responsible party

(1) Definitions; requirement (A) Definitions In this subsection: (i) Applicable clinical trial The term “applicable clinical trial” means an applicable device clinical trial or an applicable drug clinical trial. (ii) Applicable device clinical trial The term “applicable device clinical trial” means— (I) a prospective clinical study of health outcomes comparing an intervention with a device subject to section 360(k), 360e, or 360j(m) of title 21 against a control in human subjects (other than a small clinical trial to determine the feasibility of a device, or a clinical trial to test prototype devices where the primary outcome measure relates to feasibility and not to health outcomes); and (II) a pediatric postmarket surveillance as required under section 360l of title 21. (iii) Applicable drug clinical trial (I) In general The term “applicable drug clinical trial” means a controlled clinical investigation, other than a phase I clinical investigation, of a drug subject to section 355 of title 21 or to section 262 of this title . (II) Clinical investigation For purposes of subclause (I), the term “clinical investigation” has the meaning given that term in section 312.3 of title 21, Code of Federal Regulations (or any successor regulation). (III) Phase I For purposes of subclause (I), the term “phase I” has the meaning given that term in section 312.21 of title 21, Code of Federal Regulations (or any successor regulation). (iv) Clinical trial information The term “clinical trial information” means, with respect to an applicable clinical trial, those data elements that the responsible party is required to submit under paragraph (2) or under paragraph (3). (v) Completion date The term “completion date” means, with respect to an applicable clinical trial, the date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical trial concluded according to the prespecified protocol or was terminated. (vi) Device The term “device” means a device as defined in section 321(h) of title 21 . (vii) Drug The term “drug” means a drug as defined in section 321(g) of title 21 or a biological product as defined in section 262 of this title . (viii) Ongoing The term “ongoing” means, with respect to a clinical trial of a drug or a device and to a date, that— (I) 1 or more patients is enrolled in the clinical trial; and (II) the date is before the completion date of the clinical trial. (ix) Responsible party The term “responsible party”, with respect to a clinical trial of a drug or device, means— (I) the sponsor of the clinical trial (as defined in section 50.3 of title 21, Code of Federal Regulations (or any successor regulation)); or (II) the principal investigator of such clinical trial if so designated by a sponsor, grantee, contractor, or awardee, so long as the principal investigator is responsible for conducting the trial, has access to and control over the data from the clinical trial, has the right to publish the results of the trial, and has the ability to meet all of the requirements under this subsection for the submission of clinical trial information. (B) Requirement The Secretary shall develop a mechanism by which the responsible party for each applicable clinical trial shall submit the identity and contact information of such responsible party to the Secretary at the time of submission of clinical trial information under paragraph (2).

Source

42 USC § 282(j)(1)


Scoping language

None identified. Default scope is assumed to be the entire title.
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