Document:USA 21 CFR Part 312 09-Apr-2025: Difference between revisions
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| Document information | |
|---|---|
| Reference | USA 21 CFR Part 312 09-Apr-2025 |
| Validity area | USA |
| Scope(s) | HM |
| Document name | 21 CFR Part 312 |
| Version / Revision | 09-Apr-2025 |
| Status | Current |
| Document type | Legal act |
| Language(s) | EN |
| Description | Title 21 โFood and Drugs
Chapter I โFood and Drug Administration, Department of Health and Human Services Subchapter DโDrugs for Human Use Part 312 Investigational New Drug Application https://www.ecfr.gov/current/title-21 |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
References
| Reference | Scope | Document part | Language | Preview |
|---|---|---|---|---|
| Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.3 - Clinical investigation | HM | ยง 312.3 - Clinical investigation | EN | Clinical investigation means any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects. For the purposes of this part, an experiment is any use of ... |
| Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.21 | HM | ยง 312.21 | EN | ยง 312.21 Phases of an investigation. An IND may be submitted for one or more phases of an investigation. The clinical investigation of a previously untested drug is generally divided into three ... |
| Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.85 | HM | ยง 312.85 | EN | ยง 312.85 Phase 4 studies. Concurrent with marketing approval, FDA may seek agreement from the sponsor to conduct certain postmarketing (phase 4) studies to delineate additional information about the ... |
| Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.23 (6) (d) | HM | ยง 312.23
(6) (d) || EN || ยง 312.23 IND content and format. [โฆ] (6) Protocols. [...] (d) A description of the design of the study, including the kind of control group to be used, if any, and a description of methods to be used ... | ||
| Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.3 - IEC | HM | ยง 312.3 - IEC | EN | Independent ethics committee (IEC) means a review panel that is responsible for ensuring the protection of the rights, safety, and well-being of human subjects involved in a clinical investigation ... |
| Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.40 (b) | HM | ยง 312.40
(b) || EN || ยง 312.40 General requirements for use of an investigational new drug in a clinical investigation. [โฆ] (b) An IND goes into effect: (1) Thirty days after FDA receives the IND, unless FDA notifies the ... | ||
| Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.62 | HM | ยง 312.62 | EN | ยง 312.62 Investigator recordkeeping and record retention. (a) Disposition of drug. An investigator is required to maintain adequate records of the disposition of the drug, including dates, quantity, ... |
| Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.57-001 | HM | ยง 312.57 | EN | ยง 312.57 recordkeeping and record retention. (a) A sponsor shall maintain adequate records showing the receipt, shipment, or other disposition of the investigational drug. These records are required ... |
| Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.23 (a) ; (6) | HM | ยง 312.23
(a) ; (6) || EN || ยง 312.23 IND content and format. (a) A sponsor who intends to conduct a clinical investigation subject to this part shall submit an โInvestigational New Drug Applicationโ (IND) including, in the ... | ||
| Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.23 (a) ; (5) | HM | ยง 312.23
(a) ; (5) || EN || ยง 312.23 IND content and format. (a) A sponsor who intends to conduct a clinical investigation subject to this part shall submit an โInvestigational New Drug Applicationโ (IND) including, in the ... | ||
| Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.3 (b) - Sponsor | HM | ยง 312.3
(b) - Sponsor || EN || [...] Sponsor means a person who takes responsibility for and initiates a clinical investigation. The sponsor may be an individual or pharmaceutical company, governmental agency, academic ... | ||
| Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.3 (b) - Sponsor-Investigator | HM | ยง 312.3
(b) - Sponsor-Investigator || EN || [...] Sponsor-Investigator means an individual who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed. The term ... | ||
| Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.3 (b) - CRO | HM | ยง 312.3
(b) - CRO || EN || [...] Contract research organization means a person that assumes, as an independent contractor with the sponsor, one or more of the obligations of a sponsor, e.g., design of a protocol, selection or ... | ||
| Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.50 | HM | ยง 312.50 | EN | ยง 312.50 General responsibilities of sponsors. Sponsors are responsible for selecting qualified investigators, providing them with the information they need to conduct an investigation properly, ... |
| Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.52 | HM | ยง 312.52 | EN | ยง 312.52 Transfer of obligations to a contract research organization. (a) A sponsor may transfer responsibility for any or all of the obligations set forth in this part to a contract research ... |
| Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.53 | HM | ยง 312.53 | EN | ยง 312.53 Selecting investigators and monitors. (a) Selecting investigators [โฆ] (b) Control of drug. [โฆ] (c) Obtaining information from the investigator. [...] (1) A signed investigator statement ... |
| Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.3 - Investigator | HM | ยง 312.3 - Investigator | EN | Investigator means an individual who actually conducts a clinical investigation (i.e., under whose immediate direction the drug is administered or dispensed to a subject). In the event an ... |
| Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.53 (c) (vi) | HM | ยง 312.53
(c) (vi) || EN || ยง 312.53 Selecting investigators and monitors. [โฆ] (c) [โฆ] (vi) A commitment by the investigator that he or she: (a) Will conduct the study(ies) in accordance with the relevant, current protocol(s) ... | ||
| Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.60-001 | HM | ยง 312.60 | EN | ยง 312.60 General responsibilities of investigators. An investigator is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational ... |
| Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.64-001 | HM | ยง 312.64 | EN | ยง 312.64 Investigator reports. (a) Progress reports. The investigator shall furnish all reports to the sponsor of the drug who is responsible for collecting and evaluating the results obtained. The ... |
| Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.53 (viii) | HM | ยง 312.53
(viii) || EN || ยง 312.53 Selecting investigators and monitors. [โฆ] (viii) A list of the names of the subinvestigators (e.g., research fellows, residents) who will be assisting the investigator in the conduct of the ... | ||
| Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.53 (c) | HM | ยง 312.53
(c) || EN || ยง 312.53 Selecting investigators and monitors. (c) Obtaining information from the investigator. Before permitting an investigator to begin participation in an investigation, the sponsor shall obtain ... | ||
| Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.60-002 | HM | ยง 312.60 | EN | ยง 312.60 General responsibilities of investigators. An investigator is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational ... |
| Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.23 (6) (c) - (d) | HM | ยง 312.23
(6) (c) - (d) || EN || ยง 312.23 IND content and format. [โฆ] (6) Protocols. [...] (c) The criteria for patient selection and for exclusion of patients and an estimate of the number of patients to be studied. (d) A ... | ||
| Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.6 - ยง312.8 ; ยง 312.10 | HM | ยง 312.6 - ยง312.8 ; ยง 312.10 | EN | [โฆ] ยง 312.6 Labeling of an investigational new drug. [โฆ] ยง 312.7 Promotion of investigational drugs. [โฆ] ยง 312.8 Charging for investigational drugs under an IND. [โฆ] ยง 312.10 Waivers. [โฆ] |
| Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.40 (c) (d) | HM | ยง 312.40
(c) (d) || EN || ยง 312.40 General requirements for use of an investigational new drug in a clinical investigation. [โฆ] (c) A sponsor may ship an investigational new drug to investigators named in the IND: (1) Thirty ... | ||
| Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.53 (b) | HM | ยง 312.53
(b) || EN || ยง 312.53 Selecting investigators and monitors. [โฆ] (b) Control of drug. A sponsor shall ship investigational new drugs only to investigators participating in the investigation. [โฆ] | ||
| Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.61 | HM | ยง 312.61 | EN | ยง 312.61 Control of the investigational drug. An investigator shall administer the drug only to subjects under the investigator's personal supervision or under the supervision of a subinvestigator ... |
| Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.62 (a) | HM | ยง 312.62
(a) || EN || ยง 312.62 Investigator recordkeeping and record retention. (a) Disposition of drug. An investigator is required to maintain adequate records of the disposition of the drug, including dates, quantity, ... | ||
| Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.69 | HM | ยง 312.69 | EN | ยง 312.69 Handling of controlled substances. If the investigational drug is subject to the Controlled Substances Act, the investigator shall take adequate precautions, including storage of the ... |
| Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.53 (c) (vi) - (vii) | HM | ยง 312.53
(c) (vi) - (vii) || EN || ยง 312.53 Selecting investigators and monitors. [โฆ] (c) [โฆ] (vi) A commitment by the investigator that he or she: (a) Will conduct the study(ies) in accordance with the relevant, current protocol(s) ... | ||
| Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.70 | HM | ยง 312.70 | EN | ยง 312.70 Disqualification of a clinical investigator. [โฆ] |
| Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.62 (b) | HM | ยง 312.62
(b) || EN || ยง 312.62 Investigator recordkeeping and record retention. [...] (b) Case histories. An investigator is required to prepare and maintain adequate and accurate case histories that record all ... | ||
| Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.53 (d) | HM | ยง 312.53
(d) || EN || ยง 312.53 Selecting investigators and monitors. [โฆ] (d) Selecting monitors. A sponsor shall select a monitor qualified by training and experience to monitor the progress of the investigation. | ||
| Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.30 | HM | ยง 312.30 | EN | ยง 312.30 Protocol amendments. [โฆ] (a) New protocol [โฆ] (b) Changes in a protocol. [โฆ] (c) New investigator [โฆ] (d) Content and format [โฆ] |
| Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.31 | HM | ยง 312.31 | EN | ยง 312.31 Information amendments. (a) Requirement for information amendment. A sponsor shall report in an information amendment essential information on the IND that is not within the scope of a ... |
| Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.58 | HM | ยง 312.58 | EN | ยง 312.58 Inspection of sponsor's records and reports. (a) FDA inspection. A sponsor shall upon request from any properly authorized officer or employee of the Food and Drug Administration, at ... |
| Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.68 | HM | ยง 312.68 | EN | ยง 312.68 Inspection of investigator's records and reports. An investigator shall upon request from any properly authorized officer or employee of FDA, at reasonable times, permit such officer or ... |
| Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.32 - Adverse event | HM | ยง 312.32 - Adverse event | EN | Adverse event means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. |
| Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.32 - Life-threatening Adverse event | HM | ยง 312.32 - Life-threatening Adverse event | EN | Life-threatening adverse event or life-threatening suspected adverse reaction. An adverse event or suspected adverse reaction is considered โlife-threateningโ if, in the view of either the ... |
| Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.32 - SAE | HM | ยง 312.32 - SAE | EN | Serious adverse event or serious suspected adverse reaction. An adverse event or suspected adverse reaction is considered โseriousโ if, in the view of either the investigator or sponsor, it results ... |
| Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.32 - Suspected adverse reaction | HM | ยง 312.32 - Suspected adverse reaction | EN | Suspected adverse reaction means any adverse event for which there is a reasonable possibility that the drug caused the adverse event. For the purposes of IND safety reporting, โreasonable ... |
| Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.32 - Unexpected adverse event | HM | ยง 312.32 - Unexpected adverse event | EN | Unexpected adverse event or unexpected suspected adverse reaction. An adverse event or suspected adverse reaction is considered โunexpectedโ if it is not listed in the investigator brochure or is not ... |
| Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.64 (b) | HM | ยง 312.64
(b) || EN || ยง 312.64 Investigator reports. [...] (b) Safety reports. An investigator must immediately report to the sponsor any serious adverse event, whether or not considered drug related, including those ... | ||
| Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.32 (b) | HM | ยง 312.32
(b) || EN || (b) Review of safety information. The sponsor must promptly review all information relevant to the safety of the drug obtained or otherwise received by the sponsor from foreign or domestic sources, ... | ||
| Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.32 (c) | HM | ยง 312.32
