About The Study
A research sponsor came to the Baim Institute during an ongoing study. It was clear that the existing CEC adjudication process was not going to be able to process the number of endpoint events to meet their expected timelines.
We were asked to adjudicate over 4,000 events within a seven month window to complete all adjudications prior to database lock.
To meet these aggressive timelines, we modeled our workflow and scheduled two meetings per week throughout the duration of the study to ensure that the timeline would be met. By deploying a team of Clinical Specialist we were able to review and prepare clinical narratives that enabled between 100 and 300 events by our panel of board certified cardiologists at each meeting. Our team of Clinical Specialists was able to efficiently processing diverse source documents to compile and organize the complex CEC dossiers to enable fast and efficient processing of each case by board-certified practicing cardiologist.
With a rescue study such as this, there are many challenges that need to be considered. In this case, they included:
- Developing an efficient source document and CRF tracking process for a high volume of events
- Establishing a consistent naming convention, QC and reconciliation process for the uploaded data, including a query generation and integration process
- Implementing the query generation and integration process by the Clinical Specialist
- Selection and training of the CEC members
- Maintaining the overall consistency of the adjudication process
- Reporting and metrics, including query status report
To address the above challenges for this engagement, we implemented various processes and quality control mechanisms. First and foremost, in order to maintain the proficiency of all CEC meeting preparation tasks, we assigned a dedicated CEC Ops Data Coordinator to the study. We also kept the assigned Clinical Specialists as the facilitators and note-takers for all meetings. Four CEC teams, consisting of three physicians each, were trained on the study protocol and rotated to avoid having meetings cancelled, which could adversely affect the timeline. To ensure the consistency and quality of the CEC adjudication, a QC process of the event adjudication was put in place and implemented before the database lock.
To help with source document and CRF tracking, we established a secure FTP site for the Sponsor to upload complete event dossiers. Additionally, to help keep consistency and accuracy in the process,theSponsor was able to upload query responses with comments and related supplemental documentation to the secure FTP site.
The result of these process modifications and technology implementations was that our CEC was able to adjudicate the entire 4,000-event backlog within the seven-month timeframe that was allowed.