1. What is the general goal of the feature?
As the designer of a study, I must be able to ensure that each change made to a form’s data can be traced to the person who made it. This must be the case even if the changes are made entirely offline before form submission.
This is a companion feature to Collect: keep history of changes to values in the form.
There is also a related requirement to track comments about the changes made. Ideally the specification for tracking username can be general enough to also meet that requirement but if not, that feature will be tracked separately.
2. What are some example use cases for this feature?
This kind of traceability is required by various study protocols. For example, @dr_michaelmarks pointed here to the ICH Good Clinical Practice which is an international standard followed by federal research agencies around the world (e.g. FDA in the US or NIH in the UK). It states (CRF means case report form in this context):
4.9.3 Any change or correction to a CRF should be dated, initialed, and explained (if necessary) and should not obscure the original entry (i.e., an audit trail should be maintained); this applies to both written and electronic changes or corrections (see 5.18.4 (n)). Sponsors should provide guidance to investigators and/or the investigators' designated representatives on making such corrections. Sponsors should have written procedures to assure that changes or corrections in CRFs made by sponsor's designated representatives are documented, are necessary, and are endorsed by the investigator. The investigator should retain records of the changes and corrections.
5.18.4 (n) gives the following responsibility to trial monitors:
Informing the investigator of any CRF entry error, omission, or illegibility. The monitor should ensure that appropriate corrections, additions, or deletions are made, dated, explained (if necessary), and initialled by the investigator or by a member of the investigator's trial staff who is authorized to initial CRF changes for the investigator. This authorization should be documented.
3. What can you contribute to making this feature a reality?
Spec work, project management, software development
I have talked to @dr_michaelmarks and @chrissyhroberts about their requirements (thank you). They need the username logged in the audit file along with the value change itself. A common workflow for them will be that a device gets handed to a supervisor or monitor who will request changes. They are flexible when it comes to the user interface. We discussed a couple of different ideas:
- a required user identifier field in the form that is always blank on form open and must be filled
- a dialog that confirms user identity on form open