(c) || EN || (c) (1) IND safety reports. The sponsor must notify FDA and all participating investigators (i.e., all investigators to whom the sponsor is providing drug under its INDs or under any investigator's ... | ||
| Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.32 (d) | HM | ยง 312.32
(d) || EN || (d) Followup. (1) The sponsor must promptly investigate all safety information it receives. (2) Relevant followup information to an IND safety report must be submitted as soon as the information is ... | ||
| Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.33 (a) - (b) | HM | ยง 312.33
(a) - (b) || EN || ยง 312.33 Annual reports. A sponsor shall within 60 days of the anniversary date that the IND went into effect, submit a brief report of the progress of the investigation that includes: (a) Individual ... | ||
| Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.30 (b) (ii) | HM | ยง 312.30
(b) (ii) || EN || ยง 312.30 Protocol amendments [โฆ] (b) Changes in a protocol. [โฆ] (ii) Notwithstanding paragraph (b)(2)(i) of this section, a protocol change intended to eliminate an apparent immediate hazard to ... | ||
| Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.44 (d) | HM | ยง 312.44
(d) || EN || ยง 312.44 Termination. [โฆ] (d) Immediate termination of IND (d) Immediate termination of IND. Notwithstanding paragraphs (a) through (c) of this section, if at any time FDA concludes that continuation ... | ||
| Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.56 | HM | ยง 312.56 | EN | ยง 312.56 Review of ongoing investigations. [โฆ] (d) A sponsor who determines that its investigational drug presents an unreasonable and significant risk to subjects shall discontinue those ... |
| Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.38 | HM | ยง 312.38 | EN | ยง 312.38 Withdrawal of an IND. (a) At any time a sponsor may withdraw an effective IND without prejudice. (b) If an IND is withdrawn, FDA shall be so notified, all clinical investigations conducted ... |
| Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.42 | HM | ยง 312.42 | EN | ยง 312.42 Clinical holds and requests for modification. (a) General. A clinical hold is an order issued by FDA to the sponsor to delay a proposed clinical investigation or to suspend an ongoing ... |
| Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.44 | HM | ยง 312.44 | EN | ยง 312.44 Termination. (a) General [โฆ] (b) Grounds for termination โ [โฆ] (c) Opportunity for sponsor response. [โฆ] (d) Immediate termination of IND [โฆ] |
| Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.45 | HM | ยง 312.45 | EN | ยง 312.45 Inactive status. (a) If no subjects are entered into clinical studies for a period of 2 years or more under an IND, or if all investigations under an IND remain on clinical hold for 1 year ... |
| Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.57-002 | HM | ยง 312.57 | EN | ยง 312.57 Recordkeeping and record retention. (a) A sponsor shall maintain adequate records showing the receipt, shipment, or other disposition of the investigational drug. These records are required ... |
| Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.62 (c) | HM | ยง 312.62
(c) || EN || ยง 312.62 Investigator recordkeeping and record retention. [...] (c) Record retention. An investigator shall retain records required to be maintained under this part for a period of 2 years following ... | ||
| Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.33 | HM | ยง 312.33 | EN | ยง 312.33 Annual reports. A sponsor shall within 60 days of the anniversary date that the IND went into effect, submit a brief report of the progress of the investigation that includes: [โฆ] |
| Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.64-002 | HM | ยง 312.64 | EN | ยง 312.64 Investigator reports. (a) Progress reports. The investigator shall furnish all reports to the sponsor of the drug who is responsible for collecting and evaluating the results obtained. The ... |
| Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.64 (c) - (d) | HM | ยง 312.64
(c) - (d) || EN || ยง 312.64 Investigator reports. [...] (c) Final report. An investigator shall provide the sponsor with an adequate report shortly after completion of the investigator's participation in the ... | ||
| Reference:USA 21 CFR Part 312 09-Apr-2025 ยง 312.33 (a) (3) | HM | ยง 312.33
(a) (3) || EN || ยง 312.33 Annual reports. A sponsor shall within 60 days of the anniversary date that the IND went into effect, submit a brief report of the progress of the investigation that includes: [โฆ] (a) [โฆ] ... |
