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 1201 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 1202 Protocol Document, Protocol Actions Page, Summary & History Section - Summary - 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 1203 Protocol Document, Protocol Actions Page, Summary & History Section - Summary – 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 1204 Protocol Document, Protocol Actions Page, Summary & History Section - Summary – 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: If a protocol with an Adverse Event form and Informed Consent form was returned for revisions and the investigator added a new HIPPA Form during the protocol revision, the current sequence of the protocol will show 3 protocol attachments.

 

Figure 1205 Protocol Document, Protocol Actions Page, Summary & History Section - Summary – Current Sequence Attachments

 

 

          The previous sequence of the protocol will only show the Adverse Event and the Informed Consent forms.\

 

         

 

         

Figure 1206 Protocol Document, Protocol Actions Page, Summary & History Section - Summary – Previous Sequence Attachments

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 Specific Minor Revisions, Substantive Revisions Requested, Return to PI and Withdraw.