Understanding Protocol Management

The Protocol Management architecture has two levels: header and version. There is a header level and a child version level. Header information remains static regardless of the many modifications, reviews, or renewals that the protocol undergoes in its full life cycle. Version information may change frequently; therefore, copy version functionality is necessary to avoid manually reentering data into the next version as well as to retain history. The distinction between these levels enables maximum flexibility in copying versions and in tracking changes between versions, which is essential to protocol management.

A protocol undergoes a series of phases during its life. The system captures phases at the version level through the phase type. A protocol moves from one phase to the next by way of version creation. Only one version can govern at any one time and is considered the current version. By viewing the versions in relation to one another on the version grid, you can determine the history and flow of the protocol life. Phases and versions follow these rules:

• The system creates the initial, new protocol header with a version of phase type New and status of Draft.

  You cannot add or copy versions at this stage.

• When you submit the protocol version, the status changes to Approved.

This table describes the protocol management statuses:

The version level status reflects the status for the entire protocol (for example, header) as only one version governs at any given time. Carrying the status at the version level allows for maximum flexibility when you are creating the various phase type protocol versions.

The phase type enables you to track the submissions and re-submissions of the various phases of the protocol. A phase type, along with the status, helps identify which phase the protocol is in. The phase types are:

• New: Indicates a brand new protocol version.

  This is the first phase.

• Modified: Indicates changes or updates being made to either:

  An approved protocol version, which is initiated by the Principal Investigator (PI) (for example, a minor amendment).

• Continuing Review: Indicates a scheduled review of how the protocol research is progressing.

• Renewal: Indicates updates to the approved protocol so the protocol is renewed or extended.

  You can copy a protocol nearing its end date to a new version and reenter a new start and end date.

  Note: You can also create a new protocol ID for this purpose. By copying a version, however, you have the advantage of retaining the link with the previous approved protocol period and header.

This table shows the rule set for how the phase type and status, along with other fields, interact and change the state of the protocol: