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investigational product accountability remain and must be addressed and documented. Storage conditions and investigational product accountability should be considered if the protocol is amended to permit alternative site infusions. Defining circumstances when discontinuing investigational product administration, while continuing study participation, albeit with potentially delayed assessments, may be an appropriate option when suitable alternative arrangements cannot be made. Q10. Considering that there likely will be delays to on-site monitoring of clinical trials during the COVID-19 public health emergency, what are FDA’s expectations in such circumstances? FDA recognizes that monitors may not be able to access the trial sites for on-site visits in a timely manner during the COVID-19 public health emergency. Sponsors should work to find alternative approaches to maintain trial participant safety and trial data quality and integrity, such as enhanced central monitoring, telephone contact with the sites to review study procedures, trial participant status and study progress, or remote monitoring of individual enrolled trial participants, where appropriate and feasible. FDA recognizes that delays in on-site monitoring may result in delayed identification of GCP non-compliance (including major protocol 19 See 21 CFR 312.59 and 21 CFR 312.62. 20 See 21 CFR 312.58(b) and 312.69 Contains Nonbinding Recommendations 15 deviations) at the clinical trial site(s) (including protocol deviations not due to the impact of COVID-19). Sponsors should carefully document situations where monitors were unable to access, or had to delay monitoring of, a clinical site. Sponsors/monitors should also include in their documentation of protocol deviations or other GCP non-compliance issues identified at clinical sites whether delayed identification was due to postponed monitoring. FDA recognizes that unique situations at clinical sites will occur due to COVID-19 control measures and will consider these circumstances when evaluating inspectional observations. Q11. How do I obtain signed informed consent from a hospitalized patient who is in isolation when a COVID-19 infection control policy prevents us from entering the patient’s room to collect a signed informed consent form? FDA regulations generally require that the informed consent of a trial participant (in this case, a hospitalized patient) be documented by the use of a written consent document that typically includes the elements of informed consent, as described in 21 CFR 50.25, and that has been approved by the IRB and signed and dated by the trial participant or their legally authorized representative at the time of consent (21 CFR 50.27(a)). When feasible, we recommend a traditional method of obtaining and documenting informed consent using a signed paper copy of the consent form, or use of electronic informed consent.21, 22, 23 If neither of these approaches are possible, the following procedures would be considered to satisfy FDA’s informed consent documentation requirement.24 Method 1: A photograph of the signed informed consent document can be transmitted to the trial staff 1. An unsigned consent form is provided to the patient by a person who has entered the room. 2. The investigator/designee arranges a telephone call or video conference call with the patient (and, if desired and feasible, additional individuals requested by the patient (e.g., next of kin)). 21 See the guidance for institutional review boards, investigators, and sponsors Use of Electronic Informed Consent in Clinical Investigations (December 2016). We update guidances periodically. For the most recent version of a guidance, check the FDA guidance web page at https://www.fda.gov/regulatory-information/search-fdaguidancedocuments. 22 For example, for FDA-regulated trials conducted during the COVID-19 public health emergency, FDA has made the COVID MyStudies app available in the Apple App and Google Play stores as a platform enabling investigators to obtain informed consent securely from patients when face-to-face contact is not possible or practical due to COVID-19 public health measures to control the virus. To facilitate free use of the app during the public health emergency, FDA intends to fund the technical assistance required to operate the COVID MyStudies app, which will be provided by the Harvard Pilgrim Healthcare Institute, as resources permit. For more information, investigators interested in using the app should see https://www.fda.gov/drugs/science-and-research-drugs/covid-mystudiesapplication-app. 23 See Q25. 24 The procedures suggested do not apply to the exception from general informed consent requirements under 21 CFR 50.23 or the exception from informed consent requirements for emergency research under 21 CFR 50.24. Contains Nonbinding Recommendations 16 3. To ensure that patients are approached in a consistent fashion, a standard process should be used that will accomplish the following: • Identification of who is on the call. • Review of the informed consent document with the patient by the investigator/designee and response to any questions the patient may have. • Verbal confirmation by the patient that their questions have been answered, that they would like to participate in the trial, and 

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