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variables in the clinical trial datasets, whether an assessment was conducted inperson or remotely (including type of technology used), as well as the date of the assessment and the person who conducted the assessment. Sponsors also should ensure that remote data acquisition, transmission, and storage are secure, and that the privacy of trial participants is protected. When sponsors use electronic platforms to perform remote assessments that transmit data directly into trial records, these platforms should include automated audit trails. Technology and Technological Support: Sponsors planning to use remote electronic assessments as part of a clinical investigation should use appropriate technology and develop procedures for provision of technology and technical support to trial participants, investigators, and/or other trial personnel to facilitate those assessments. For example, sponsors could develop a plan to accommodate trial participants who are either already enrolled in a trial or may be enrolled in a trial in the future, but who do not have access to appropriate communication technology (e.g., cell phones or Internet), by providing trial participants with these services. Specific considerations for certain COA types are explained below. PerfO- and Interview-Based ClinRO-Specific Considerations: For these types of assessments, sponsors should consider: (1) appropriateness of remote assessment for the type of clinical data to be collected; (2) special investigator training to administer the PerfO or interview-based ClinRO assessments remotely; and (3) procedures for assessing and confirming the safety of trial participants, their privacy, and appropriate setting and resources to adequately complete the assessment. Recognizing that components of the PerfO and interview-based ClinRO assessment for some trials may specify visualization or in-person interactions with trial participants that may be difficult to replicate through remote interactions, sponsors should assess whether these components can be evaluated in an alternative way that still permits an accurate clinical assessment. 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. Sponsors should consider Contains Nonbinding Recommendations 22 whether the information that can be collected remotely will be sufficient to reliably assess the clinical outcome and support robust conclusions for the study. PRO- and ObsRO-Specific Considerations: For these types of assessments, sponsors should consider: (1) potential for missing data when switching from in-person assessment to remote assessment; (2) whether switching from use of paper- or electronic-based PRO and ObsRO assessments completed independently to assessments administered verbally by another person may lead to bias of scores (e.g., if trial participants try to please the site staff by offering ratings that might not truly reflect their experience); and (3) that data collected with PROs and ObsROs through verbal administration should not be considered a substitute for required safety monitoring throughout the trial. 38 To minimize potential bias resulting from verbal administration of PRO and ObsRO assessments, sponsors should ensure interviewer training and use of an interview script. Sponsors may also consider using automated virtual interviewers or a trained neutral third-party interviewer to administer the assessments remotely. The potential for missing data is also a limitation when switching from in-person to remote assessment using paper-based PRO or ObsRO assessments, if the trial participant or observer fails to complete all or part of the questionnaire within a given timeframe. To mitigate potential for missing data, sponsors should consider remote electronic capture of these assessments through technologies that can remind trial participants to complete the questionnaires and/or verbal administration at the time instructed (assuming appropriate steps are taken to minimize bias from verbal administration). Q15. I am a study monitor and am unable to conduct on-site monitoring visits due to the COVID-19 public health emergency. May I remotely perform the site monitoring visit? What recommendations does FDA have for how I can remotely perform source document review? FDA regulations require sponsors to monitor the conduct and progress of their clinical investigations.39 The regulations are not specific about how sponsors must conduct such monitoring and are therefore compatible with a range of approaches to monitoring that may vary depending on multiple factors. Therefore, certain aspects of site monitoring visits may be done remotely if technically feasible. FDA understands that there may be deviations from the timing of on-site monitoring visits set forth in the trial monitoring plan and procedures, and that sponsors may consider ways to replace on-site monitoring visits with remote monitoring visits during the COVID-19 public health emergency. Further, there may be components of an on-site monitoring visit, as outlined in the trial monitoring plan, that cannot be completed remotely. During the COVID-19 public health emergency, 

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