Mobile Technology
FDA responses to questions regarding the use of mobile technology in clinical investigations.
From Florence’s Complete Library of FDA eRegulatory and eSource Guidance
What access controls should sponsors implement for mobile technology accessed by study participants for use in clinical investigations?
Basic user access controls (ID code, username and password combination, electronic thumbprints, and other biometrics) should be implemented. If study participants use the mobile technology, there should be access controls to ensure that entries come form the study participant. If access controls are impractical, the sponsors can get a signed declaration from the study participant that they will be the only one using the device (from 2017). Documentation in the Florence Library of FDA eRegulatory and eSource Guidance
When using mobile technology to capture data directly from study participants in clinical investigations, how do sponsors identify the data originator?
When a mobile technology transmits data to the sponsor’s EDC system, the data element identifier should be created that automatically identifies the particular mobile technology (e.g., name and type) as the originator of the data element. Each electronic data element should be associated with an authorized data originator (from 2017). Documentation in the Florence Library of FDA eRegulatory and eSource Guidance
Does the FDA consider the mobile technology to contain the source data?
The FDA considers source data as the data that are first recorded in a permanent manner. For data collected directly from study participants through mobile technology, the first permanent record is located in the sponsor’s EDC system or the EHR, and not in the mobile technology, so that would be the source (from 2017). Documentation in the Florence Library of FDA eRegulatory and eSource Guidance
What should sponsors consider when implementing audit trails on data obtained directly from study participants using the mobile technology in the clinical investigation?
When data is copied or transmitted directly from the mobile technology to the sponsor’s EDC system, the audit trail beings when the data enters the EDC system. The EDC system should capture the date and time the data entered the system and the data originator. The mobile technology should be designed to prevent unauthorized modifications to the data. If data elements are modified, they should have data element identifiers that reflect the date, time, and data originator and the reason for the change (from 2017). Documentation in the Florence Library of FDA eRegulatory and eSource Guidance
What should sponsors consider when using a risk-based approach to validation of mobile technology used in clinical investigations?
Validation needs to ensure that the mobile technology is reliably capturing, transmitting, and recording data to produce accurate, reliable, and complete records (from 2017). Documentation in the Florence Library of FDA eRegulatory and eSource Guidance
What security safeguards should sponsors implement to ensure security and confidentiality of data when mobile technology is used to capture, record, and transmit data directly from study participants in clinical investigations?
The mobile technology must have encryption and basic user access controls in place. Other safeguards that they can consider implementing are remote wiping and remote disabling, disable function for installing and using file-sharing applications, firewalls, and procedures to delete stored health information before discarding/reusing the mobile device (from 2017). Documentation in the Florence Library of FDA eRegulatory and eSource Guidance
Does FDA expect sponsors, clinical investigators, study personnel, and study participants to be trained on the use of a specific mobile technology if the technology is used in a clinical investigation?
Yes (from 2017). Documentation in the Florence Library of FDA eRegulatory and eSource Guidance
From Florence’s Complete Library of FDA eRegulatory and eSource Guidance
The summaries presented in our library are for informational purposes only, they are not for implementation in operations. Please consult official FDA guidance documents for operational use.
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