Filing and Forms
Filing an IND/IDE application and preparation assistance
The FDA has set forth a specific format an IND application must follow. The IND Specialist will help in compiling an IND application and help the investigator assure that all the necessary documents are included.
The necessary documents needed to compile an IND include:
- Form FDA-1571: The Investigational New Drug Application Form
- Form FDA-1572: The Statement of Investigator Form
- Medwatch Mandatory Reporting Form
- Form FDA-3674
- Cover Letter
- Study Protocol (IRB Submission)
- Case Report Forms, or CRFs, are protocol-specific forms used to collect data for your research: The Protocol Development and Facilitation Office, at 212-327-7886, Donna.Brassil@rockefeller.edu, provides assistance in designing Case Report Forms. You may contact the IND Specialist at 212-327-7408, Kimberly.Bazylewicz@rockefeller.edu to coordinate all the activities related to your IND application.
- Additional Documents needed to compile an IND
- Introductory Statement: This is background information intended to place the development plan for the drug into perspective and help the FDA understand the study hypothesis.
- A General Investigational Plan: This is a brief statement describing the general steps that will be carried out in order to perform this study.
- Investigational Brochure: An investigational brochure is not applicable for a sponsor-investigator application. If a drug is being cross-referenced under an existing IND, the investigator can request to cross-reference the data from the existing application. This usually involves receiving a letter from the Sponsor granting permission to the FDA to review information on file. Generally an investigator's brochure contains the following:
- A description of the drug substance and the formulation
- Summary of the pharmacological and toxicological effects of the drug in animals an humans (if known)
- The pharmacokinetics and biological disposition of the drug in animals and in humans (if known)
- Information regarding the safety and effectiveness in humans obtained from prior clinical studies.
- Description of possible risks and side effects expected based on previous experience with the investigational drug or related drugs
- Any precautions or special monitoring needed as part of the investigational use of the drug
- Informed Consent: Process and documentation of information provided to the research subject explaining the study, procedures, risks, benefits, alternative treatment, compensation and confidentiality. Informed consent is documented in a written, signed, and dated form. The IRB requires use of the Informed Consent Template.
- IRB Approval Letter: The protocol must be approved by the institutional review board before it can be submitted to the FDA. The IRB will not grant final approval of an IND requiring protocol until it has been reviewed by the FDA. This paradox is managed by the institutional review board by issuing an approval with the stipulation that conduct of the protocol cannot begin until the protocol has been submitted to the FDA and either 1) the investigator has satisfied the FDA's additional requirements, or 2) the 30 days has elapsed from the date of receipt of the IND submission by the FDA and no clinical hold or other requirements have been issues.
- Chemistry, Manufacturing and Controls Data: Sufficient information to assure the proper identification, quality, purity and strength of the investigational drug. If the drug is legally marketed in the U.S., this should be stated.
- Investigational Drug Labeling: All investigational new drugs must be labeled with a warning stating "caution new drug for investigational use only."
- Environmental Assessment: How will your research or study affect the environment? Additional GMP and GLP requirements will apply if the compound is made on campus.
- Pharmacology and Toxicology Data:Information that describes the mechanism of action of the drugs, its toxicological effect and its pharmacological effects (Absorption, distribution, metabolism and excretion-ADME) in animal and in vitro.
- Previous Human Experience: (Articles cited in the study protocol)
- Form FDA-1571: The Investigational New Drug Application Form
- Form FDA-1572: The Statement of Investigator Form
- Medwatch Mandatory Reporting Form
- Form FDA-3674
Once the IND Application has been compiled as above, and submitted to the FDA Central Documents Office, the FDA will respond within 30 days with an acknowledgement letter and an IND number. This means that the IND has been successfully filed, however, the clinical investigation may not start until 30 days after the IND has been received by the FDA, unless earlier notification by FDA is received, stating, that the studies may begin.
After this acknowledgment, and within the 30 day window, the FDA may respond in one of three ways:
- The FDA may request additional information and may place clinical holds on your study or research. The study cannot begin until all concerns raised by the FDA have been addressed in ways acceptable to the FDA.
- The FDA may conclude that your project is exempt. An exemption means that the study or research may be conducted without filing an IND application.
- If there is no clinical hold placed on the study, and no further requirements are issued from the FDA after 30 days have elapsed, and the IRB approval is in place, the study may begin.
After approval of an IND, the Sponsor-Investigator is subject to the responsibilities set forth by the FDA for the sponsor/investigator of clinical trials.
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Contact Us: IND Specialist/Monitor 212-327-7408 or Kimberly.Bazylewicz@rockefeller.edu
