Editorial Note on Part 312
Editorial Note: Nomenclature changes to part 312 appear at 69 FR 13717, Mar. 24, 2004.

§ 312.120 Foreign clinical studies not conducted under an IND. ( a ) *Acceptance of studies.* ( 1 ) FDA will accept as support for an IND or application for marketing approval (an application under section 505 of the act or section 351 of the Public Health Service Act (the PHS Act) (42 U.S.C. 262)) a well-designed and well-conducted foreign clinical study not conducted under an IND, if the following conditions are met: ( i ) The study was conducted in accordance with good clinical practice (GCP). For the purposes of this section, GCP is defined as a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials in a way that provides assurance that the data and reported results are credible and accurate and that the rights, safety, and well-being of trial subjects are protected. GCP includes review and approval (or provision of a favorable opinion) by an independent ethics committee (IEC) before initiating a study, continuing review of an ongoing study by an IEC, and obtaining and documenting the freely given informed consent of the subject (or a subject's legally authorized representative, if the subject is unable to provide informed consent) before initiating a study. GCP does not require informed consent in life-threatening situations when the IEC reviewing the study finds, before initiation of the study, that informed consent is not feasible and either that the conditions present are consistent with those described in § 50.23 or § 50.24(a) of this chapter, or that the measures described in the study protocol or elsewhere will protect the rights, safety, and well-being of subjects; and
( ii ) FDA is able to validate the data from the study through an onsite inspection if the agency deems it necessary.
( 2 ) Although FDA will not accept as support for an IND or application for marketing approval a study that does not meet the conditions of paragraph (a)(1) of this section, FDA will examine data from such a study.
( 3 ) Marketing approval of a new drug based solely on foreign clinical data is governed by § 314.106 of this chapter.
( b ) *Supporting information.* A sponsor or applicant who submits data from a foreign clinical study not conducted under an IND as support for an IND or application for marketing approval must submit to FDA, in addition to information required elsewhere in parts 312, 314, or 601 of this chapter, a description of the actions the sponsor or applicant took to ensure that the research conformed to GCP as described in paragraph (a)(1)(i) of this section. The description is not required to duplicate information already submitted in the IND or application for marketing approval. Instead, the description must provide either the following information or a cross-reference to another section of the submission where the information is located: ( 1 ) The investigator's qualifications;
( 2 ) A description of the research facilities;
( 3 ) A detailed summary of the protocol and results of the study and, should FDA request, case records maintained by the investigator or additional background data such as hospital or other institutional records;
( 4 ) A description of the drug substance and drug product used in the study, including a description of the components, formulation, specifications, and, if available, bioavailability of the specific drug product used in the clinical study;
( 5 ) If the study is intended to support the effectiveness of a drug product, information showing that the study is adequate and well controlled under § 314.126 of this chapter;
( 6 ) The name and address of the IEC that reviewed the study and a statement that the IEC meets the definition in § 312.3 of this chapter. The sponsor or applicant must maintain records supporting such statement, including records of the names and qualifications of IEC members, and make these records available for agency review upon request;
( 7 ) A summary of the IEC's decision to approve or modify and approve the study, or to provide a favorable opinion;
( 8 ) A description of how informed consent was obtained;
( 9 ) A description of what incentives, if any, were provided to subjects to participate in the study;
( 10 ) A description of how the sponsor(s) monitored the study and ensured that the study was carried out consistently with the study protocol; and
( 11 ) A description of how investigators were trained to comply with GCP (as described in paragraph (a)(1)(i) of this section) and to conduct the study in accordance with the study protocol, and a statement on whether written commitments by investigators to comply with GCP and the protocol were obtained. Any signed written commitments by investigators must be maintained by the sponsor or applicant and made available for agency review upon request.
( c ) *Waivers.* ( 1 ) A sponsor or applicant may ask FDA to waive any applicable requirements under paragraphs (a)(1) and (b) of this section. A waiver request may be submitted in an IND or in an information amendment to an IND, or in an application or in an amendment or supplement to an application submitted under part 314 or 601 of this chapter. A waiver request is required to contain at least one of the following: ( i ) An explanation why the sponsor's or applicant's compliance with the requirement is unnecessary or cannot be achieved;
( ii ) A description of an alternative submission or course of action that satisfies the purpose of the requirement; or
( iii ) Other information justifying a waiver.
( 2 ) FDA may grant a waiver if it finds that doing so would be in the interest of the public health.
( d ) *Records.* A sponsor or applicant must retain the records required by this section for a foreign clinical study not conducted under an IND as follows: ( 1 ) If the study is submitted in support of an application for marketing approval, for 2 years after an agency decision on that application;
( 2 ) If the study is submitted in support of an IND but not an application for marketing approval, for 2 years after the submission of the IND.
[73 FR 22815, Apr. 28, 2008]