System Rules in the Context of the MLM

• The point person has to enter Draft Mode to make changes to any MLM components, not only to edit the translations for any of the fields or add translations for new fields, but also to edit translations for Survey Settings or ASI messages, or to do things like exclude fields from being translated.
  
  
  
• If you edit a field or add a new field a form in the Online Designer, there is no prompt to update the corresponding translation, and only a vague notice that a translation is missing on the View detailed summary of all drafted changes page that via the message that no language translations have been modified.
  
  
  
• If you remove a Spanish translation in the MLM, REDCap does not flag this change as critical issue.
  
  
• If you relabel the Spanish translation of radio button, checkbox or drop-down option, REDCap does not flag this change as critical issue.
  
  
• When you make changes in the MLM, you have first have to Save Changes in the MLM, and then on View detailed summary of all drafted changes page, there will be vague note that some translations have been modified, but no details about the changes will not be captured.
  
  
  
  • This same behavior is true, even if you are only making changes in the MLM.
    
    
    
• If you Remove all drafted changes instead of submitting the changes, any changes you made in the MLM will also be removed.
  
  

Best Practices for Managing Change

Because a project using MLM has some inherent fragility in relation to production changes, the first and most important rule is to minimize change. We lead with this advice for all projects when it comes making production changes, and we are repeating it here for emphasis. Be cautious. Careful planning for change, careful execution in making changes, an careful and continuous monitoring of change can help mitigate the inherent risks of modifying a project using the MLM.

Create a Change Management Plan

A change management plan outlines the roles, requirements, and responsibilities involved in making changes. It should also address how change is being monitored and tracked both inside and outside of REDCap, and who the study team works with to get translations. It should outline how changes are tested and validated. Consider maintaining a change log, outside of REDCap, to record the details of the changes that were made to the project.

We also recommend including details about how to use the MLM tool to update translations, and include screen shots and step by step instructions. Considering maintaining a data dictionary of fields, survey settings and ASI messages that have translations.

Considering routinizing change activity by setting aside regular time on a monthly or quarterly basis to review with your team any issues with the project or changes to requirements that will necessitate making modifications to your project.

Keep the plan up-to-date and stick to it.

Limit Who Can Make Changes

Apply the principle of least privilege to who has permission to the Project Design & Setup user right. Only users with the Project Design & Set user right can make edits to the forms, fields, Survey Settings and ASI messages in both Online Designer and in the MLM tool. Limiting which users can make production changes is important for all projects and critical for projects using the MLM.

Test Changes before Implementing Them

The best practice for testing most production changes is for the point person to first test their changes in an up-to-date copy of their production project. When you make a copy of a project you can copy over all the MLM settings and translations from the production project to the test copy.

For a project using MLM, testing first allows the team to vet their changes and validate their translations. It also creates a road map for the team to implement their changes in their production project. For projects using the MLM with an e-consent, testing first is critical to reduce the potential of invalidating the consent form and creating a regulatory issue.