Summary

 

The Summary subsection displays the key identifying information about the Protocol document, consolidating pertinent information from other pages of the document into categories.

Figure 930 Protocol Document, Protocol Actions Page, Summary & History Section - Summary Subsection Example

 

Protocol Versions (Sequences)

The information displayed in the Summary is organized by protocol versions or sequences. By default the Summary displays key protocol information of the current sequence of the protocol.

 

•      Sequence Number: The system indicates which sequence is currently being displayed and the total number of sequences using the following notation  . The first digit in   indicates the current sequence of the protocol that is being displayed. The second digit in  indicates the total number of sequences that have been created for the protocol.

 

               Figure 931 Protocol Document, Protocol Actions Page, Summary & History Section, Summary Subsection - Sequences

 

•      Prior and Next Sequence: The user can use the previous and next buttons to navigate to all protocol sequences. To view the protocol summary of a prior protocol sequence, click on  button displayed on the header of the Summary panel. 

Figure 932 Protocol Document, Protocol Actions Page, Summary & History Section, Summary Subsection – Sequences – Previous Sequence

To return back to the more current sequences of the protocol click on the  button displayed on the header of the Summary panel.

Figure 933 Protocol Document, Protocol Actions Page, Summary & History Section, Summary Subsection – Sequences – Next Sequence

 

•      Attachment versions: The system maintains and displays protocol and personnel attachments within each sequence. If between subsequent protocol versions, attachments have been changed, added or deleted, the user can go to the particular protocol sequence to view the exact state of the attachments in that protocol version.

[Sample scenario: An attachment is added as part of the protocol resubmission by the investigator. Since the system versions the protocol upon resubmission by the investigator, sequence 2 of the protocol will show the added attachment. Sequence 1 will not have the attachment.]

 

         

 

         

 

 

A sequence of the protocol is created only when the protocol is returned to the investigator after initial submission. Some of the protocol actions that can create sequences are Minor Revisions, Major Revisions, Return to PI and Withdraw.