On an average day, if you asked a clinical research professional to describe their workload, they would probably tell you that their ‘to-do’ list is too long to count and that their schedule is booked through next month (and possibly the month after that).
In a matter of weeks, however, the normal day-to-day has all but disappeared as most non-essential employees adjust to working from home in response to COVID-19. And in an industry where professionals have learned to not only survive, but even thrive, in the chaos of clinical research, thousands are now faced with clinic visits that have been canceled, projects that have come to a stand-still, and schedules that are suddenly wide-open. Which begs the question – how can clinical researchers stay productive during a pandemic?
1. Training (and re-training!)
If your institution has recently added new staff, or if it’s been a while since you’ve reviewed the Code of Federal Regulations, now is the time to take advantage of an opportunity for some in-depth training. Host virtual training courses on the applicable FDA regulations and the fundamentals of Good Clinical Practice to ensure that your team is well-equipped with a solid understanding of basic clinical research practices. Once you’ve trained on the basics, brush up on your current protocols to make sure you have a good handle on the requirements for your ongoing projects. Begin documenting what protocol-requirements may be impacted during this time. And finally, if you have the time, consider reviewing study protocols for any of your upcoming projects so that your team can hit the ground running once business resumes as normal.
2. Data Entry and Remote Monitoring
Too often we hear on-site research staff express feelings of being overwhelmed or behind on their work. That said, as many projects begin to hit “pause” on upcoming research activities, take this time to catch-up on data entry and query resolution for any projects that may have been previously de-prioritized. Look into secure, encrypted file-sharing technology to facilitate remote monitoring visits or assist your research sites with data entry. And continue following your research subjects remotely. Utilize telehealth if your protocol allows for it, and periodically check on the status of your subjects in the electronic medical record (EMR) for any potentially unreported adverse events. Although your responsibilities may change and shift during this pandemic, patient safety will always remain top priority.
3. Trial Master File Audit
When it comes to keeping things organized, clinical researchers are often the best of the best. However, if you have a pile of documents waiting to be processed, or you know your electronic naming conventions have been less than consistent, take some time now to audit and update your Trial Master File (TMF). Confirming that all gaps in documentation have been filled and that your file is ordered appropriately will make preparation for any upcoming monitoring visits or potential regulatory inspections much easier. You might even consider requesting a vendor audit of your TMF to really ensure that you’re Bioresearch Monitoring (BIMO) inspection-ready. With the help of an independent review, you can feel confident that the documentation in your TMF tells an accurate story of your clinical research study. Because, as we always say, “if it’s not documented, it’s not done.”
4. SOP Review
Your institution’s standard operating procedures (SOPs) are meant to provide the framework for a highly functioning and efficient workplace. Furthermore, when well-written, these procedures will offer the guidance and support for putting into practice all that the regulations and GCP require for the proper execution of a clinical trial. And most importantly, a strong set of SOPs will aid your institution in prioritizing human subject protection. After you’ve refreshed your understanding of FDA requirements and GCP, take a look at your institution’s SOPs. Do they include the appropriate provisions to promote a well-executed clinical study? Are there requirements that may be too stringent, so much so that your fellow employees are unlikely to follow them? Or might there be language that requires some additional definition and refinement? If your SOPs include requirements that are vague, niche, or outdated, their ability to offer accountability to your workplace will be inhibited.
These are just a few of our tips for continued productivity as a remote clinical researcher. If you have additional suggestions for staying productive during this pandemic, please include your ideas in a comment below.