COVID-19 and Virtual Trials for Clinical Research

How is COVID-19 impacting your research?

The FDA has issued a document outlining non-binding guidelines for running studies during the COVID-19 Pandemic.

Download a copy of the FDA recommendations.

In many situations, study protocols will need to be reviewed and adjusted to address how patients must be screened and managed during office visits.

Some of the modifications you might consider are:

• Adjusting the follow-up visits to see if patients may be able to come in during a later period.
• Replacing in-person visits with online assessments. While some testing and patient assessments may not be possible, a lot of the typical processes can be completed remotely.
• Consider using QuesGen’s ePRO (electronic Patient Reported Outcomes) process to collect data. Questionnaires can be sent to participants either through email or text and the data can be entered on a smartphone, tablet or home computer.

If you would like to review possible systems changes to continue running your study, please reach out and schedule a review with our systems engineering team.