How to prepare your teams for reopening.

As we approach our fifth month of the COVID-19 global health crisis, we’re now faced with the task of starting to reopen. We don’t expect to resume what was typical daily life, and we must navigate this new normal of clinical research as best we can. As part of our efforts, we encourage you to start having conversations with your internal staff, and research sites, as the clinical research community prepares for what is anticipated to be a very busy and very important time. Praxis has developed the following two lists of items to start thinking about – and actions to consider – in advance of relaunching studies and reopening research sites.

Internal study teams.  

With so much emphasis on patients and site staff, it is important not to lose sight of your own internal study teams. Ito ensure a smooth return to study activity, involve team members in the relaunch planning to create alignment on tasks to complete and goals to achieve. This will also help improve morale, which will trickle down to vendors and research sites. You may want to consider:

  • Scheduling regular meetings or touchpoints with internal teams and vendors to provide updates on relaunch planning
  • Surveying internal teams to get a sense of comfort levels and readiness before reopening screening
  • Assigning tasks that need to be completed prior to relaunch – be clear about expectations
  • Creating an internal countdown clock or calendar with tasks leading up to relaunch
  • Reviewing the study protocol and discussing if amendments might be necessary to account for home health/telehealth options, or allowing for new or different rescreening options or procedures
    • Don’t forget to plan for IRB review of these materials
  • Reviewing all study materials (recruitment, retention, site support) and making any necessary updates to reflect amendments, new messaging for health and safety measures, and so on
    • Don’t forget to plan for time spent on revisions, IRB review, and production of pieces
  • Discussing study changes that might be necessary, such as opening new sites in more locations to limit patient travel, or partnering with transportation companies for delivery of investigational product or other materials
  • Sending communication from the study lead or medical director when the study does relaunch to thank everyone for all their hard work and to essentially “kick off” the study again

Research sites.

There’s no doubt that research site staff play a critical role in the successful relaunch of study activities. These people will be on the front lines welcoming patients back, answering questions, and sharing new information. Provide them with clear, accurate direction and take the guesswork out of study relaunch to ensure a smooth transition back to study activity. Keep in mind that your study is not the only thing on their minds right now. Kindness, empathy, and appreciation will go a long way! You can also consider:

  • Having regular touchpoints with sites to communicate study status
  • Surveying research sites to get a sense of comfort levels and readiness before opening back up
  • Clearly outlining expectations for sites upon relaunch
  • Being aware of and tracking any new procedures at research sites (e.g., limited hours, ability to receive shipments, etc.)
  • Providing clear direction on how to handle key study situations, including:
    • Prioritization of patients and study visits
    • Backlogged site visits
    • Investigational product kept at sites that has expired
    • Missed study visits that need to be rescheduled
  • Offering a refresher on the protocol requirements and reviewing any protocol amendments or new procedures
    • Be sure to provide guidance on any in-home or telehealth visits
  • Checking in with study support sites (radiology, third-party labs, etc.) to make sure they are opening at the same time as the research sites and are prepared for an influx of patients
  • Providing sites with visit calculators to help with rescheduling missed appointments
  • Encouraging research sites to revisit any shared areas and sanitize appropriately
  • Encouraging research sites to reach out to patients in advance of their first visit back and remind them of any post COVID-19 changes within the office
  • Welcoming back research sites with a webinar to kick off recruitment once again
  • Asking the site staff to confirm that their site is following the most up-to-date CDC and local guidelines that are in place
  • Designating a team member whom research sites can reach out to for any questions related to COVID-19

 

Praxis is here to support our clients as we navigate this transition back to study activity. Contact us to find out how we can help you.

Any questions? Want to know more?

Contact us today.