Critical Sign-Off and Certification

 

The first step in the workflow of a protocol application is the certification and sign-off by the Principal Investigator and any Site Responsible Investigators staffed to the study as well as the Department Chair(s) of each staffed PI.  The protocol will not progress to the next steps until all critical study staff has completed the sign-off process.

 

The certification form itself is composed of three parts.

 

1)  The header component contains information specific to the submission, such as protocol title and assigned protocol number if available.

2)  Contains standard text describing the statements being certified.

3)  The signature section provides the date and time the certifier’s electronic signature was authenticated and captured.

 

Principal Investigator Sign-off

When an application is submitted, an e-mail notification is sent to the primary staffed PI(s) indicating that they have a workflow task in Insight.  The e-mail will provide a hyperlink to the Insight activity so that the PI can logon to review the protocol, view and complete the certification form screen, sign-off electronically using NT authentication and add comments when appropriate.  Once the primary staffed PI has completed sign-off, the Site PI(s) will be notified and proceed through the same sign-off process. 

 

These are the steps to completing the certification review and sign-off on-line:

 

Screenshots:  Principal Investigator Certification and Review

 

Click on the link in the “Type” or the “Action Required” column:

 

 

Check the boxes next to each true statement:

 

 

Authentication (Electronic Sign-Off):

 

 

Accept or Decline:

 

Department Chair Sign-off

The next step in the workflow of a submitted application is the approval of the Department Chair(s) and IRB Chair if the institution is NWH, SRH or NSMC.  Department Chairs sign-off only required for new protocols that are human intervention or interaction studies.  Non-intervention limited studies do not require sign-off by a Department Chair. 

 

Routing to the Department Chair is based on the institution and department / unit of the PI and Site PI.  The Insight system maintains a relationship of PI’s to Department Chairs.  Alternate chairs can be identified which take the place of the regularly established Department Chair. 

 

If there are multiple PI’s assigned to the protocol, and they are associated with different departments, then sign-off by each associated Department Chair is required. 

 

These are the steps to completing the certification review and sign-off on-line:

 

Screenshots:  Department Chair Review

 

Click on the link in the “Type” or the “Action Required” column:

 

 

Review the statements and click the appropriate box (acceptable or not acceptable):

 

 

Authentication (Electronic Sign-Off):

 

 

Accept or Decline: