Human Subjects Protections

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21 CFR § 312.1

Scope.

This provision defines the scope and applicability of regulations governing the use of investigational new drugs and the submission of investigational new drug applications to the FDA.

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21 CFR § 312.10

Waivers.

This provision outlines the process and criteria for sponsors to request waivers from FDA requirements for investigational new drugs, including emergency procedures.

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21 CFR § 312.110

Import and export requirements.

This provision specifies the conditions and certification requirements for importing and exporting investigational new drugs for clinical investigations.

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21 CFR § 312.120

Foreign clinical studies not conducted under an IND.

This provision establishes the conditions under which the FDA accepts foreign clinical study data, including requirements for good clinical practice and record retention.

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21 CFR § 312.130

Availability for public disclosure of data and information in an IND.

This provision outlines the requirements for the public disclosure of data and information contained within an Investigational New Drug application.

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21 CFR § 312.160

Drugs for investigational use in laboratory research animals or in vitro tests.

This provision establishes requirements for the shipment, labeling, and record-keeping of drugs intended solely for laboratory research or in vitro testing.

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21 CFR § 312.2

Applicability.

This provision defines the scope of the Investigational New Drug regulations and identifies specific exemptions for certain clinical investigations.

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21 CFR § 312.20

Requirement for an IND.

This provision mandates the submission of an Investigational New Drug application to the FDA before initiating a clinical investigation.

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21 CFR § 312.21

Phases of an investigation.

This provision defines the three phases of clinical investigations for investigational new drugs.

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21 CFR § 312.22

General principles of the IND submission.

This provision outlines the FDA's objectives and expectations for the content and format of Investigational New Drug submissions.

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21 CFR § 312.23

IND content and format.

This provision outlines the required content, format, and submission standards for an Investigational New Drug (IND) application, including protocols, investigator brochures, and safety data for clinical investigations.

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21 CFR § 312.3

Definitions and interpretations.

This provision defines key terms used in investigational new drug applications, including clinical investigation, sponsor, investigator, and human subject.

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21 CFR § 312.30

Protocol amendments.

Once an IND is in effect, a sponsor shall amend it as needed to ensure that the clinical investigations are conducted according to protocols included in the application.

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21 CFR § 312.300

General.

This provision outlines the scope and definitions for the use of investigational new drugs and REMS-restricted drugs for patients with serious or life-threatening conditions.

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21 CFR § 312.305

Requirements for all expanded access uses.

This provision establishes the criteria, submission requirements, and investigator responsibilities for all expanded access uses of investigational drugs.

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21 CFR § 312.31

Information amendments.

This provision mandates that sponsors report essential new technical information, such as toxicology or chemistry data, via information amendments to the FDA.

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21 CFR § 312.310

Individual patients, including for emergency use.

This provision details the criteria and procedures for using investigational drugs for individual patients, including emergency authorization protocols.

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21 CFR § 312.315

Intermediate-size patient populations.

Under this section, FDA may permit an investigational drug to be used for the treatment of a patient population smaller than that typical of a treatment IND or treatment protocol.

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21 CFR § 312.32

IND safety reporting.

This regulation establishes requirements for sponsors to review, investigate, and report serious and unexpected suspected adverse reactions occurring during clinical investigations of investigational new drugs.

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21 CFR § 312.320

Treatment IND or treatment protocol.

Under this section, FDA may permit an investigational drug to be used for widespread treatment use.

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21 CFR § 312.33

Annual reports.

Sponsors must submit an annual report detailing the progress of clinical investigations, including study status, subject data, and safety information.

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21 CFR § 312.38

Withdrawal of an IND.

Sponsors may withdraw an IND at any time, but must notify the FDA, investigators, and IRBs if the withdrawal is due to safety concerns.

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21 CFR § 312.40

General requirements for use of an investigational new drug in a clinical investigation.

Clinical investigations may proceed once an IND is in effect, provided the sponsor and investigators comply with all applicable FDA regulations and IRB requirements.

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21 CFR § 312.41

Comment and advice on an IND.

The FDA may provide advisory comments or advice to sponsors regarding IND deficiencies or study design, which are distinct from formal clinical hold orders.

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21 CFR § 312.42

Clinical holds and requests for modification.

This regulation outlines the criteria and procedures under which the FDA may issue a clinical hold on an investigational new drug study to protect human subjects or address protocol deficiencies.

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21 CFR § 312.44

Termination.

This provision outlines the procedures and grounds under which the FDA may terminate an Investigational New Drug (IND) application, including requirements for sponsor response and immediate termination for safety risks.

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21 CFR § 312.45

Inactive status.

This provision defines the criteria and procedures for placing an Investigational New Drug (IND) application on inactive status, including requirements for resuming clinical investigations.

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21 CFR § 312.47

Meetings.

This provision describes the purpose, timing, and conduct of meetings between sponsors and the FDA during the drug investigation process, including end-of-phase 2 and pre-NDA meetings.

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21 CFR § 312.48

Dispute resolution.

This provision establishes procedures for resolving administrative, procedural, scientific, and medical disputes between sponsors and the FDA regarding IND requirements.

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21 CFR § 312.50

General responsibilities of sponsors.

This provision outlines the general responsibilities of sponsors in clinical investigations, including selecting qualified investigators, monitoring investigations, and ensuring compliance with protocols and safety reporting.

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21 CFR § 312.52

Transfer of obligations to a contract research organization.

This provision specifies the requirements for transferring sponsor obligations to a contract research organization (CRO) and the resulting regulatory accountability for the CRO.

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21 CFR § 312.53

Selecting investigators and monitors.

Sponsors must select qualified investigators and monitors, obtain signed investigator statements, and maintain clinical protocols and financial disclosure information for investigational drug studies.

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21 CFR § 312.54

Emergency research under § 50.24 of this chapter.

Sponsors must monitor emergency research investigations involving exceptions from informed consent and report IRB determinations to the FDA.

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21 CFR § 312.55

Informing investigators.

Sponsors are required to provide investigators with an investigator brochure and keep them updated on new safety information and adverse effects throughout the investigation.

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21 CFR § 312.56

Review of ongoing investigations.

Sponsors must monitor clinical investigations, ensure investigator compliance, evaluate safety data, and discontinue studies that present unreasonable risks to subjects.

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21 CFR § 312.57

Recordkeeping and record retention.

Sponsors must maintain accurate records of investigational drug disposition, financial interests of investigators, and retain these records for specified periods.

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21 CFR § 312.58

Inspection of sponsor's records and reports.

Sponsors must permit FDA inspection of records and reports and ensure secure storage for controlled substances used in investigations.

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21 CFR § 312.59

Disposition of unused supply of investigational drug.

Sponsors must ensure the return or authorized alternative disposition of unused investigational drugs when an investigator's participation ends.

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21 CFR § 312.60

General responsibilities of investigators.

Investigators are responsible for conducting studies according to protocols, protecting subject rights and safety, and obtaining informed consent.

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21 CFR § 312.61

Control of the investigational drug.

Investigators must personally supervise the administration of investigational drugs and ensure they are not supplied to unauthorized persons.

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21 CFR § 312.62

Investigator recordkeeping and record retention.

Investigators must maintain accurate records of drug disposition and case histories for all subjects participating in clinical investigations.

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21 CFR § 312.64

Investigator reports.

Investigators are required to submit progress, safety, and financial disclosure reports to the sponsor during clinical investigations.

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21 CFR § 312.66

Assurance of IRB review.

Investigators must ensure that an Institutional Review Board provides initial and continuing oversight for all clinical study activities.

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21 CFR § 312.68

Inspection of investigator's records and reports.

Investigators must permit authorized FDA personnel to access and verify records and reports related to clinical investigations.

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21 CFR § 312.69

Handling of controlled substances.

Investigators must store investigational drugs subject to the Controlled Substances Act in a secure, locked enclosure to prevent theft or diversion.

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21 CFR § 312.7

Promotion of investigational drugs.

Sponsors and investigators are prohibited from promoting or commercially distributing investigational drugs before they are approved for commercial use.

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21 CFR § 312.70

Disqualification of a clinical investigator.

FDA may disqualify a clinical investigator who repeatedly or deliberately fails to comply with regulatory requirements or submits false information.

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21 CFR § 312.8

Charging for investigational drugs under an IND.

Sponsors must obtain FDA authorization and meet specific criteria to charge for investigational drugs used in clinical trials or expanded access.

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21 CFR § 312.80

Purpose.

This provision establishes the purpose of expediting the development and evaluation of new therapies for life-threatening or severely debilitating illnesses while maintaining safety and effectiveness standards.

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21 CFR § 312.81

Scope.

This provision defines the terms life-threatening and severely debilitating in the context of expedited drug development and clinical research.