Susan Wiskow, Senior Clinical Project Manager
One of the first questions I am asked as a Clinical Project Manager is “how fast can you get a trial up and running and get the first subject enrolled?” The answer, of course, is “that depends.” It depends on trial complexity, if the protocol is final, the type and number of sites being targeted, availability of the subject population, and many other factors. However, here are five steps you can take to help reach this critical milestone faster without sacrificing quality.
- Fine-tune your site qualification process to proactively identify high-performing sites and apply risk management principles in identifying sites with potential barriers to enrollment. In other words, establish metrics to define high quality sites, such as evidence of high enrollment for similar studies and site responsiveness including contract and IRB turnaround times. Likewise, identify barriers to avoid such as sites with history of inspection findings and limited research staff. Ask for evidence to support claims made by sites.
- Establish contract and budget parameters for negotiations in advance and track negotiations using a means visible to key stakeholders, such as an electronic Trial Master File (eTMF). Using this approach saves time in negotiations and having to seek approvals at each stage. Also, making the progress visible keeps all parties accountable and can help to identify and resolve issues earlier on in the process. The metrics you track will also be helpful when deciding whether to use a site for future studies.
- Track and maintain site and sponsor essential documentation in eTMF. Documents are collected and uploaded in real time to an eTMF. Here the sponsor, CRO, and sites have visibility and access to what is on file, based on selected permissions, without having to provide copies separately to each involved party. Being able to see at a glance what documents are left to be collected prior to activation allows all parties to focus on critical tasks.
- Use reliable central IRBs where possible. Working with high-quality central IRBs can significantly speed the process of protocol and consent approval compared to institutional IRBs.
- Create tools tailored to your study, to easily measure progress and to ensure no critical steps are missed. Use tools such as a comprehensive checklist to ensure protocol requirements, such as study specific training and other regulatory requirements, are met. Even better, ready-made eTMF trackers or reports can be used to manage all documentation required prior to site activations and track completion progress. Use of such tools can also help avoid errors and reduce regulatory risk.
These five steps can reduce your study start-up timelines, which should in turn lead to quicker enrollment. To learn more about RCRI’s ready to use solution, please contact Samantha Thrun at email@example.com or 952-224-2260.