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Under new guidance issued Wednesday regarding ongoing clinical trials conducted during the COVID-19 pandemic, the FDA called for use of remote monitoring systems if on-site visits by study participants are no longer possible. Anand Shah, FDA deputy commissioner for medical and scientific affairs, remarked "we want to support the continuance of these clinical trials in compliance with good clinical practice and minimising risks to trial integrity, while also safeguarding the health and well-being of study participants."
Under the new guidance, the regulator noted that as trial participants may not be able to come to the study site for various reasons tied to the COVID-19 outbreak, sponsors should consider other options for safety assessments, such as phone contact, virtual visits or alternative locations. They should also "consider optimising use of central and remote monitoring programmes to maintain oversight of clinical sites," the FDA said.
However, the agency noted that "in making the decision to continue use or administration of the investigational product, the sponsor should consider whether the safety of trial participants can be assured with the implementation of the altered monitoring approach."
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