What's involved in the Study Startup stage of a clinical trial?
A clinical trial occurs in three parts: startup, maintenance, and closeout. The startup stage of the clinical trial includes the initial steps to getting the study up and running. This is an important phase of the process since clinical trials that get off to a good start are more likely to succeed.
Key Steps to the Study Startup Stage
The study startup stage typically involves the first three months of the clinical trial. During this time, there are some critical steps to getting the study started effectively:
· Building a Budget
· Designing a Protocol
· Signing a Startup Agreement
· Initiating Documentation
· Customizing Kits for Sites
How to Mitigate Common Risks to the Clinical Trial Startup Stage
The study startup stage sets the tone for the rest of the clinical trial. Any resets to the timeline during this stage can negatively impact the client’s ability to meet their first patient visit if sites do not have the materials they need to obtain samples.
Here are some ways you can help mitigate this common risk:
· Be Responsive and Timely about Getting Documents Finalized
· Be Open to Collaboration
· Have Important Site Information Ready
The Project Manager’s Role During Startup
The project manager plays a vital role in every phase of the clinical trial process. During the startup stage, the project manager’s main goals are to establish regular communication, identify potential risks, finalize all necessary documentation, and get customized kits shipped on time.