Part 312 - Investigational New Drug Application Flashcards
What is the definition of an Investigational New Drug (IND) under 21 CFR Part 312.3?
A new drug or biological drug that is used in a clinical investigation. The term also includes a biological product that is used in vitro for diagnostic purposes.
What does 21 CFR Part 312.40 require regarding the submission of an IND?
An IND must be submitted and must go into effect before a clinical trial involving a new drug or biological product can begin.
Under 21 CFR Part 312.31, what information should be included in an Information Amendment?
New technical information that is not within the scope of a protocol amendment or IND safety report, including new toxicology, chemistry, or other technical information.
Describe the process for initial IND submission according to 21 CFR Part 312.20.
The sponsor must submit a detailed IND application that includes preclinical study results, manufacturing information, clinical protocols, investigator information, and commitments to comply with the IND regulations.
What are the responsibilities of investigators under 21 CFR Part 312.60?
Investigators must ensure that the investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations, and protect the rights, safety, and welfare of subjects.
What is the definition of a serious adverse event (SAE) under 21 CFR Part 312.32?
Any adverse event that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
According to 21 CFR Part 312.53, what must sponsors ensure when selecting investigators?
Sponsors must ensure that investigators are qualified by training and experience, and that they provide them with the necessary information to conduct the investigation properly.
What is the primary purpose of 21 CFR Part 312.41 regarding meetings with FDA?
To provide guidance on when and how sponsors can request meetings with the FDA to discuss the development and review of their IND.
How long must clinical trial records be retained according to 21 CFR Part 312.62(c)?
Records must be retained for 2 years following the date a marketing application is approved for the drug; if no application is filed or if the application is not approved, for 2 years after the investigation is discontinued and FDA is notified.
What constitutes a significant risk device under 21 CFR Part 312.3?
A device that presents a potential for serious risk to the health, safety, or welfare of a subject, such as those intended as an implant, those used in supporting or sustaining human life, and those of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health.
What is required in a protocol for a clinical trial as per 21 CFR Part 312.23(a)(6)?
A protocol must include a detailed plan for the clinical study, including objectives, design, methodology, statistical considerations, and organization of the trial, along with detailed information on the drug and its intended use.
What actions must be taken if a clinical hold is placed on an IND according to 21 CFR Part 312.42?
The sponsor must address the deficiencies noted by the FDA, and the clinical hold will remain until the FDA has been satisfied that the issues have been resolved.
What is the purpose of a Phase 1 clinical trial as defined by 21 CFR Part 312.21(a)?
To determine the metabolism and pharmacologic actions of the drug in humans, the side effects.
Describe the requirements for expedited safety reports under 21 CFR Part 312.32(c).
Expedited safety reports must be submitted within 15 calendar days after the sponsor determines that the information qualifies for reporting, including serious and unexpected adverse events.
According to 21 CFR Part 312.30, what constitutes a significant protocol amendment?
Changes to the study protocol that significantly affect the safety of subjects, the scope of the investigation, or the scientific quality of the study.
What must a sponsor do if they terminate an IND study prematurely as per 21 CFR Part 312.44(b)?
Notify the FDA and all participating investigators in writing, providing the reason for termination, and ensure that all subjects are adequately followed up.
Under 21 CFR Part 312.56, what are the sponsor’s obligations regarding monitoring?
Sponsors must monitor the progress of all clinical investigations being conducted under their IND and ensure compliance with the protocol and regulatory requirements.
What should be included in an IND Annual Report according to 21 CFR Part 312.33?
Summary of the progress of the investigation, including individual study information, summary of adverse experiences, and any significant changes to the study protocol or IND.
What is the purpose of a Treatment IND under 21 CFR Part 312.34?
To make investigational drugs available to patients with serious or immediately life-threatening diseases when there is no comparable or satisfactory alternative therapy available.
What constitutes adequate and well-controlled studies as per 21 CFR Part 312.21(b)?
Studies that are designed and conducted to provide a valid comparison with a control, which can be a placebo, active treatment, historical control, or no treatment, ensuring that the results are reliable and scientifically valid.
What must be included in a sponsor’s statement of investigator according to 21 CFR Part 312.53(c)?
