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General Resources For Formatting An IND

Templates, and examples organized by CTD module and section

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Resource Name Description Type Source Date Issued Download
Module 1.3.1: Contact Information for Sponsor m1.3.1_contact_sponsor_information.docx Template SCGE
Module 1.7.1: Fast Track Designation Request m1.7.1_fast_track_designation_request.docx Template SCGE
Module 1.12.2: Request to Charge for a Clinical Trial m1.12.2_request_to_charge_clinical_trial.docx Template SCGE
Module 1.12.3: Request to Charge for Expanded Access m1.12.3_request_to_charge_expanded_access.docx Template SCGE
Module 1.12.5: Request for a Waiver m1.12.5_request_for_waiver.docx Template SCGE
Module 1.12.14: Environmental Analysis m1.12.14_environmental_analysis.docx Template SCGE
Module 1.14.4.1: Investigator's Brochure m1.14.4.1_investigators_brochure.docx Template SCGE
Module 1.14.4.2: Investigational Drug Labeling m1.14.4.2_investigational_drug_labeling.docx Template SCGE
Module 1.20: General Investigational Plan m1.20_general_investigational_plan.docx Template SCGE
Resource Name Description Type Source Date Issued Download
m2.2_introduction.docx m2.2_introduction.docx Template SCGE
m2.2_introduction.docx m2.2_introduction.docx Template SCGE
m2.3_quality_overall_summary.docx m2.3_quality_overall_summary.docx Template SCGE
m2.3_quality_overall_summary.docx m2.3_quality_overall_summary.docx Template SCGE
m2.3.A.1_facilities_equipment.docx m2.3.A.1_facilities_equipment.docx Template SCGE
m2.3.A.1_facilities_equipment.docx m2.3.A.1_facilities_equipment.docx Template SCGE
m2.3.A.2_adventitious_agents.docx m2.3.A.2_adventitious_agents.docx Template SCGE
m2.3.A.2_adventitious_agents.docx m2.3.A.2_adventitious_agents.docx Template SCGE
m2.3.A.3_novel_excipients.docx m2.3.A.3_novel_excipients.docx Template SCGE
m2.3.A.3_novel_excipients.docx m2.3.A.3_novel_excipients.docx Template SCGE
m2.3_qos_introduction.docx m2.3_qos_introduction.docx Template SCGE
m2.3_qos_introduction.docx m2.3_qos_introduction.docx Template SCGE
m2.3_qos_drug_product.docx m2.3_qos_drug_product.docx Template SCGE
m2.3_qos_drug_product.docx m2.3_qos_drug_product.docx Template SCGE
m2.3.R_regional_information.docx m2.3.R_regional_information.docx Template SCGE
m2.3.R_regional_information.docx m2.3.R_regional_information.docx Template SCGE
m2.3_qos_drug_substance.docx m2.3_qos_drug_substance.docx Template SCGE
m2.3_qos_drug_substance.docx m2.3_qos_drug_substance.docx Template SCGE
m2.4_nonclinical_overview.docx m2.4_nonclinical_overview.docx Template SCGE
m2.4_nonclinical_overview.docx m2.4_nonclinical_overview.docx Template SCGE
m2.5_clinical_overview.docx m2.5_clinical_overview.docx Template SCGE
m2.5_clinical_overview.docx m2.5_clinical_overview.docx Template SCGE
m2.6.1_introduction.docx m2.6.1_introduction.docx Template SCGE
m2.6.1_introduction.docx m2.6.1_introduction.docx Template SCGE
m2.6.2_pharmacology_written_summary.docx m2.6.2_pharmacology_written_summary.docx Template SCGE
m2.6.2_pharmacology_written_summary.docx m2.6.2_pharmacology_written_summary.docx Template SCGE
m2.6.3_pharmacology_tabulated_summary.docx m2.6.3_pharmacology_tabulated_summary.docx Template SCGE
m2.6.3_pharmacology_tabulated_summary.docx m2.6.3_pharmacology_tabulated_summary.docx Template SCGE
m2.6.4_pharmacokinetics_written_summary.docx m2.6.4_pharmacokinetics_written_summary.docx Template SCGE
m2.6.4_pharmacokinetics_written_summary.docx m2.6.4_pharmacokinetics_written_summary.docx Template SCGE
m2.6.5_pharmacokinetics_tabulated_summary.docx m2.6.5_pharmacokinetics_tabulated_summary.docx Template SCGE
m2.6.5_pharmacokinetics_tabulated_summary.docx m2.6.5_pharmacokinetics_tabulated_summary.docx Template SCGE
m2.6.6_toxicology_written_summary.docx m2.6.6_toxicology_written_summary.docx Template SCGE
m2.6.6_toxicology_written_summary.docx m2.6.6_toxicology_written_summary.docx Template SCGE
m2.6.7_toxicology_tabulated_summary.docx m2.6.7_toxicology_tabulated_summary.docx Template SCGE
m2.6.7_toxicology_tabulated_summary.docx m2.6.7_toxicology_tabulated_summary.docx Template SCGE
m2.7.1_summary_biopharmaceutic_analytical.docx m2.7.1_summary_biopharmaceutic_analytical.docx Template SCGE
m2.7.1_summary_biopharmaceutic_analytical.docx m2.7.1_summary_biopharmaceutic_analytical.docx Template SCGE
m2.7.2_summary_clinical_pharm.docx m2.7.2_summary_clinical_pharm.docx Template SCGE
