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Before Filing an IND
Components of the IND Part A
Components of the IND Part B
IND vocabulary
In what section of the IND is this?
100
The content and format of an IND is laid our in 21 Code of Federal Regulations (CFR) Part ________ and in numerous guidance documents published by the FDA.
What is 21 CFR Part 312.
100
This section contains a specific form that is required as part of the initial IND and every subsequent submission relating to the IND application. It also provides a section for the sponsor to state whether a contract research organization (CRO) will conduct any parts of the clinical study.
What is the Cover Sheet of the IND - FDA Form 1571. 21 CFR 312.23(a)(1)
100
This section describes the chemical structure and chemical properties of the compound, the composition, manufacturing process and control of the raw materials, drug substance, and drug product that ensure the identify, quality, purity and potentcy of the drug product. The ICH guidance refers to this as the Quality section of the IND.
What is the CMC (chemistry, manufacturing and controls) section of the IND. 21 CFR 312.23(a)(7)
100
This is a submission to the FDA that is used to provide confidential detailed information about processes, or articles used in manufacturing, processing, packaging, and storing of one or more human drugs.
What is the Drug Master File.
100
In this section, the sponsor should describe any differences between the drug product to be used in the proposed study and the drug product used in the nonclinical toxicology studies that support the clinical investigations. How these differences affect the safety profile should be discussed, and if there are no differences, those should be stated.
What is the CMC section.
200
An IND would be required to conduct a clinical trial if the drug is a new chemical entity, not approved for the indication under investigation, in a new dosage form, being administered at a new dosage level, and ___________________________________________.
What is a drug used in combination with another drug and the combination is not approved.
200
This section is a comprehensive listing of the contents of the IND broken down by section, volume, and page number. It should include all required sections, appendices, attachments, reports, and other reference material.
What is the IND Table of Contents. 21 CFR 312(a)(2)
200
This section describes the pharmacologic effects and mechinism of action of the drug and information on the absorption, distribution, metabolism, and excretion (ADME) of the drug. It also includes a 10-20 page summary of the toxicological findings from completed animal studies and in vitro studies.
What is the Pharmacology and Toxicology Information Section. 21 CFR 312.23(a)(8)
200
This is a brief report to the FDA on the progress of the clinical investigation. It is submitted each year within 60 days of the anniversary date that the IND went into effect.
What is the Annual Report.
200
Safety pharmacology studies, single dose and repeat dose toxicity studies, genotoxicity studies, and reproductive toxicity studies can be found in this section of the IND.
What is the Pharmacology and Toxicology Information section.
300
A 2004 final FDA guidance document states that these studies may be exempt from the IND requirements if there is scientific literature or other clinical experience available to support the proposed uses.
What are clinical studies on marketed cancer drugs.
300
This section begins with a description of the drug and the indication(s) to be studied and includes the pharmacologic class of the compound, the name of the drug and all active ingredients, the structural formula of the drug, the dosage form, and the route of administration. If if the drug was withdrawn from investigation or marketing in any country for safety reasons, the name of the country and the reason for withdrawal must be discussed. This section must also describe the sponsor's plan for investigating the drug and include the rational for the drug and the research study proposed, the general approach to be followed in studying the drug, the indication(s) to be studied, the type of clinical studies to be conducted, the estimated number of patients receiving the drug, the risks anticipated on the basis of nonclinical studies or prior studies in humans.
What is the IND Introductory Statement and General Investigational Plan of the IND. 21 CFR 312.23(a)(3)
300
This section presents data from previous trials that are relevant to the safety of the proposed investigation (e.g., PK and PD data, the observed AE profile in previous studies or other experiences and ADME data) and any information from previous trials on the drug's effectiveness for the proposed investigational use.
What is the Previous Human Experience section of the IND. 21 CFR 312(a)(9)
300
This is an order issued by the FDA to the sponsor to delay a proposed clinical investigation or to suspend ongoing investigations.
What is a clinical hold.
300
Drug dependence and abuse potential should be discussed in this section of the IND.
What is the Additional Information section of the IND.
400
The pre-IND meeting is considered a type __ meeting and should be scheduled within ____ days of the FDA's receipt of the written request for the meeting.
Whis is a type B meeting. Type B meetings should be scheduled within 60 days of the FDA's receipt of a written request for the meeting.
400
This section contains a key document provided to each clinical investigator and the IRB at each of the clinical sites. It presents the key nonclinical (safety), clinical, and CMC (quality) data that support the proposed clinical trial. It provides investigators with the information necessary to understand the rationale for the proposed trial and to make an unbiased risk-benefit assessment of the appropriateness of the proposed trial.
What is the Investigator's Brochure section of the IND. 21 CFR 312.23(a)(5)
400
This section is used to present information on special topics such as any plans the sponsor has for assessing the safety and efficacy of the drug in the pediatric population.
What is the Additional Information sections of the IND. 21 CFR 312.23(a)(10)
400
New data from animal studies, changes or additions to an IND's CMC section, or reports on discontinued clinical trials would be submitted through this type of amendment.
What is an Information Amendment.
400
If the investigational drug is marketed outside of the U.S., or was previously, a list of those countries should be provided as well as a list of any countries where the drug was withdrawn from marketing because of safety or efficacy issues. This information should be included in this section of the IND.
What is the Previous Human Experience section of the IND.
500
A ___________ document is required at least 4 weeks before a Pre-IND meeting. There are 3 other meetings that can be held during the IND phase including:
What is the briefing document. What are the end-of-phase 1 meeting (generally for fast track), End-of-phase II meeting, and Pre-NDA or pre-BLA meeting.
500
This section describes how a particular clinical trial is to be conducted. The required contents of this section include: 1. A statement of the objectives and purpose of the study; 2. The name, address, and qualifications of each investigator and each sub-investigator participating in the study; 3. Inclusion/exclusion criteria for study subjects and an estimate of the number of subjects to be enrolled in the study; 4. A description of the study design, control groups to be used, and the methods employed to minimize bias on the part of the subjects, investigators, and analysts; 5. The planned maximum dose, the duration of patient exposure to the drug, and the methods to be used to determine the dose to be administered. 6. A description of the measurements and observations to be made to achieve the study objectives, and 7. A description of the clinical procedures and laboratory tests planned to monitor the effects of the drug in the subjects.
What is the Clinical Protocal section of the IND. 21 CFR 312.23(a)(6)
500
It is common to place the meeting minutes from any pre-IND meeting or discussion in this section.
What is the Relevant Information section of the IND. 21 CFR 312.23(a)(11)
500
A sponsor must file this type of amendment when there is any increase in drug dosage or the duration of individual subject's exposure to the drug beyond that in the current protocol.
What is a Protocol Amendment.
500
A "systematic" presentation of the findings from the animal toxicokinetic studies presented by organ system (cardiovasucular, renal, hepatic, etc.) should be included in this section of the IND.
What is the Pharmacology and Toxicology Information section of the IND.