Status & Dates

The Status & Dates section displays the most basic identifying and status information about the protocol. The information is populated automatically after initial save of a new protocol document.

Figure 633 Protocol Document, Protocol Page, Status & Dates Section Example

Table 270 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: Protocol #1008008306 represents year 2010 (10) in the month of August (08) and sequential number 008306

For renewals, amendments, and FYIs, the system assigns a suffix to the protocol number. The protocol submissions for each type are numbered consecutively. The first renewal will be assigned the suffix R001, the next R002, and so on; amendments and FYIs are numbered similarly (A001, A002, etc.; F001, F002, etc.).
Using the protocol example above, the protocol number of the first amendment would be 1008008306A001, the first renewal would be 1008009306R001, and the first FYI would be 1008008306F001.

This is not the same as the Document Id. Use the Protocol number when communicating with the HSO about your study.

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 does not change with the approval of any subsequent submissions for the protocol.

Initial Submission Date

View-only. The date the document was submitted for review. Generated on Initial Submission. Displayed in mm/dd/yyyy format.

The initial submission date does not change through the life of the protocol.

Protocol Status

View-only. Displays the current state that the document is in, as a result of the last action taken. States include:

Active - Open to Enrollment

Abandoned

Active - Closed to Enrollment

Active - Data Analysis Only/

Administratively Closed

Amendment in Progress

Closed by Investigator

Deferred

Deleted

Disapproved

Exempt

Expired

FYI in Progress

Renewal in Progress

IRB review not required

Pending/In Progress

Provisionally Approved

Return to PI

Submitted to IRB

Suspended by DSMB

Suspended by Investigator

Suspended by IRB

Tabled

Terminated by IRB

Withdrawn

Last Approval Date

View-only. The date the protocol was most recently re-approved through the renewal process. Generated by the system upon a renewal approval action. Displayed in mm/dd/yyyy format.

Amendment and FYI approvals do not change this date.

Expiration Date

View-only. Generated by an approval action, this is the last day of the current approval period and changes as a result of a renewal approval action. Displayed in mm/dd/yyyy format.

Amendment and FYI approvals do not change this date.

A user with the IRB Administrator role is able to edit the Initial Submission Date, Approval Date, Last Approval Date, and Expiration Date using the Administrative Correction functionality. These changes are tracked in the audit trail.