Starting a New Protocol Application
A new protocol application can be started from any of the tracking pages which include: Active Protocols, Pending Applications, Work in Progress, Inactive Protocols and Exempt Protocols.
The ‘Create New Protocol’ button will launch the new protocol initial questionnaire. Any user with access to the Humans module in Insight will have the ability to start a new protocol application from any of the tracking pages.
The new protocol initial is a series of questions that will be used to determine which relevant forms of a protocol application to present to the submitter. The user will first enter the full title of the protocol and the sponsor designation/number (if applicable). Next, there is a series of questions that are required to be answered prior to saving the form. When the form is completed click ‘Save’ to navigate to the Forms page. The initial questionnaire is only available when starting a new application. If questions were answered incorrectly, there is a function to customize the application. This is described in more detail below.
Screenshot: Starting a new protocol application
Screenshot: New Protocol Application initial questionnaire
There are different types of studies and each type has its required forms that must be completed. Other forms that are presented to the user are dependent on how the questions in the initial questionnaire are answered.
For example, there are 11 required forms for an Intervention study; these are listed under the header ‘Intervention’ in the Forms grid. The ‘Drugs/Biologics/Dietary Supplements’ header will appear if the user answered ‘Yes’ to the following question on the initial questionnaire.
Note: The Sponsor / Funding form is always required.
Screenshot: Standard Protocol – Forms page
The ‘Last Modified’ column will show the date and time that the answers on a specific form were last updated. The ‘Modified By’ column will display the last user to make an update on the form once it is in progress of being completed.
The following buttons are available on the Forms page:
View Application – clicking this button presents the user with a PDF version of the application, which includes all the questions and answers from the application forms, the list of study staff, and the list of any attachments that were uploaded as part of the application process.
View Full Application – clicking this button presents the user with a PDF version of the application which includes all the questions and answers from the application forms, the list of study staff and the list of any attachments that were uploaded as part of the application process. Also included are any electronic attachments, with the exception of attachment types ‘Response to Review’ and ‘Staff Certification Form’.
Add/Delete Forms – clicking this button presents the user with a page on which the application can be customized. This is described more fully below.
Delete Application – this allows the submitter or anyone with ‘Manage’ access to the protocol to delete the application. There will be a warning message when this button is selected. Once the application is deleted, it is no longer accessible through Insight.
Screenshots: Editing full title or sponsor designation name/number
The protocol Full Title and/or Sponsor protocol designation/number can be modified from this page by clicking on the link above the forms grid (next to ‘Edit’). Clicking the link will bring up a page with editable values for these fields. Click the ‘save’ button to save any changes to these fields and return to the Forms page. Click the “cancel” button to return to the Forms page.
Click “Full title or Sponsor protocol designation/number”:
Enter any changes to the Title or Designation/Number and click “save” or “cancel”:
Application forms can be added or removed after the initial form has been completed by clicking the Add / Delete Forms button from the Forms page. This allows the customization of the application even after the initial application has been completed. If a form is mandatory (i.e. Study Details) there is not an option to 'Add' or 'Delete' the form as it must be completed as part of the application process. On this page the form names are not hyperlinks, as the forms themselves cannot be modified from this screen.
These actions are available for each form directly from this page:
Delete – This permanently deletes a form from an application. There will be a warning pop-up message when clicking on the ‘Delete’ button
Add – This adds a form to an application. This is relevant for forms that may not have been designated as required or for adding additional forms of the same type, when multiples exist on the study. Forms that can be added multiple times include Sponsor/Funding, Drug/Biologics/Dietary Supplements, Medical Devices and Children.
The customized application is saved by clicking the ‘Done’ button at the bottom of the page. Clicking ‘Done’ saves the added forms and returns the user to the Forms page where the form names become hyperlinks, and the forms can be opened for editing.