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A site user logs into the application and then hands the tablet to the subject, who then completes the ePRO. Is this process compliant to regulatory expectations?
Dr Medhavi Rane
Regulatory authorities such as FDA would not consider this site-administered ePRO system to be in line with the eSource principles outlined in FDA’s guidance, electronic source data in clinical investigations. For the purposes of record keeping, audit trail, and inspection, the study participant who participates in the outcome measure and enters information in the ePRO device should be identified as the data originator. In the case of the site-administered ePRO systems, the ePRO device should be programmed to accurately reflect that the study participant entered the information in the diary.
If the study participant is physically entering the information in the ePRO device, then the ePRO device should be programmed to accurately reflect the study participant as the data originator. A signature by the participant or a confirmation from the site would not meet the eSource principles outlined in the FDA guidance.
What is regulatory expectation on validation of ePRO questionnaire?
Dr Roshni Rana
Regulatory authorities e.g. FDA recommends that sponsors conduct usability testing in small numbers of patients to ensure patients can complete the questionnaire as intended and to ensure that the use of different technology systems does not change how patients would read, comprehend, and respond to a PRO questionnaire e.g., changes in screen size do not lead a patient to answer a question differently, or patients can complete the questionnaire seamlessly irrespective of which technology system used.
As per ICH E6(R2), certified copy of the original record is a copy that has been verified by a dated signature or by generation through a validated process. If a site is printing the record directly from the validated EMR system and that record has a date and time stamp on it, would that be considered a validated process?
Dr Sanat Dave
For regulatory inspection purposes, if screenshots or paper printouts of the EMR fail to capture important data e.g., the data originator and the audit trail of the data that are recorded in the electronic system, then such paper records would not be regarded as certified copies of the originals and would be considered incomplete unless the accompanying critical data are included.
If a site does not certify their printed EMR stating that it provides review by the monitor, auditor, inspector upon request. Does this policy meet the regulatory requirements for complete access to source (EMR)?
Anita D’souza
As per FDA, it is not necessary to make certified paper copies of original electronic records if the original electronic record is available and accessible for viewing by the monitor, auditor, or inspector upon request.
Dr. Arun Bhatt is a Consultant - Clinical Research & Development,
Mumbai. Readers can send their queries at:arun_dbhatt@hotmail.com
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