E-signatures clarified in FDA’s COVID-19 clinical trial guidance

Regulatory NewsRegulatory News | 04 June 2020 |  By 

The US Food and Drug Administration (FDA) updated its guidance regarding informed consent for clinical trials during the coronavirus public health emergency to add information about electronic signatures for informed consent, and to provide clarification about remote assessments during clinical trials.
In its announcement regarding the updates, FDA said that it issued the guidance “because we recognize that the COVID-19 public health emergency may impact the conduct of clinical trials of medical products.” Recognizing that protocol deviations may be unavoidable because of changes happening in the wake of the pandemic, FDA’s guidance now includes a new question-and-answer (Q&A) item addressing 21 CFR part 11 compliance for the electronic systems used to generate electronic signatures for records of clinical trials.
The new Q&A specifically references FDA’s COVID MyStudies App, now available on both Android and Apple platforms, as an example of an acceptable electronic method for obtaining informed consent.
(RELATED: FDA’s MyStudies app provides platform for informed consent, Regulatory Focus 01 June 2020)
Though FDA does not certify off-the-shelf software systems as being compliant with federal requirements for electronic signatures, vendors can supply information to sponsors that will allow them to evaluate compliance.
If a Part 11-compliant electronic signature system is not available, an alternate means to obtain required signatures must be used. This could be a wet-ink signature, or a stylus- or finger-drawn electronic signature on a document that is then printed and retained.
Updates to the guidance also added information to a Q&A about remote clinical outcomes assessments (COAs). In the update, FDA includes four separate types of COAs that can be conducted remotely in clinical trials during the COVID-19 emergency. These include performance outcomes, interview-based clinician-reported outcomes, patient-reported outcomes, and observer-reported outcomes. The guidance recognizes that some sponsors may be conducting some in-person assessments on trial participants, while other trials may be using remote assessments because of safety considerations or local government guidelines and restrictions.
“When deciding whether to change their clinical trial protocols to include remote COAs, sponsors should evaluate” a set of general and specific considerations, says the guidance. As before, general considerations include the potential for increased variability in data, having appropriate technology, ensuring appropriate documentation and audit trails and the overall feasibility of a given assessment method.
For performance- and interview-based clinical research outcomes, sponsors should consider whether a remote assessment method will be appropriate for the outcomes being assessed. Investigators should receive appropriate training for remote administration of assessments, and the setting of the participant should be assessed to ensure privacy, safety, and appropriateness.
“When components of the assessment cannot be accomplished in a remote encounter, investigators should document, and sponsors should report in the clinical trial datasets, any aspects of the assessment they are unable to accomplish remotely,” notes the guidance. “Sponsors should consider whether the information that can be collected remotely will be sufficient to reliably assess the clinical outcome and support robust conclusions for the study.”
For patient-reported and observer-reported outcomes, special considerations include the potential for data to be missed when the transition is made from in-person to remote assessment, as well as whether bias could be introduced when switching from paper- or electronic-based outcomes assessments to an assessment administered verbally. Finally, the guidance clarifies that data collected through verbal administration is not a substitute for required safety monitoring.
“To minimize potential bias resulting from verbal administration of… assessments, sponsors should ensure interviewer training and use of an interview script,” said the FDA. “Sponsors may also consider using automated virtual interviewers or a trained neutral third-party interviewer to administer the assessments remotely.”


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Tags: coronavirus, FDA, US

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