Prelude EDC Feedback Tool Has Been Enhanced to Support Client Approval and Testing Documentation
By Tommy Jackson on March 10, 2016
Prelude announced today that its feedback tool has been enhanced. Clients use Prelude EDC’s feedback tool during the study build process to communicate changes and needs to their Prelude Project Manager. Feedback is integrated into the study and allows users to leave feedback directly on the pertinent field.
When feedback is left, as with all data entered into Prelude EDC, there is a full audit trail of who left the feedback and when. The feedback tool tracks the communication between the Sponsor and Prelude related to study design needs.
As expressed by one of our clients, “We appreciate the iterative development study process and relationship we have with Prelude. The feedback tool allows us to quickly note any changes. It keeps track of the changes we have requested, and allows us to have a team of people testing and interacting with the study during the development phase. As the PM in charge of this process, this enhancement allows me to approve the suggested changes before Prelude implements them. And the audit trail allows me to see which of our staff entered the change so I can follow up with them if I have questions prior to approving the change.”
The enhancements include addition of a change approval column and a reviewed column. The change approval column is intended to be used by the project lead to indicate whether the suggested change should or should not be made. This is important because many clients engage teams to collaborate in and test the study build. Each of these team members comes from a different perspective and might make different suggestions based on their experience. Some of the changes suggested might not be needed or might be in conflict with other changes, so this allows the project lead to review and designate each change as desire prior to Prelude’s implementation.
The reviewed column allows clients to better track and review the requested changes. Once the change is made, the client needs to ensure the change is made as desired. Many clients were tracking this offline on excel sheets because it was an important quality assurance process. Now, they can quickly indicate their review directly in Prelude EDC which gives them a full audit trail of their approval.
Additionally, the testing documentation provided to clients as a suggested starting point for testing their study has been enhanced. It is now available as a pop-up window rather than a download. This makes it easy to have the testing document beside the study to ensure thorough testing.
Prelude Dynamics is an industry leader at providing innovative software-as-a-service technology solutions for clinical trials across the globe. The company’s flagship product, Prelude EDC, offers secure and configurable data capture and information awareness tools for the advancement of human and animal health, compliant with FDA/CVM and EMEA regulations. Prelude EDC facilitates real-time data collection, querying, cleaning, reporting, and analysis all based on the needs of the researchers. The company was established in 2003 with a goal to speed the study process, improve data quality, and facilitate easy data entry through automation.