; (B) the role of community partners or community institutional review boards in reviewing the plans; and (C) how the trial will recruit a study population that is— (i) in proportion to the prevalence of the disease or condition in such groups relative to the prevalence of the disease or condition in the overall population of the United States; (ii) in sufficient numbers to obtain clinically and statistically meaningful determinations of the safety and effectiveness of the drug, device, biological product, or behavioral intervention being studied in the respective race, ethnicity, age, and sex groups; and (iii) consistent with the guidance under section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(b)(1) ) and guidance issued by the National Institutes of Health on the inclusion of women and minorities in clinical trials; (4) the sponsor’s plan for implementing, or an explanation of why the sponsor cannot implement, alternative clinical trial follow-up requirements that are less burdensome for trial participants, such as— (A) requiring fewer follow-up visits; (B) allowing phone follow-up or home visits by nurse trial coordinators (in lieu of in-person visits by patients); (C) allowing for online follow-up options; (D) permitting the patient’s primary care provider to perform some of the follow-up visit requirements; (E) allowing for evening and weekend hours for required follow-up visits; (F) allowing virtual or telemedicine visits; (G) use of wearable technology to record key health parameters; and (H) use of alternate labs or imaging centers, which may be closer to the residence of the patients participating in the trial