European Medicines Agency Offers Revised Remote Source Data Verification Guidance

Guidance Expands Use, Scope of rSDV

The European Medicines Agency (EMA) has expanded the use and scope of remote source data verification (rSDV) for clinical trials in which patients’ private data are adequately protected, according to a guidance update released earlier this month.

In the fourth and most recent version of its guidance on conducting clinical trials during the pandemic, the EMA said it would allow expanded use of rSDV, but also noted the relatively relaxed approach might not be permanent.

“It should be noted that the simplification measures proposed in this document will only last during the current public health crisis until the revocation of this guidance, when there is a consensus that the period of the COVID-19 outbreak in the” European Union/European Economic Area, has passed, EMA said in the guidance.

Actions related to the use of rSDV should be proportionate and based on benefit-risk considerations and on contingency provisions taken nationally and locally by the authorities, with priority given to the impact on the health and safety of the trial participant, EMA said.

“Where a trial participant is unable to attend the site, other measures, such as home nursing—if possible given social distancing needs—or contact via phone or telemedicine, may be required to identify adverse events and ensure continuous medical care and oversight…however, the limitations and risks of such methods and the requirements for data protection should be taken into account and such alternative arrangements need to be adequately documented,” the agency added.

The guidance also covers new ways to look at initiating and altering trials. In addition, it offers new agency insights on safety reporting and risk assessment during the COVID-19 pandemic.

Edited by Michael Causey