Protocols - Update Protocol Template on Amendment

Overview

During the lifecycle of an IRB, IACUC, or IBC protocol an institution's protocol form may change. While existing protocols will retain the form that was used at the time of their initial submission, institutions often need researchers to answer new or updated questions the next time the protocol is updated. To help facilitate this Kuali provides a feature to update a protocol document when a new Amendment, or Renew & Amend submission is created.

Configuring Template Update

To setup template open the configuration screen for your module and review the following configurations - see also the IRB Configuration, IACUC Configuration, and IBC Configuration articles.

• Allow duplication of protocols using a template with Active Status or configured to update.
  • If you allow users to duplicate their protocols with the duplicate protocol template function turned off they are only allowed to duplicate protocols using the most recent protocol template. If you turn on the template update functionality then you can duplicate any protocol using a template equal to or later than the Protocol template version configured here. When users duplicate their protocol the template update message will display before they begin editing their form.  More information on protocol duplication can be found here.
• Update the protocol template of protocols with a template version of _ or later.
  • When this is turned on whenever an In Progress document with a Submission Type of New, Amendment, or Renew/Amend is opened the system will check the Protocol template version the document is linked to and if it's equal to or later than the template version indicated the document will update to use the newest protocol template. The template will NOT update on a returned protocol since we do not want to unexpectedly change the context of ongoing reviews.

Note: If an institution makes a large change to their protocol template the fields may have changed so much that an automatic update would result in substantial lost data. A major change to the template may also require the institution to fully re-review any protocols submitted on the new template. Configuring which template versions will trigger an update on amendment allows institutions to avoid these situations while still applying smaller manageable updates.

• Update Admin Only template on protocols with no Admin Only template or a Template of version _ or later:
  • When this is turned on whenever a Submitted for Review or Resubmitted protocol version of any time is opened the system will check the Admin Only template version the document is linked to and if it's equal to or later than the template version indicated in this configuration the document will update to use the newest protocol template.  If this config option is not available in your instance the admin form hasn't been enabled yet in your environment - more information on this functionality and how to request this getting enabled can be found here.
• Display message to protocol editor when the protocol template is updated
  • This configuration allows each institution to write a message that will display to the researcher when the system updates their template. You can point the researcher to the portions of the form that have been updated most recently so they do not feel the need to review their entire protocol looking for new questions.

What Happens After You Make This Update?

After you set this configuration to apply the active template to older template versions the system will look for any protocol that was created under that template version or later and the next time the protocol has either an Amendment or Renew/Amend action it will apply the active template version.  The user will get the above prompt alerting them that the template has been updated and include the custom message (if configured).  The user will then need to fill out the new fields that may have been added due to updating to the new template.  

Also, be aware that fields that were removed in the most active version will be removed from the protocol when applied.  So this is something you will need to account for when thinking about what template version you want to configure to update prior protocols.

Lastly, if you update the template version again it will automatically apply to all these same protocols configured (and protocols created after) upon the next Amendment and Amend/Renew action going forward.

Template Editing Considerations

1. All values will copy if the Field Key is the same: When a protocol updates to a new template any values will copy to the new version if there is a gadget with the same Field Key. If you have deleted a gadget, and added a different gadget with the same field key the value might not be valid any longer though. So if you decided that a radio button gadget needs to be a checkbox gadget then the data will not populate forward because those two gadgets store their data in different ways. You can also use this behavior to intentionally prevent data from pulling forward.  If you change a question significantly enough that you want your researchers to re-answer the question after a template update you can delete the old question and add the new version with a different Field Key so the answer will be blank after the template updates.
2. Only gadgets on the newer template will appear when comparing versions: If you compare two versions of a protocol that have different templates then only the questions that are on the newer template will appear. Any questions that are no longer part of your protocol, but are answered on the older template can be reviewed by opening the older template, but they will not appear on compare versions.
3. You cannot delete and then re-add multi select options: Every time you add an option to a multi select gadget like Radios, or Checkboxes a unique ID is created on the backend.  That ID is what's stored in the database when that option is selected.  So if you accidentally delete an option, and then manually add it back in then the system will generate a new ID when you re-add the option.  This will prevent that question from properly copying from one template version to the next. In this situation if you have not saved the template since you deleted the option you can refresh your browser and the template will revert to the last saved version.  If you did save the template after deleting an option you need to restore you will need to export a version of the template that includes the option you want to preserve and re-import that version in the template editor.
4. If you enable and then disable this functionality:  If you enable this configuration but subsequently decide to disable it will revert to the prior functionality and not update to the new template on an Amendment or Amend/Renew action.  Only those protocols that had an Amendment or Amend/Renew action before this configuration was disabled would be updated to the new template version configured.  If you then decide to enable again later with the same version or a different version to update it will update protocols on the next Amendment or Amend/Renew action on a protocol.