by Susan Wiskow, Senior Clinical Project Manager
Excellence in clinical project management requires vision, understanding, adaptability, disciplined effort, and unrelenting focus on achieving your goals. Consistent implementation of best practices throughout the lifecycle of the project, as suggested below, is a key component to the success of your clinical project.
1. Understand the goal of the project and how it fits in to goals of company. Who will pay for the device? What data are you seeking?
2. Conduct a risk analysis to assess risk and plan mitigation strategies.
3. Who are your stakeholders? Address how to meet their needs in the Project/Communication Plan.
4. Recruitment planning starts with the first conversation you have with potential sites. If you wait until you notice trends in slow enrollment, you have wasted too much time. Build time into your site qualification process to discuss and document plans for subject recruitment.
5. Develop a process to move several activities forward concurrently during the start-up phase.
6. Partnering a Risk Based Monitoring approach with a strong Data Management Plan is a proven strategy to improve the quality of the data. It also reduces costs and hastens timelines to study completion.
7. Use available tools such as 21CFR11 compliant electronic trial master file (eTMF) and electronic Case Report Form (eCRF) database to manage essential documents and reporting trial data. This allows you to see the progress of document collection at any time, sites can upload documents, monitoring activities can be conducted remotely, and it helps ensure your trial is always inspection-ready.
8. Discern what metrics you will need to track from the beginning of the study and design reports accordingly. For example, create reports on: Enrollment, CRF completion, Monitoring SDV status, Adverse Events, and/or Deviations by Sites.
Execute to Achieve Goals
9. Execute, measure, and adjust throughout the entire study.
10. Learn to prioritize. Ask: does this potentially jeopardize subject safety? Is integrity of the endpoint data intact?
At the end of the trial, assess and communicate with your team on how can you do it better, smarter, and faster the next time.
RCRI experts can help you at any point during your clinical trial, contact please contact Samantha Thrun at email@example.com or 952-224-2260 for more information.