Consent Management

Complex clinical studies can include different consent statuses at different stages of a study as well as for different participants that clinical research coordinators need to manage. The existing legacy application needed features to make managing these complex trials easier.


Role

User flows, user research, information architecture, user interface

Team

Product manager, business analyst, product owner, operations managers, multiple development teams

Audience

Clinical trials coordinators need to keep track of participant consent in multiple studies. Coordinators are very busy and using many different applications to run a clinical trial. The consent part of a trial is only one part rather than a frequent task so coordinators do not use a consent application often enough to become very familiar with it.

Diagram showing how document collections affect participant status

Adding vital features to a legacy application

IQVIA had an existing legacy application that sponsors could use to keep track of participant consent in simple studies. However, the process was difficult to manage for more complex trials. Studies can include different documents for different participants as well as different stages of the trial. Trials can be on-site, remote or hybrid. Participants need to read and truly understand what is expected of them before they agree to participate in a trial since some of the trial requirements can be invasive. Coordinators will want to quickly answer questions that a participant has about the trial while not standing over the participant’s shoulder as they read. The Readalong solution helps save the coordinator time since they can let multiple participants sign at the same time.

Results

Initiated a customer advisory board with support from division director