The sponsor must include the investigator’s curriculum vitae or other statement of qualifications, signed investigator statement (Form FDA 1572), and financial disclosure information.
What is the purpose of 21 CFR Part 312.56(b) regarding protocol compliance?
Sponsors must ensure that all clinical investigations are conducted in accordance with the protocol and regulations, and must secure compliance or discontinue shipments of the investigational drug if investigators fail to comply.
Define “IND Safety Report” under 21 CFR Part 312.32.
An IND safety report is a notification to the FDA and all participating investigators of any adverse event that is serious, unexpected, and associated with the use of the drug.
What constitutes “adequate and well-controlled” studies under 21 CFR Part 312.21(b)?
Studies that provide a valid comparison with a control group, use appropriate methods to minimize bias, and are conducted by qualified investigators following a written protocol.
Describe the requirements for maintaining drug accountability records under 21 CFR Part 312.62(a).
Investigators must maintain accurate records of the receipt, use, and disposition of investigational drugs, including dates, quantities, and batch numbers.
What information must be included in an IND annual report as per 21 CFR Part 312.33?
A brief summary of the study’s progress, a summary of significant adverse events, any new risk information, and any changes in the study protocol or drug supply.
What are the FDA’s responsibilities in reviewing an IND application according to 21 CFR Part 312.40?
The FDA reviews the IND to ensure that subjects are not exposed to unreasonable risks and that the study design is appropriate to achieve its objectives.
What is the purpose of a Treatment IND as described in 21 CFR Part 312.34?
To allow access to investigational drugs for patients with serious or immediately life-threatening conditions when there are no comparable or satisfactory alternative treatments available.
Under 21 CFR Part 312.30, what is a protocol amendment?
A protocol amendment is a change to the study protocol that must be submitted to the FDA, including new investigator information, significant protocol modifications, or changes in the clinical trial design.
Define “serious adverse event” (SAE) according to 21 CFR Part 312.32.
An SAE is any adverse event that results in death, is life-threatening, requires hospitalization, results in significant disability/incapacity, or is a congenital anomaly/birth defect.
What should be included in an IND submission under 21 CFR Part 312.23?
General investigational plan, protocols, chemistry, manufacturing, control information, pharmacology and toxicology data, previous human experience, and additional required information.
Describe the process for initial IND submission according to 21 CFR Part 312.20.
Submit a detailed application including preclinical study results, manufacturing information, clinical protocols, investigator qualifications, and commitments to comply with regulations.
What actions must be taken if a clinical hold is placed on an IND under 21 CFR Part 312.42?
The sponsor must address the deficiencies noted by the FDA, and the clinical hold will remain until the FDA is satisfied that the issues have been resolved.
What are the responsibilities of investigators under 21 CFR Part 312.60?
Ensuring study conduct according to the signed investigator statement, the investigational plan, regulations, and protecting the rights, safety, and welfare of subjects.
What is the primary purpose of a Phase I clinical trial according to 21 CFR Part 312.21(a)?
To determine the metabolism and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and early evidence of effectiveness.
According to 21 CFR Part 312.32(c), what are the requirements for expedited safety reports?
Expedited safety reports must be submitted within 15 calendar days of the sponsor determining that the information qualifies for reporting, including serious and unexpected adverse events.
What is a “significant risk device” under 21 CFR Part 312.3?
A device that presents a potential for serious risk to the health, safety, or welfare of a subject, such as implants, life-supporting devices, or those important for diagnosing or treating serious conditions.
Describe the requirements for maintaining clinical trial records under 21 CFR Part 312.62(c).
Records must be retained for 2 years following the date a marketing application is approved for the drug, or if no application is filed, 2 years after the investigation is discontinued.
What must a sponsor do if an IND study is terminated prematurely as per 21 CFR Part 312.44(b)?
Notify the FDA and all participating investigators in writing, provide the reason for termination, and ensure all subjects are adequately followed up
Under 21 CFR Part 312.56, what are the sponsor’s obligations regarding monitoring?
Sponsors must monitor the progress of all clinical investigations under their IND and ensure compliance with the protocol and regulatory requirements.
