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FDA/EU/MHRA/TGA Clin Monitoring Suggestions COVID

FDA/EU/MHRA/TGA Clin Monitoring Suggestions COVID

Submitted by • April 27, 2020 www.ddismart.com

There are several suggestions, recommendations from different health authorities for sponsors to handle clinical trial aspects during this very challenging time of COVID. Most of them recommended not starting any new studies for time being. For the ongoing studies, below is the compilation from their documents pertaining to Clinical monitoring of ongoing studies:

MHRA
Remote monitoring for trials

We support remote monitoring where appropriate but consider the following:

Direct access to patients EHR (Electronic Health Record) away from the site creates issues around confidentiality. Consider where this access takes place, for example will CRAs (Clinical Research Associates) be accessing records in an open plan office, public space or other location where others who are not authorised could view sensitive information
Trial participants will need to consent to any identifiers leaving the site and be assured that their confidentiality will be protected

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