Today’s crisis climate is creating a dichotomy in clinical research. On the one hand, researchers are experiencing major clinical research disruptions across the globe due to direct proximity to patients, priorities of healthcare workers, and a fragile overall healthcare ecosystem.
As a result, sites are closing, medical facilities are enforcing access restrictions, and there are constant delays or stoppage of non-essential studies. On the other hand, this health crisis is highlighting the critical need for clinical research due to ongoing COVID-19 trials.
The unique environment has researchers racing to enable remote capabilities with eClinical technology to continue study progress and updating SOPs to remain compliant in the transition to remote work. At the center of this split is ensuring the safety of the study participant.
This prioritization of safety has caused regulatory bodies and study partners to release guidances specific to maintaining and managing clinical trials during the global pandemic.
As a result, clinical researchers are asking questions and seeking workarounds to continue operations in response to site-specific adjustments. One central issue has surfaced — how do we continue to maintain compliance when working from home?
A main component of this compliance standard is the concept of remote monitoring for study partners. How can sites enable and manage this crucial process for study partners?
Please note all information included in this article is for the purpose of examples and not intended for specific client use without further consultation.
To better understand how to enable remote monitoring compliantly, our team of former clinical researchers reviewed the recent “FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic.”