FDA: MyStudies app offers platform for electronic informed consent
The U.S. Food and Drug Administration is making its previously developed FDA MyStudies app available to investigators as a free platform to obtain informed consent securely from patients for eligible clinical trials when face-to-face contact is not possible or practical due to COVID-19 control measures.
The app, FDA MyStudies, can now be found as COVID MyStudies in both the Google Play and Apple App stores. In addition to providing a mechanism for securing informed consent from prospective clinical trial participants, the app also gives investigators the option to incorporate branding specific to a clinical trial.
Informed consent can be sent to the patient or an authorized representative, who receives an electronic copy after signing. The investigator can securely access the consent electronically and can also generate a printed copy. All informed consent documents and the process for obtaining consent must still go through institutional review board review and approval.
For more details, please see the press release from the FDA.
Meditrial has developed rapid workflows to conduct risk assessment, implement rescue plans and execute solutions for ongoing clinical trials:
- Identify patients requiring follow-up
- Conduct investigator and study nurse calls for training to address the situation
- Obtain authorizations for decentralized data collection
- Support to patients for alternative access to needed care
- Prepare procedures and worksheets for remote collection of patient clinical data
- Monitor work instructions and trainings for site support and remote monitoring
- EDC and ePRO solutions to enable study continuity
- Privacy protection measures
Contact Meditrial for immediate assistance in Europe or the US.
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This article provides general information and does not constitute regulatory or legal advice. Requirements should be confirmed for the specific study, applicable regulatory framework, and markets concerned.
