The COVID-19 pandemic created numerous challenges for companies involved in clinical trials. At the same time, the pandemic has created an urgent need for remote monitoring by both companies wishing to keep their trials moving forward and for companies initiating new trials on schedule.
The traditional onsite monitoring visits, where monitors are required to check the data entered in the case report form (CRFs) against source, to ensure that the protocol is executed correctly, are obviously less practical during COVID-19 period.
Regulators (FDA, ICH and Iso) accept and encourage sponsors to explore more effective monitoring strategies. There is now an acceptance of moving away from the practice of 100% SDV of patient data. The regulatory bodies understand that sponsors need to look to improve the efficiency of cost and safety in conducting clinical trials, especially during COVID-19, when monitors cannot enter clinics and traveling is difficult and restricted.