m2.7.2_summary_clinical_pharm.docx m2.7.2_summary_clinical_pharm.docx Template SCGE
m2.7.3_summary_clinical_efficacy.docx m2.7.3_summary_clinical_efficacy.docx Template SCGE
m2.7.3_summary_clinical_efficacy.docx m2.7.3_summary_clinical_efficacy.docx Template SCGE
m2.7.4_summary_ clinical_safety.docx m2.7.4_summary_ clinical_safety.docx Template SCGE
m2.7.4_summary_ clinical_safety.docx m2.7.4_summary_ clinical_safety.docx Template SCGE
m2.7.5_references.docx m2.7.5_references.docx Template SCGE
m2.7.5_references.docx m2.7.5_references.docx Template SCGE
Resource Name Description Type Source Date Issued Download
m3.2.a.1_facilities_equipment.docx m3.2.a.1_facilities_equipment.docx Template SCGE
m3.2.a.2_adventitious_agents.docx m3.2.a.2_adventitious_agents.docx Template SCGE
m3.2.a.3_novel_excipients.docx m3.2.a.3_novel_excipients.docx Template SCGE
m3.2.p.1_description_composition.docx m3.2.p.1_description_composition.docx Template SCGE
m3.2.p.2_pharmaceutical_development.docx m3.2.p.2_pharmaceutical_development.docx Template SCGE
m3.2.p.3_manufacture.docx m3.2.p.3_manufacture.docx Template SCGE
m3.2.p.4_control_excipients.docx m3.2.p.4_control_excipients.docx Template SCGE
m3.2.p.5_control_product.docx m3.2.p.5_control_product.docx Template SCGE
m3.2.p.6_reference_standards.docx m3.2.p.6_reference_standards.docx Template SCGE
m3.2.p.7_container_closure_system.docx m3.2.p.7_container_closure_system.docx Template SCGE
m3.2.p.8_stability.docx m3.2.p.8_stability.docx Template SCGE
m3.2.r_regional_information.docx m3.2.r_regional_information.docx Template SCGE
m3.2.s.1_general_information.docx m3.2.s.1_general_information.docx Template SCGE
m3.2.s.2_manufacture.docx m3.2.s.2_manufacture.docx Template SCGE
m3.2.s.3_characterization.docx m3.2.s.3_characterization.docx Template SCGE
m3.2.s.4_control_drug_substance.docx m3.2.s.4_control_drug_substance.docx Template SCGE
m3.2.s.5_reference_standards.docx m3.2.s.5_reference_standards.docx Template SCGE
m3.2.s.6_container_closure_system.docx m3.2.s.6_container_closure_system.docx Template SCGE
m3.2.s.7_stability.docx m3.2.s.7_stability.docx Template SCGE
m3.3_references.docx m3.3_references.docx Template SCGE
Resource Name Description Type Source Date Issued Download
m4.2.1_pharm_study_report_template.docx m4.2.1_pharm_study_report_template.docx Template SCGE
m4.2.2_PK_study_report_template.docx m4.2.2_PK_study_report_template.docx Template SCGE
m4.2.3_tox_study_report_template.docx m4.2.3_tox_study_report_template.docx Template SCGE
m4.3_references.docx m4.3_references.docx Template SCGE
Resource Name Description Type Source Date Issued Download
m5.2_tabulated_list_clinical_studies.docx m5.2_tabulated_list_clinical_studies.docx Template SCGE
m5.2_tabulated_list_clinical_studies.docx m5.2_tabulated_list_clinical_studies.docx Template SCGE
m5.4_references.docx m5.4_references.docx Template SCGE
m5.4_references.docx m5.4_references.docx Template SCGE
Resource Name Description Type Source Date Issued Download
Comprehensive Table of Contents Headings and Hierarchy (eCTD v4.0) eCTD v4.0 Comprehensive Table of Contents Headings and Hierarchy Guidance FDA 01-Feb-2025
eCTD Specifications for File Format Types Specifications for File Format Types Using eCTD Specifications Guidance FDA 01-Feb-2025
FDA Regional eCTD v4.0 Module 1 Implementation Guide FDA Module 1 Electronic Common Technical Document (eCTD) v4.0 Implementation Guide v1.7 Guidance FDA 01-Jun-2024
Guidance for Industry M4: The CTD — General Questions and Answers Guidance for Industry M4: The CTD — General Questions and Answers Guidance FDA 01-Dec-2004
ICH eCTD v4.0 Implementation Guide ICH eCTD v4.0 Implementation Guide Guidance External 21-May-2024
M4E: The CTD — Efficacy M4E(R2): The CTD — Efficacy Guidance FDA 01-Jul-2017
M4E: The CTD — Quality THE COMMON TECHNICAL DOCUMENT FOR THE REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE: QUALITY – M4Q(R1) Guidance External 12-Sep-2002
M4S: The CTD — Safety THE COMMON TECHNICAL DOCUMENT FOR THE REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE: SAFETY – M4S(R2) Guidance External 01-Dec-2002
M4: The CTD — Organization ORGANISATION OF THE COMMON TECHNICAL DOCUMENT FOR THE REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE Guidance External 15-Jun-2016
PDF Specifications Portable Document Format (PDF) Specifications Guidance FDA 01-Sep-2016
Technical Conformance Guide (eCTD v4.0) eCTD v4.0 Technical Conformance Guide Guidance FDA 01-Mar-2025