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Contains Nonbinding Recommendations 28 Q20. I am a sponsor and would like to use an alternate laboratory or imaging center48 for protocol assessments. What should I consider regarding when this approach would be appropriate and the selection of alternate laboratories or imaging facilities? Given that trial participants may not be able to come to the investigational site for protocolspecified visits at which laboratory tests or imaging would be conducted, sponsors should evaluate whether it is feasible to use alternative laboratories or imaging centers. The suitability of such alternative arrangements may vary depending on whether the protocol-specified procedures are related to eligibility criteria, safety evaluations, or endpoint assessments. In general, if trial participants cannot access a clinical trial site, alternative sites may be used for laboratory tests or imaging assessments that focus on the safety of trial participants when such tests and assessments are routinely performed in those settings (e.g., routine chemistries, blood counts, chest radiographs). 49 However, if the results of laboratory tests or imaging assessments are the basis for formal hypothesis testing, including primary or secondary efficacy endpoints and some safety endpoints, sponsors should consult with the relevant FDA review division. For example, disparities in laboratory measurements or imaging protocols will introduce increased variability and thus can affect type I and type II error rates. When baseline tests are necessary to characterize the eligible study population, potential variation in test performance or precision related to use of an alternative laboratory or imaging center may also warrant discussion with the FDA review division. For example, an inclusion criterion based on a commonly available, routine test performed as a safety screen (e.g., renal function on a metabolic panel) might be amenable to alternative laboratory collection with minimal impact on study results. Using an alternative laboratory for tests related to other eligibility factors could be more likely to affect study integrity (e.g., laboratory tests to identify a tumor biomarker required for inclusion, genetic test to identify a marker that is a critical inclusion criterion). It may be important for such assessments to be standardized at a single site or at most a few sites. Based on the nature of laboratory tests conducted for the purpose of protocol assessments, the alternative laboratory conducting such tests for investigational purposes will likely be subject to certification and other requirements under the Clinical Laboratory Improvement Amendments (CLIA).50 Alternative laboratory and imaging centers may also be subject to additional laws governing their operations. Q21. We are instituting trial participant visits remotely through video conferencing. Are there recommendations regarding best practices? 48 For IND studies, this would be laboratories and imaging centers not listed on the Form FDA 1572. 49 If a local laboratory or imaging center will be used for certain patients and will not replace the laboratory and imaging center specified in the Form FDA 1572 for all patients, these alternative facilities do not need to be listed on the Form FDA 1572; it is sufficient to retain documentation of when such facilities were used for protocol specified tests. The sponsor can accumulate these changes and submit this information to the IND, in for example, an information amendment or a protocol amendment. 50 For more information on CLIA, see https://www.cms.gov/Regulations-andGuidance/Legislation/CLIA/Downloads/Research-Testing-and-CLIA.pdf. Contains Nonbinding Recommendations 29 With the increasing use of telemedicine in clinical practice, a number of resources may be available to provide recommendations on best practices. FDA does not endorse any particular telemedicine best practices. However, from an FDA regulatory perspective, important considerations for trial visits through video conferencing include: • The investigator or study personnel who will conduct remote visits should be trained on how to conduct real-time video conferencing visits (e.g., training on the use of telemedicine for remote clinical trial visits). • Procedures should be put in place to maintain a trial participant’s privacy, as would be done for a clinical visit. • Both the investigator and the trial participant should confirm their respective identities with one another before engaging in a real-time video conference visit according to an identity verification plan developed by the sponsor.51 To provide the same information that would be documented during a face-to-face visit, the date of a real-time video conference visit should be documented in the trial records and, if specified in the protocol, the time of the visit. Investigators should consider asking for the trial participant’s location during a video conference visit in case a medical emergency arises during the visit. FDA considers real-time video interactions, including telemedicine, as a live exchange of information between the trial personnel and trial participants. These interactions are not considered electronic records and therefore are not subject to 21 CFR part 11. Q22. How does the COVID-19 public health emergency affect drug and biological product clinical trials required as postmarketing requirements (PMRs)? What about for required postmarket 

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