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 Tissue Only Protocols. The ‘Create New Protocol’ button will launch a new protocol initial questionnaire. Depending upon how the questions to the initial questionnaire are answered, the user will automatically be presented with either a Standard Application or a Tissue Application. Any user with access to the Animals module in Insight will have the ability to start a new protocol application.
The new protocol initial questionnaire 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. 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
Depending upon the answers in the initial questionnaire, the user is presented with either the Standard Application or the Tissue application. The Sponsor / Funding form is always required, regardless of whether the Standard Application or the Tissue Application is presented.
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. Any Staff Certification forms that were uploaded to the Attachments page will not be included in the PDF document.
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. Applications can only be deleted when the process in a status of “In Progress” or “Submitted”. Once it is sent to SRAC and is pending review it can no longer be deleted.
Clone Protocol – This button allows the user to clone any protocols that were electronically created through eIACUC. To clone a protocol, the user can optionally check the Include Staff and/or the Include Attachments box, then click ‘clone protocol’. A title for the cloned protocol must be entered and upon saving that title, the cloned protocol will be placed within the user’s Work in Progress tab.
Screenshot: Editing Full Title
The protocol Full Title 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.
For a Standard Application, the Detail Research Plan and the Abstract forms are always required. Other forms that are presented to the user are dependent on how the questions in the Standard Application are answered.
The ‘Hazardous Agent’ header will appear if the user answered ‘Yes’ to the following question on the Standard Application:
Other forms will be presented based on what is checked in the Special Considerations section of the Standard Application. Some of the forms can be answered multiple times. For example, for every Procedure that is part of the study, there will be a form to complete for each Procedure. Forms that are considered multiples include: Hazardous Materials, Tumor Production, and Procedures.
Ascites or Antibody Production: checking this will trigger the Antibody & Ascites Production form
Tumor implants or growth: checking this will trigger the Add Tumor Production form
Survival Surgical Procedure, Multiple Survival Operative Procedures, or Other procedures including minor manipulations, injections, non-survival surgery, behavior observations, etc.: checking this will trigger the Add Procedure form
Screenshot: Standard Application – 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.
For a Tissue Application, the required forms to complete are Sponsor/Funding and Tissue Application.
The ‘Hazardous Agent’ header will appear if the user selected a species of ‘NHP- Baboons, NHP- Macaque, Cyno, NHP- Macaque, Rhesus, or NHP- Squirrel Monkeys.
Screenshot: Tissue Application – 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.
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. Abstract) 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 Hazardous Agents and Procedures.
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.