CRF Creation

This section appears if you request Audit History when you generate the report. It includes:

• Created By: The user account that performed the first Save on the entered CRF, whether saved as Complete or Incomplete.
• Role of that user
• Timestamp of that CRF creation

When combined with field-level audit history, the complete history for each field can be constructed, with the caveats noted below.

• For responses initially saved as null, while the CRF is in status Pass1 Started or Entry Started, the time a response changed from null to not null is not available. Once the CRF is saved Complete, field-level audit histories include an entry for the change from null to not null.

• If optional DCI and DCM header fields like Comment are not entered with initial data entry, the times these fields changed from null to not null values are not available.

• If a DCM is marked Blank with the initial save, and responses are subsequently entered, the times these responses were entered after the blank flag is unchecked are not available.

  However, the Blank Flag history itself indicates the time the blank flag is unchecked. It can be assumed that at least one, if not all responses would have been entered at that time. Further, assuming the document is saved Complete at this time, subsequent changes of other fields from null to not null values is reported as part of the audit histories for those fields.