Decision to Review On-site Data that Was Remotely Monitored Up to Sponsors, FDA Says
Sponsors should look to their own risk assessment models to determine if trial data that was monitored remotely should be re-examined once the pandemic eases and on-site monitoring visits resume, the FDA says in the latest revision of its guidance on conducting clinical trials during the COVID-19 pandemic.
Sponsors may determine that on-site follow-up of remote monitoring activities is warranted, for example, if they see certain sites with data anomalies, higher frequencies of errors, significant protocol violations or dropouts compared to other sites, the agency said in the final guidance.
The agency does not offer further advice on the subject other than to emphasize that remote monitoring should be focused on the same critical data and processes as on-site monitoring.
The 36-page guidance includes 28 answers to questions received by the agency about conducting trials during the COVID crisis. First released in March 2020 at the start of the pandemic, it also provides general recommendations for trial sponsors that should be considered throughout the emergency (CenterWatch Weekly, March 22, 2020).
Read the full guidance here: https://bit.ly/3DLerjD.