September 22, 2020
Previously released as FDA MyStudies, COVID MyStudies is now available as a free platform to assist investigators in remotely and securely obtaining informed consent from patients for eligible clinical trials when face-to-face contact is not possible due to COVID-19 control measures.
“The agency is providing this resource after hearing that investigators were having difficulties obtaining informed consent for clinical trials when patients were in isolation rooms in health care facilities or could not travel to outpatient clinics,” noted the FDA. By obtaining consent from patients remotely, COVID MyStudies can help ensure that clinical trials related to COVID-19 are not unnecessarily delayed.
COVID MyStudies is available on the Apple App and Google Play stores.
Before using the app, investigators must contact the FDA. If a pre-IND or IND number is available, it should be included in the preliminary contact email. Investigators will provide their informed consent documents to the COVID MyStudies team to be added to the app. They will then have a chance to review all informed consent documentation within the app before incorporating it into their trials.
Harvard Pilgrim Health Care Institute (HPHCI) was selected by the FDA to lead the development of the FDA MyStudies mobile app. HPHCI in turn selected LabKey Server as the supporting data management solution and Boston Technology Corporation (BTC) as the developer of the mobile interface.
The flexible architecture of LabKey Server and its ability to handle PHI/PII data in a manner compliant with HIPAA and FISMA regulations leant itself well to the COVID MyStudies project. The Registration Server utilized to manage electronic consent, authentication, preferences, and notifications, is built upon the LabKey Server platform. LabKey also provided the HIPAA/FISMA hosting environment for the application. You can learn more about how LabKey supported the FDA MyStudies app by reading our case study.
Contact the support team at FDAMyStudiesContact@harvardpilgrim.org
Contact FDA at CDERMedicalPolicy-RealWorldEvidence@fda.gov