Alyssa Childs ACRP-CP, Stiris Research
Most sites are truly in the middle of the COVID-19 situation – operating out of hospitals and clinics that have been turned upside down in an effort to stem the tide and protect employees. We are all eager to continue our studies, not only for hitting milestones and for data gathering, but for the sake of the patients who may be deriving some immediate benefit from an investigational drug or device. Now, more than ever, it is important to exercise patience with sites who have other priorities to attend to. As a CRA, I have been navigating this global health crisis with a variety of sites, and like many of you, learning as I go about what is helpful, what works for different sites, and how to best stay engaged with the team when a study’s immediate future is in question.
What does this mean?
- Avoid overburdening the sites; listen to what is being said and read between the lines to see if your study coordinators are feeling overwhelmed. Ask the study coordinator what they can complete from home – is there access to Electronic Medical Records? Scanning and redacting source documents is not feasible right now, given how time consuming and tedious it is, not to mention possibly running afoul of data protection laws in certain countries.
- Only do what is necessary for the study to safely continue (or safely stop); if they are not life-saving studies, stopping the spread of COVID-19 is most important.
- Determine the acceptable tolerated amount of risk for the subjects, depending on the nature of the study and not impacting their safety.
Aside from backing off the pressure, there are things you can actively do to assist sites:
- Help to proactively prepare for the protocol deviations that are likely to arise during this time with active subjects.
- Provide updates to the site on the status of a study whenever possible.
- Discuss the status of IP – is it expiring? Can it be shipped? Does it need to be shipped?
- Conduct remote reviews of the critical values that an FDA inspector would look at (e.g. eligibility criteria, concomitant medications, medical history, prior treatment, adverse event follow up, etc.).
- Discuss how to handle documenting COVID-19 should a subject exhibit symptoms or test positive.
- Keep track of how much data will need to be kept up on and use it to forecast what will need to be reviewed at the next visit – will you need more people, more time?
- Just ASK – how can we help you? This doesn’t necessarily mean something study related. Sometimes it’s nice to just connect with another person and share your experiences with this unprecedented situation.
Bear in mind that a lot of study coordinators are RNs – they may be literally on the front lines of this pandemic too. The best we can do is be as accommodating and supportive as we can – send check-in emails, resolve open action items, catch up on those small things that may have fallen to the wayside due to the initial chaos. We are all in this together, and now is a great opportunity to show your sites that you truly do care and will be ready to hit the ground running when we come out on the other side of this.
Want to know more about Stiris Research? Have a question? Just want to connect to another human being during a global crisis? Email us at firstname.lastname@example.org.