A Continuing Review (CR) application is started from the Protocol Details page. To start a Continuing Review, select process type ‘Continuing Review’ from the dropdown box located to the left of the ‘Create New Process’ button. The ‘Create New Process’ button will launch the Continuing Review initial questionnaire. Any user with edit or manage access to the protocol in Insight will have the ability to start a new Continuing Review on a protocol.
More than one Continuing Review cannot be pending for the same protocol at the same time so the system will prevent this from happening. If a Continuing Review on a protocol has already been submitted and is pending approvals, another user would be able to start another Continuing Review for the same protocol but is prevented from submitting it. Under this condition if a user tries to submit the following error will occur upon clicking the “Submit” button:
When starting a new Continuing Review, the initial form will be presented when the Study Type is selected. Select the Study Type by clicking the appropriate radio button and click the ‘Continue’ button to move to the next page. The next page presented is the Continuing Review form which must be completed and saved.
Once the study type has been selected and the initial questions have been answered and saved, the user is returned to the Forms page where the Continuing Review form can be reviewed and modified, if necessary, and then submitted.
The Forms page consists of a grid with 2 columns. The first column is the Continuing Review form which can be modified if answers were completed incorrectly. The name of the form is qualified with the Continuing Review type (i.e. Continuing Review – Research Data Repository). The ‘Last Modified’ column will show the date and time that the answers on a specific form were last updated.
A Continuing Review can be submitted with or without electronic attachments. To add an attachment, move to the Attachments page. When all changes have been made, navigate to the Submission page to complete the validation and submission process.
Screenshot: Continuing Review Study Type Selection page
Note: Please see the sections in the User Guide for information on Attachments and Validation & Submission.
View Application – Presents the user with a PDF version of the application, which includes all the questions and answers from the Continuing Review form, the list of study staff for the current approved protocol, and the list of any attachments that were uploaded as part of the Continuing Review process.
View Full Application – Presents the user with a PDF version of the application, which includes all the questions and answers from the Continuing Review form, the list of study staff for the current approved protocol and the list of any attachments that were uploaded as part of the Continuing Review process. Also included are any electronic attachments uploaded for the Continuing Review process.
Add / Delete Forms – This is disabled as it is not used for Continuing Reviews.
Delete Application – this allows the submitter or anyone with ‘Manage’ access to the protocol to delete the Continuing Review application. There will be a warning message when this button is selected. Once the application is deleted, it is no longer accessible through Insight.