An Amendment application is started from the Protocol Details page. To start an Amendment, select process type ‘Amendment’ from the dropdown box located to the left of the ‘Create New Process’ button, the ‘Create New Process’ button will launch the Amendment questionnaire. The Amendment questionnaire is a series of questions that will be used to determine what protocol data is changing and what forms or pages should be presented to the user for completion or modification.
Any user with direct edit or manage access to the protocol in Insight will have the ability to start a new Amendment process on a protocol. If a user only has View access, the user will not see the ‘Create New Process button’ on the Protocol Details page.
A single amendment application may include several changes. However, there are some restrictions on the types of changes that can be bundled in one application.
Note: Amendments to add or remove study staff cannot include other protocol data changes. The business reason for this is that the approval time for staffing amendments is usually much faster than other protocol data amendments. The screen shots below will show the nature of the amendment form and how answering certain questions will hide or reveals subsequent questions.
Screenshot: Starting an Amendment from the Protocol Details page
An Amendment can be submitted to either add or remove study staff from the study, which may or may not involve changes to the performance site (organization), or individual’s role by which they are performing.
For example: If the answer is ‘Yes’ to ‘Are you adding or removing a performance site?’, then the Performance Sites / Facilities form will be presented on the Forms page for modification.
If the answer is ‘Yes’ to ‘Are you adding or removing study staff?’, then the Staff & Access page will be visible for the user.
The next step is to check the appropriate boxes to indicate if study staff is being added and/or removed from the study. The names of the study staff are not entered into the input text box at this time. The names will be populated on the form, only after the study staff updates have been made on the Staff & Access page
To make the study staff changes, navigate to the Staff & Access page. Staff can be removed or added to the study directly from this page. For step by step instructions on how to add or remove staff, please refer to the Staffing section in the manual. A study staff’s assigned role cannot be changed during an amendment. If a role needs to be changed, this should be done by adding the staff with the correct role and removing the record with the incorrect role.
If a study staff member is already in the process of being added by a Work in Progress or Pending Amendment, a warning will be displayed (see below). Click “OK” to continue adding this person, or “Cancel” to discontinue adding this person.
When all changes have been made, move to the Submission page to complete the validation and submission process. Changes to the staff will only be displayed on the current view of the active protocol when the amendment is approved.
Screenshot: Amendment form
Amendment form, starting an Amendment in which study staff is changing.
Screenshot: Amendment
Amendment form, after a study staff member has been added (McNeal) and removed (Fallon) on the Staff & Access page.
Screenshot: Forms page
Forms page which is displayed after clicking the ‘Save’ button on the Amendment form, where study staff and the performance site required updates.
Steps to Submit a Study Staff Amendment
Click on the “Go to Humans” button or Humans tab.
Click on the appropriate protocol title.
Click the “Amendment” type of process and then click the “Create New Process” button.
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Complete the Amendment form
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Click the “Save” button to be brought back to the Forms page.
Click the Staff & Access tab.
Add or Remove the staff from the Staff & Access page.
Click the ‘Submission’ tab
Run the Application Review and fix any errors with the validation process. When complete click the “Submit” button.
Once you click the “Submit” button, the Amendment is automatically routed for electronic sign off to the Principal Investigator. You can track the progress of the sign off process by going to the Pending Applications page and clicking on the Workflow History icon in the row where the transaction appears.
An Amendment can be submitted to change data related to the protocol. If protocol information needs to be amended, user must answer ‘No’ to the question ‘Are you adding or removing study staff?’ in order to get the appropriate boxes to indicate which aspects of the protocol data will be modified.
Once the initial questions have been answered and the form is saved, the user will be returned to the Forms page where the Amendment form and other relevant protocol forms can be completed and then submitted. If attachment changes are required, move to the Attachments page to make changes. When all changes have been completed the process moves to the Submission page to complete the validation and submission process.
The Forms page consists of a grid with 3 columns:
Forms: Includes the Amendment form and other forms which can be updated by clicking on the form name hyperlink. The actual changes to forms are done by clicking on the hyperlink.
Form Action: Where the user indicates the type of action being performed for a specific form. Possible actions are Edit, Remove, or No Change. The forms displayed will be specific to what the user indicated will be amended. The rules for the radio button options are as follows:
If the form is optional and can only be completed once, ‘Edit’ and ‘Remove’ radio buttons display.
If the form is optional, existed as part of the initial application and allows multiples (i.e. drugs, devices, children or sponsor), the ‘Edit’, ‘Remove’ and ‘No Change’ radio buttons display.
If the form is optional, did not exist as part of the initial application and allows multiples (i.e. drugs, devices, children or sponsor), the ‘Edit’ and ‘Remove’ radio buttons display when clicking on the hyperlink (i.e. Add Agent)
If the form is optional, the form hyperlink is only linkable if the ‘Edit’ radio button is selected.
If the form is required, the Form Action column is blank because it is assumed that the only action that can be taken is Edit.
Last Modified: displays the date and time that the answers on a specific form were last updated.
Modified By: displays the person that last updated the form.
Screenshot: Forms page
Forms page which is displayed after clicking the ‘Save’ button on the Amendment form.
Screenshots: Completing the Amendment form:
Answer No to the Study Staff questions:
Select if the study involves intervention / interaction; if ‘No’ select the type of study:
Select if the study involves intervention / interaction; if ‘Yes’ the list of forms is presented, select all that apply:
The final section asks if attachments will be included or removed as part of the Amendment. In this case it is indicated that new or revised study-related documents (Diaries) will be submitted:
Screenshot: Forms page for an Amendment in which protocol data is changing on an eIRB created protocol.
In this case, the submitter has selected to update the Drugs / Biologics / Dietary Supplements data, which existed on the initial application - J 867)
Screenshot: Forms page for Amendment in which protocol data is changing on a legacy protocol.
For ‘Legacy’ protocols, which had been started and approved prior to the eIRB system, the Amendment form itself will be the only on-line form available for submission to the IRB for review, as no electronic forms are available for completion as the data was initially captured on paper application forms.
Note: Please see the sections in the User Guide for information on Staff & Access, Attachments and Validation & Submission.
The following buttons are available on this 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 Amendment forms and the list of any attachments that were uploaded as part of the Amendment process.
Note: Only those forms that actually changed will be displayed. For example, if there were multiple drugs on the study, and only one drug was amended, the drugs that remained status quo will not be included in the PDF.
View Full Application – Presents the user with a PDF version of the application, which includes all questions and answers from the Amendment form and the list of any attachments that were uploaded as part of the Amendment process. Also included are any electronic attachments uploaded for the Amendment process, with the exception of attachment types ‘Response to Review’ and ‘Staff Certification Form’.
Add / Delete Forms – This is disabled as it is not used for Amendments. Forms are added and deleted based on how the Amendment form itself it completed.
Delete Application – this allows the submitter or anyone with ‘Manage’ access to the protocol to delete the Amendment application. There will be a warning message when this button is selected. Once the application is deleted, it is no longer accessible through Insight.