report, all such details can be viewed in the Ancillary Data section under the referenced superscript.
• Audit History: If a response has been updated, and you have requested that Audit History be included in your report, the complete audit history for that field can be viewed in the Ancillary Data section under the referenced superscript. This section contains the same information as the standalone report; see Audit History Report.