Each study staff member is required to certify and sign-off on their workflow task after the HRO has reviewed and accepted the application.
These are the steps to completing the certification review and sign-off on-line:
Study Staff Review – click Accept or Decline to acknowledge participation in the study.
Study Staff Certification – click all checkboxes to certify compliance, enter username and password, and then click the ‘Authenticate’ button to complete the electronic sign-off.
Comment (optional) – enter comments if necessary and click the ‘Accept’ or ‘Decline’ box to complete the task.
Study staff members assigned to the protocol is expected to sign-off before final board approval. Omission of any non-critical staff signatures does not hold up the workflow process. If any study staff members do not sign-off before final IRB approval, they will be removed from the protocol before it is approved and active. Any dropped study staff can be added after the protocol is active through submission of an amendment.
When an application is submitted, notification emails are sent to staff members in that they need to complete and submit certification forms. The e-mail will provide a hyperlink to the Insight activity so that the users can logon to review the protocol, accept or decline participation in the study and complete the certification form screen and sign-off electronically using NT authentication. Staff members will be able to complete and submit their certification forms without guidance from a central coordinator.
For certification to be complete, the staff member verifies that the information the system has displayed on the certification form is accurate. If the submission has inaccurate data (for instance the staff member may have been assigned an incorrect role), then the staff member should decline the certification step with a note so that the issue can be corrected. When the certification form meets the staff member’s approval, the staff electronically signs the certification and submits it.
Screenshots: Study Staff Review and Certification task
Click on the Protocol Number or Protocol Title link
Check the boxes next to each true statement
Authentication (Electronic Sign-Off)
Accept or Decline: