; or (ii) an effect on a clinical endpoint other than survival or irreversible morbidity of interest. (d) Transparency and patient monitoring requirements (1) Registries (A) In general The sponsor of a drug provisionally approved under this section shall require that all patients who use such drug participate in an observational registry and consent to the sponsor’s collection, and submission to the registry, of data related to the patient’s use of such drug until such drug receives approval under section 505 or section 351 of the Public Health Service Act, or the provisional approval is rescinded. (B) Requirements for registries An observational registry described in subparagraph (A) may be run by a third party, such as a government, for profit, or nonprofit organization, and shall track all patients who use the provisionally approved drug. (C) Accessibility An observational registry described in subparagraph (A) shall be easily accessible for— (i) all patients who are participating in any registry related to a provisionally approved drug that allows for easy, unrestricted (or transparent) access for such patients to their patient data and related information regarding their usage of the provisionally approved drug; and (ii) approved researchers and medical professionals who may access data maintained in the registry, which access shall be for public health research and only in a de-identified, aggregated manner. (2) Funding An observational registry under this subsection shall be maintained, as applicable— (A) by the sponsor of the drug provisionally approved under this section that is the subject of the registry; or (B) by a third party, such as a government, for profit, or nonprofit organization. (3) Sponsor requirements (A) In general For any drug application provisionally approved under this section, the Secretary shall notify the sponsor of the exact data such sponsor is required to submit to an observational registry. (B) Annual review of the registry