Status & Dates

The Status & Dates section displays the most basic identifying and status information about the protocol. The information appears in the six fields after initial save of a new document. Below is an example image of this section with the fields populated, followed by a table that describes each field.

Figure 1104 Protocol Document, Protocol Page, Status & Dates Section Example

Table 320 Protocol Document, Protocol Page, Status & Dates Section Field Descriptions

Field	Description
Protocol #	View-only. Generated on Save. 10 digits. The first two digits represent the year the initial protocol record was created. The next two digits represent the month the initial protocol record was created, and the next six digits represent the sequential order in which the protocol record was created. For example: 0801003756 year 2008 of the month of January 01 and sequential number 003756. The system also assigns a suffix to continuing review/continuation (hereinafter referred to as renewals) and amendments. The renewals and amendments are numbered consecutively. The first renewal will be assigned the number R001, the next R002, and so on. Amendments are numbered similarly, assigning numbers to amendments as A001, A002, A003, etc. This is not the same as the Document Id.
Initial Approval Date	View-only. The date the protocol was first approved. Generated on approval through protocol actions and committee meeting minutes. Displayed in mm/dd/yyyy format. This date is not changed by the approval of an amendment or renewal. Alerts you to supplementary information that is useful to the completion of a task. Replace this text with your note text.
Submission Date	View-only. The date the document was submitted for review. Generated on Initial Submission. Displayed in mm/dd/yyyy format. The submission date is not changed when a renewal or amendment is submitted.
Protocol Status	View-only. Displays the current state that the document is in, as a result of the last action taken. States include: Pending/In Progress, Submitted to IRB, Specific Minor Revisions Required, Amendment in Progress, Renewal in Progress, Active - Open to Enrollment, Active - Closed to Enrollment, Active - Data Analysis Only, Exempt, Closed Administratively for lack of response, Closed by Investigator, Suspended by Investigator, Withdrawn, Expired, Disapproved, Terminated by IRB, Suspended by IRB, Not Human Subjects Research, IRB review not required, and Suspended by DSMB.
Last Approval Date	View-only. The date the protocol was most recently re-approved through the continuing review (renewal) process. Generated by the system upon a renewal approval action. Displayed in mm/dd/yyyy format. An amendment approval does not change this date.
Expiration Date	View-only. Generated by an approval action, this is the last day of the current approval period, and does not change due to a renewal approval action. Displayed in mm/dd/yyyy format.

A user with the IRB Administrator role is able to edit the Submission Date, Initial Approval Date, Last Approval Date and Expiration Date records for administrative correction purposes, which are tracked in the audit trail.