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Compliance In Focus
Posted by Anna Eggleston on Wed, Jul 1, 2020

FDA’s New COVID MyStudies App for eConsenting

Each day we hear more updates on COVID-19 clinical trial testing with the hopes of finding a vaccination or cure for this deadly disease.

e-consent

Most of these studies still face the challenge of how to safely obtain consent while patients are in isolation or cannot travel to the facilities.

The Food and Drug Administration (FDA) heard these concerns and recently released a mobile app to assist with the collection of electronic informed consents for COVID-19 drug trials when face-to-face contact is not possible due to the pandemic control measures. The COVID MyStudies app allows for secure data storage, is 21 CFR Part 11 compliant and is available in the Apple App and Google Play stores free of charge during this public health emergency.

Through this app, the investigator will be able to send the informed consent documentation electronically to the patient or their legally authorized representative (LAR) for review. Once the patient or LAR has agreed to participate in the study and signed the consent, an electronic copy of the signed consent is provided for their records. The investigator will then be able to print the signed consent form for filing or transfer the file electronically.

Before the COVID MyStudies app can be used, the investigator must contact the FDA at CDERMedicalPolicy-RealWorldEvidence@fda.hhs.gov and provide their pre-IND or IND numbers if applicable. Next the investigator will coordinate with the COVID MyStudies team and provide them with their IRB approved informed consent documents. The investigator will then have the opportunity to review all informed consent documents within the app before they are finalized and incorporated into their trial. Once approved, the app is ready for use.

This is just another tool to add to your toolbox that will allow COVID-19 studies to obtain informed consent remotely and ensure that the clinical trial does not experience any unnecessary delays during this public health emergency. Please reference How to Manage Informed Consent and Protocol in a Pandemic for additional tools to aid in obtaining informed consent safely.

Besides COVID-19 trials, would you consider using an app to obtain consent for your studies? Please share with us your thoughts and other tools that you have implemented for your studies to safely obtain consent.

How to Safely Reopen Your Clinical Research Sites

Topics: COVID-19

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