( A statement of the objectives and purpose of the study.
( The name and address and a statement of the qualifications (curriculum vitae or other statement of qualifications) of each investigator, and the name of each subinvestigator (e.g., research fellow, resident) working under the supervision of the investigator; the name and address of the research facilities to be used; and the name and address of each reviewing Institutional Review Board.
( The criteria for patient selection and for exclusion of patients and an estimate of the number of patients to be studied.
( 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 to minimize bias on the part of subjects, investigators, and analysts.
( The method for determining the dose(s) to be administered, the planned maximum dosage, and the duration of individual patient exposure to the drug.
( A description of the observations and measurements to be made to fulfill the objectives of the study.
( A description of clinical procedures, laboratory tests, or other measures to be taken to monitor the effects of the drug in human subjects and to minimize risk.
(Drug substance. A description of the drug substance, including its physical, chemical, or biological characteristics; the name and address of its manufacturer; the general method of preparation of the drug substance; the acceptable limits and analytical methods used to assure the identity, strength, quality, and purity of the drug substance; and information sufficient to support stability of the drug substance during the toxicological studies and the planned clinical studies. Reference to the current edition of the United States Pharmacopeia-National Formulary may satisfy relevant requirements in this paragraph.
(Drug product. A list of all components, which may include reasonable alternatives for inactive compounds, used in the manufacture of the investigational drug product, including both those components intended to appear in the drug product and those which may not appear but which are used in the manufacturing process, and, where applicable, the quantitative composition of the investigational drug product, including any reasonable variations that may be expected during the investigational stage; the name and address of the drug product manufacturer; a brief general description of the manufacturing and packaging procedure as appropriate for the product; the acceptable limits and analytical methods used to assure the identity, strength, quality, and purity of the drug product; and information sufficient to assure the product's stability during the planned clinical studies. Reference to the current edition of the United States Pharmacopeia-National Formulary may satisfy certain requirements in this paragraph.
( A brief general description of the composition, manufacture, and control of any placebo used in a controlled clinical trial.
(Labeling. A copy of all labels and labeling to be provided to each investigator.
(Environmental analysis requirements. A claim for categorical exclusion under §25.30 oror an environmental assessment under §25.40.
( For each toxicology study that is intended primarily to support the safety of the proposed clinical investigation, a full tabulation of data suitable for detailed review.
21 C.F.R. §312.23