Protocols - Templates

Overview

As a protocol administrator, system administrator, implementation project team member, or business analyst you can configure the protocol system so that it supports the business practices/policies, types of research, and organizational needs of your institution.  The Forms Designer functionality in Templates is available to users in the IRB System Configurer role and allows an Institution to customize how the Protocol module will work and what information is gathered for each type of Protocol.  Kuali provides basic templates that can be modified for your Institutional needs, below is an overview of how to create and maintain templates in Kuali Research Protocols.  The available templates types include the below:

• Protocol
• Amendment
• Renewal
• Renew/Amend
• Events
• Close Request
• Review Checklist
• Organizations
• Participating Site
• Checklists
• Admin Only

Accessing Protocol Templates

Users assigned to Administrator role(s) have access to Protocol Templates on the Administrator Dashboard.

In the Protocol Templates menu all Active, Pending, and Archived form templates for the associated Protocol Types are displayed.  This menu also displays the template Type, Version, Created, Created By, Status, and # IN USE columns.  All the displayed columns can be customized using the filters interface.  For more information on this interface see the Protocols - Filters article. 

There is only one Active template for each Template Type and you can edit these templates at any time.  Once a template is edited and saved a Pending version is created until it's published, at which point it becomes Active.  Prior version(s) go to Archived status and any protocols associated with that template will be maintained under that older version until the next edit when the current Active template is then applied. 

Editing a Template

When you want to edit any of the templates simply click on the current Active template which will show you the details of the template.  To proceed with a version edit click the New Version button in the top right-hand corner:

Be aware that certain elements in the Protocol template are required for functionality to work as expected.  Please be careful when modifying the below gadgets in the template:

• Person List - Do not remove Person, Researcher Role, Contact Roles, or Permissions fields.
• Attachments - Removing Attachment Type and Attachment Name fields will remove ability to list attachments on correspondences and eventual watermarking functionality.

Be aware that any edit to a template should be thoroughly tested in a test environment prior to applying to your live PRD environment since templates will affect functionality.

This will open a pending template in edit mode and give you the Form Designer options.  You can add different forms sections within the template, additional elements within the forms, edit existing sections/elements, reorder sections/elements, or remove elements entirely.  You can use the 'Add Item' to add an element, the trash icon to remove, or the gear icon to make edits to the field gadget.

On the righthand side you also have the option to toggle between Edit or View modes.  This allows you to have edit access to the template or preview how the template will look to an end user.

In the template you have the Save and Publish buttons in the righthand corner. Any edits/updates you make to the template will save upon the 'Save' action to the pending template.

Only when you click the 'Publish' button will the template become the Active current Template for disclosures and start being used by existing in progress protocols, withdrawn protocols, and new protocols going forward.  Make sure you have tested changes thoroughly before doing the publish action; especially in your live PRD environment.

Also available in the righthand corner are the Export Template and Import Template options.

These options allow you to export a file in json format so you can apply to other templates and environments with the import feature.  The exported json can also allow direct edits by those with enough functional knowledge to make those changes.  The export/import option is a good way to thoroughly test template changes in a lower test environment, export, and then import in your live PRD environment.  Be aware, the Export Template and Import Template is a powerful tool that should be used carefully since template changes affect how the system functions and always requires testing; especially after the import action please confirm all looks and behaves as expected. Also, be aware when importing/exporting templates that contain a Training Gadget with an external key you will need to update it to the new external key for the environment where you are importing for it to work as expected. The same is true for the Assign Ancillary Review gadget, you will need to confirm that the same Ancillary Reviewers are available between PRD and SBX, or update the Ancillary Reviewer selection manually after you import the SBX template to PRD. Please note, the import will only bring in the data for the Form and the information in Roles and Attachments will need to be manually updated. 

Using Form Designer

In the Protocol Type templates there is also the below banner across the top of the screen that gives you access to the different options of the protocol template (it defaults to the Form selection view):

• FORMS - allows you to use Form Designer to drag and drop elements in your template to gather information.  You can also change the order, edit field/section names, delete sections, and a number of other features.  
• ROLES - allows you to customize the Research and Contact roles you want to be made available in the protocol.  It also lets you default permissions for the given role when added to a protocol. More information on the functionality can be found in the announcement here.
• ATTACHMENTS - allows you to customize the general and personnel attachment types you want to be made available in the protocol and whether these attachments are required.

Once a new protocol template version is initiated the Form Designer become available and gives you the option to design the overall layout of your protocol form and what elements/fields are within the sections.  For example, within your protocols template you may want to have a Protocol section to gather general information, Persons list to get protocol personnel information, Species list, etc.

The +Add Item button within the forms will open a side window giving you options within Layout, Elements, and Integration that can be added to the given form.  More detail on each specific gadget can be found in the Form Gadgets article.

Layout - Allows you to configure major parts or sections of your protocol form.  This gives your protocol template it's general structure and design.  These added sections can then be further customized with specific attributes or options via the Elements options.  For example, adding a general Section with a field text entry or adding a Questionnaire Section to gather information via questionnaire functionality.

FYI, in Protocols the only place where permissions can be granted on a per protocol basis for protocol personnel (i.e. full access, view access) is within a People Section.

Elements - Customize specific parts of your protocol form with a variety of options like adding a text field, radial button, lookup, date selector, etc. to the specific section of the template. Certain elements may be pre-loaded with selections, such as the country drop down list, and others are configurable so you can customize the options available.

Integration - Gives options to select data from other sources.

Once you select the desired Layout, Element, or Integration option it will open another window where you can specify more detail and settings for the given selection.

Once you click Save it will be added to the protocol template where it can be moved to the desired order via the three hash mark icon on the lefthand side.  You can also delete it or edit it further via the trash and gear icons on the righthand side of the section/element.

Template Recommendations

When you start to create your templates the below are recommendations or tips to help make the experience and end result the most successful:

• The 'Attachments List' gadget in the main protocol template out of the box should not removed since this is what is used for watermark functionality (as explained in the configuration articles).  Also, 'Attachments List' gadget it the one that can be utilized to use in Correspondence letters if you want to list associated attachments.