--- title: "Module 1: Admin information" slug: "module-1-admin-information-1" updated: 2025-05-01T19:26:45Z published: 2025-05-01T19:26:45Z canonical: "bgtcplaybook.document360.io/module-1-admin-information-1" --- > ## Documentation Index > Fetch the complete documentation index at: https://bgtcplaybook.document360.io/llms.txt > Use this file to discover all available pages before exploring further. # Module 1: Admin information The eCTD is the standardized format for marketing applications as established by the International Conference on Harmonization (ICH) and accepted by the EU, US, Japan, and many other countries. With minor exceptions, this enables consistent IND content and format requirements among ICH-adopting countries. Module 1, being the exception, does not follow the ICH format as the module is almost entirely comprised of local requirements and covers regional administrative information required by the applicable regulatory authority – in your case, the US FDA. ## Module 1.1: Forms 1571 and 3674 Forms 1571 and 3674 should accompany your IND. You can find the most current version of these forms on the FDA website here: [Forms | FDA](https://www.fda.gov/about-fda/reports-manuals-forms/forms). Each form serves a unique purpose in the IND application: - Form FDA 1571 – general information on the sponsor, description of the drug, type of submission and submission contents - Form 3674 – to certify compliance with ClinicalTrials.gov requirements ## Module 1.2: Cover letter This is typically a summary of the IND and serves as an introduction to the drug and contents of the submission. The IND cover letter is an important component of the IND submission and should clearly and effectively communicate the key points of the submission to the FDA. Consider including the following: - A description of the drug being studied - The purpose of the study and an overview of the study design - A statement indicating each study’s compliance with all applicable FDA regulations and guidelines ## Module 1.12.14: Environmental analysis waiver #### What is an Environmental analysis waiver?

Environmental impact considerations are covered under CFR 21 Part 25 [1]. The Environmental Analysis Waiver (EAW) process is used by the FDA in compliance with the National Environmental Policy Act (NEPA), which requires federal agencies to consider the environmental effects of their proposed actions. The FDA may determine that an EAW is appropriate for certain actions, such as the approval of new drug applications or medical devices, or the issuance of certain guidance documents. The waiver allows the agency to forgo a formal environmental analysis if it determines that such an analysis is unnecessary.

 #### So how does the waiver process work? Most INDs will be exempt from a formal environmental analysis, so a statement must be included, for example: “A categorical exclusion from the requirements of preparing an environmental assessment is claimed for this Investigational New Drug application under [21 CFR 25.31 (e)](https://www.ecfr.gov/current/title-21/part-25/section-25.31#p-25.31(e)). The drug to be shipped under this notice is intended to be used for clinical studies and/or research programs in which waste disposal will be controlled, the amount of waste expected to enter the environment is reasonably expected to be nontoxic and in minimal quantities, and to the knowledge of the applicant no extraordinary circumstances exist [(21 CFR 25.15 (d)](https://www.ecfr.gov/current/title-21/part-25/section-25.15#p-25.15(d))).” Other similar language may be appropriate. The exemption may not apply to all drugs (e.g., radioactive drugs) so additional analysis on the environmental impact may be necessary. #### Environmental analysis outside the United States As previously noted, Module 1 will contain different regional requirements. The European Union and specific European countries will have different environmental assessment requirements specific to AAVs and other gene therapy-based drugs. These products are considered “genetically modified organisms” (GMO) and the Ministry of Environment for the relevant countries requires specific format and content for the Environmental Analysis to be reviewed. If your general investigational plan includes study sites in Europe, you may need to consider these requirements. Please refer to this [link](https://health.ec.europa.eu/medicinal-products/advanced-therapies/genetically-modified-organism-gmo-aspects-investigational-medicinal-products_en) for more information. [[4]](/v1/docs/ref-ind-submission#module-1) ## Module 1.12.1: Pre-IND correspondence The Pre-IND meeting minutes issued by the FDA should be provided in this section. Any data or information requested by the FDA in the Pre-IND meeting may also be referenced in this section pointing to the module where the information is provided. ## Module 1.14.4.1: Investigator’s Brochure The purpose of the Investigator’s Brochure (IB) is to provide the investigator with clinical and non-clinical information about the investigational drug relevant to the study of the drug in human subjects. The IB contains summaries of non-clinical, CMC, and clinical information regarding the investigational drug, which can be used by investigators to understand the scientific basis for the treatment and its safety profile. Please refer to the [IB template](/v1/docs/module-1-admin-information-1#templates) to learn more about the information to include. ## Module 1.14.4.2: Investigational drug label The purpose of the investigational drug label is to provide a copy of all labels and labeling for the investigational product (both drug product and diluent, if applicable). A mock-up or printed representation of the proposed labeling for the investigator(s) is acceptable. The United States requires that investigational drug labels contain a "caution" statement that reads: "Caution: New Drug - Limited by Federal (or United States) law to investigational use." ## Module 1.20: General investigational plan For this section, you will provide an outline of the proposed clinical investigation plan of the drug. This includes both current and future studies. Your general investigational plan must summarize the following: - Rationale supporting the proposed clinical trial (including the dose, schedule, and patient population) - The planned trial duration - Indication(s) to be investigated - General approach for evaluation of the investigational drug - Twelve-month clinical development plan - Estimated number of subjects to be exposed in the trial - Any serious risks anticipated Now that you are done with Module 1, let’s get into Module 2, which contains summary documents. ## Templates - [](https://cdn.document360.io/a7cea773-7486-41ac-bd50-afa0255ce01f/Images/Documentation/INVESTIGATOR'S BROCHURE_template.docx)INVESTIGATOR'S BROCHURE_template44.05 KB[](https://cdn.document360.io/a7cea773-7486-41ac-bd50-afa0255ce01f/Images/Documentation/INVESTIGATOR'S BROCHURE_template.docx) - [](https://cdn.document360.io/a7cea773-7486-41ac-bd50-afa0255ce01f/Images/Documentation/GENERAL INVESTIGATIONAL PLAN_Template .docx)GENERAL INVESTIGATIONAL PLAN_Template29.38 KB[](https://cdn.document360.io/a7cea773-7486-41ac-bd50-afa0255ce01f/Images/Documentation/GENERAL INVESTIGATIONAL PLAN_Template .docx) Electronic Common Technical Document (eCTD) - The standard format for submitting applications, amendments, supplements, and reports to FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER). Investigational New Drug Application (IND) - An Investigational New Drug Application (IND) is a request for authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans. An IND must be authorized prior to interstate shipment and administration of any new drug or biological product that is not the subject of an approved New Drug Application or Biologics/Product License Application. Chemistry, Manufacturing, and Controls (CMC) - Crucial activities when developing new pharmaceutical products. CMC involves defining manufacturing practices and product specifications that must be followed and met in order to ensure product safety and consistency between batches.