The study build is the most volatile and, therefore, the most important part of the study’s life cycle. Keeping a good record of the build gives the rest of the study a fighting chance at success. It’s a time for testing, training, re-testing, amending, testing and retesting again. Did we mention it’s a time for testing? Changes get added and reverted then added back in, the final protocol may not be ready, there are usually multiple people requesting updates to study forms, sometimes conflicting with each other. It is important to be able to see exactly when requests were made and by whom.
This “story” of the study build has a major impact on the study once it goes Live and after it has been completed. It even affects future studies. Being able to see all in one place where the build went right and where there is room for improvement makes site-training easier, it provides a starting point for future study builds, and it streamlines the development of future protocols.
The Prelude field spec and feedback features are the most powerful tools for telling this story. The field spec allows the team to see in a nutshell how every form and field is set up. If they are unsure the effects of a calculation or constraint on a specific field, they can go directly to the form in question and test it. Then they can add feedback directly into the system if they feel a change is needed. From there the request goes through the feedback cycle until it is resolved. Then it is tested again. Prelude provides more feedback categories than any other EDC provider for added clarity and efficiency.
Each team member can use these tools to see exactly what changes have been requested, which changes have been approved, and the completion status of the approved changes. They can view at a glance all roles, permissions, constraints, calculations, etc., to find everything they need to know about the progress of the build, and they can view a succinct record of the Prelude team’s responses to each feedback item. Furthermore, the audit trail provides information about who left what feedback or query and when. In this way, Prelude offers a full package of features to streamline the build process and keep a thorough record each study’s build.