The GCU - IRB Modification Form should only be used for those who have approved applications. If your application is not approved and your reviewer has asked you for revisions, you will need to revise your application. If you have questions about editing the form, you can contact the IRB office at [email protected]
Once you have logged in, click on Study Assistant, then click on My Studies.
Locate your study and click the Pencil and Pad icon under Click to open.
Select the GCU - IRB Modification Form.
If this is the first time you are creating a form, click Add a New Form from the top of the page.
The modification form is divided into 13 sections, including optional changes. When you begin editing the form, continue to scroll down to view the next section.
The modification form starts with a section explaining the form. Please reach out to the IRB office at [email protected] if you are unsure if this is the appropriate form for you.
This section contains information on the principal investigator (you) populated from your IRB application.
In section 1.3, you will select the check-boxes for the type of modifications that you would like to make to your study. If you select an option from the list, you will be prompted to answer questions related to your modification in the sections below.
Sections 1.4 through 1.12 are conditional, you will only be able to edit a section if you have checked the box for that section in 1.3 Type of Modification.
1.4 New Data Collection Procedure(s)
In this section, you are able to add new research collection procedures. Please follow the format listed in the description. If revised recruitment scripts and revised consent forms are required, they must be uploaded in the Documents section of the form.
1.5 Study Title Change
If you need to update the title of your study, please do so in this section.
1.6 Change in Study Personnel
This section will allow you to add or remove key personnel from the study. If you are modifying the Supervisor (Chair) for your study, please add them in section B.
When adding a user, click the + Add option. On the next page, you will be able to search for a user by first and last name. Click Find to locate the user and click on the checkmark under Select User to add them.
1.7 Change of Site
If you need to make changes to your site, please do so here.
1.8 Change in Enrollment
Please make any necessary changes to enrollment here. If you need to upload additional material, please do so in the Documents section at the end of the form.
1.9 Consent Change
If you need to make changes to consent forms, you can do so by revising existing forms or adding new consent forms. Please explain the changes you have made in the text section.
To revise an existing consent form, click Select or Revise Existing.
Find the consent form that you would like to change and click the icon under Create Revision.
The version number for the document will be automatically updated. Make any necessary changes to the title, date, and language, then select Check-out Document.
You will receive some brief instructions about how to download and open the file. Follow the instructions and click Complete Checkout.
The revision window should now indicate that you have checked out the document. If you need to make changes and return to the modification form later, you can click Save Consent.
To return to the page and check the document back in, navigate back to section 1.9 and you will see the document you have checked out. Click Select or Revise Existing once again.
Select the pencil and pad icon for the document you have started revisions on.
This will return you to the Content Revision page where you can select Check-in Document.
Select Choose File and upload the file you edited. When you are finished, select Save selected file.
The document will be checked back into the system, and you can click Save Consent.
The revised document will now be visible in section 1.9.
1.10 Recruitment Materials
If you need to update your recruitment materials, please do so here. Please be sure to upload any additional revised materials in the Documents section at the end of the form.
1.11 Instruments (surveys, questionnaires, interviews, etc)
If you need to update any instruments used, please do so here. Please be sure to upload any additional revised materials in the Documents section at the end of the form.
1.12 Other Changes
Any other changes that need to be made can be detailed here. Please be sure to upload any additional revised materials in the Documents section at the end of the form.
If additional documents are required for your study, please be sure to add them here in the Documents section when you reach the end of the form. You may also revise existing forms here.