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NOTES to Sponsor-Investigators

By Tiffany Russell,2014-04-09 18:14
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NOTES to Sponsor-Investigators

Confidential IND Application - [Date] [Sponsor-Investigator Name]

NOTES to Sponsor-Investigators:

    - This template presents the sections that comprise the IND application. Guidance was

    derived from FDA IND regulations, FDA guidance documents and ICH Good Clinical

    Practice guidelines. Some of the wording in this template is taken directly from these

    reference documents.

    - For the purposes of this document, the term “drug” refers to both single drugs or biologics

    and combination drugs/biologics that fall under the proposed IND application.

    - It is required that each part of the IND be submitted in English.

    - Model text for use in the application is in black text.

    - Instructions and guidance are in [brackets] or italics.

    - Delete instructions and guidance from the submitted application.

    Investigational New Drug Application

Regulatory Sponsor: Provide name of Sponsor-Investigator, department

    name, address, and phone number during working

    hours

    Funding Sponsor: Provide name of primary funding institution, address,

    and phone number during working hours

    Study Product: Provide study drug name - generic, followed by trade

    name(s), if applicable

    Protocol Number: Provide DF/HCC protocol number if available

    Date: Provide date submitted to FDA

Confidential IND Application - [Date] [Sponsor-Investigator Name]

Section 1. FORM FDA 1571

Instructions and Guidance:

    - The current version of this form may be downloaded from the FDA web site at:

    http://www.fda.gov/opacom/morechoices/fdaforms/cder.html

    - The Sponsor-Investigator signs the Form 1571.

    - The completed Form 1571 is submitted as Section 1.

Confidential IND Application - [Date] [Sponsor-Investigator Name]

Section 2. TABLE OF CONTENTS

Instructions and Guidance:

    - Volume numbers should be included in the table of contents if multiple volumes are used.

    - Each major section should also have a table of contents.

    - Sponsor-Investigators may provide information regarding the introductory statement and

    investigational plan in a written cover letter.

    - Add sub-sections to the table of contents as appropriate.

    - A cross-reference letter or package insert may be submitted in lieu of required

    information for sections: 3 (Introductory Statement and General Investigational Plan), 4

    (Investigator’s Brochure), 6 (Chemistry, Manufacturing, and Control Data), 7

    (Pharmacology and Toxicology Data), and 8 (Previous Human Experience).

    - Remember to delete all instructions and guidance from the submitted application.

Section Page

1. FORM FDA 1571 2

2. TABLE OF CONTENTS 3

    3. INTRODUCTORY STATEMENT AND GENERAL INVESTIGATIONAL

    PLAN

    3.1

4. INVESTIGATOR’S BROCHURE (IB)

    4.1

5. PROTOCOL

    5.1 Study Protocol

    5.2 Investigator and Facilities Information

    5.3 Institutional Review Board Information

6. CHEMISTRY, MANUFACTURING, AND CONTROL DATA

    6.1 Environmental Exemption Claim

    6.2

7. PHARMACOLOGY AND TOXICOLOGY DATA

    7.1

8. PREVIOUS HUMAN EXPERIENCE

    8.1

9. ADDITIONAL INFORMATION

    9.1 DF/HCC Institutional Data and Safety Monitoring Plan

    9.2

Confidential IND Application - [Date] [Sponsor-Investigator Name]

SECTION 3. INTRODUCTORY STATEMENT AND GENERAL

    INVESTIGATIONAL PLAN

Instructions and Guidance:

    - The information in this section should place the developmental plan for the investigational

    agent into perspective and allow FDA to anticipate your needs.

    - This section should average 2-3 pages.

    - Sponsor-Investigators may provide information regarding the introductory statement and

    investigational plan in the cover letter.

    - Remember to delete all instructions and guidance from the submitted application.

Introductory Statement

    Provide a brief summary of the objectives of the research plan(s) submitted in this IND application. This should include a brief discussion of the disease state to be assessed.

[For studies referencing another IND and/or marketed products:]

    Provide a brief statement that includes the name of the drug, and the name and address of the manufacturer. The statement should contain a reference to the package insert or Letter of Authorization to cross-reference another IND in order to address the requirements to identify the drug, its active ingredients, structural formula and formulation.

Note: Append the package insert in section 4 (Investigator’s Brochure) if applicable. Append the

    Letter of Authorization to cross-reference in section 9 (Additional Information).

    Include a brief summary of the route of administration and planned exposure (e.g., duration of study drug administration).

[For studies not using a cross-reference:]

    Provide a brief introductory statement including the drug name, all active ingredients), pharmacological class, structural formula (if known), formulation and dose, route of administration, and planned exposure (e.g., duration of study drug administration).

    Provide a high level summary of preclinical data to date including mechanism of action, efficacy and safety. Content should be a brief synopsis of section 7 (Pharmacology and Toxicology Data).

    Provide a high level summary of prior human experience with the investigational drug. Content should be a brief synopsis of section 8 (Previous Human Experience). Include a statement about whether the drug has been withdrawn from investigation or marketing in any country for reason related to safety or efficacy. Cite the reason for the withdrawal.

General Investigational Plan

    Discuss the rationale for the use of the drug and the specific study (ies).

    Include the indication(s) to be studied, overall objectives, study design, estimated enrollment in the trial, treatment plan, and anticipated risks based on preclinical and clinical experiences with the drug.

Note: Indicate whether research plans are developed for the entire year.

3.1

Confidential IND Application - [Date] [Sponsor-Investigator Name]

SECTION 4. INVESTIGATOR’S BROCHURE (IB)

Instructions and Guidance:

    - Sponsor-Investigators are not required to submit an Investigator’s Brochure for a single

    center study. An Investigator’s Brochure is required for multi-center studies.

    - A cross-reference letter or package insert may be submitted in lieu of required information

    for the Investigator’s Brochure.

    - The package insert may be found in the Physician’s Desk Reference, the FDA website, or

    the United States Pharmacopoeia National Formulary.

    - Remember to delete all instructions and guidance from the submitted application.

[For studies limited to DF/HCC:]

    Include a statement that the IND meets the requirements for a Sponsor-Investigator single center study, and that under the provisions of 21 CFR 312.55, an Investigator’s Brochure is not required.

[For multi-center studies referencing another IND and/or marketed products:]

    Provide a brief statement that references the package insert or Letter of Authorization to cross-reference another IND in order to address the requirements of an Investigator’s Brochure.

    Notes: Append a copy of the package insert behind this page. Append the Letter of Authorization to cross-reference in section 9 (Additional Information).

[For multi-center studies not using a cross-reference:]

    Provide an Investigator’s Brochure. The outline below embodies the elements of an Investigator’s Brochure according to Good Clinical Practice. For detailed guidance related to content of the sub-sections, refer to the ICH Guidance for Good Clinical Practice. (See http://www.ich.org -

    Efficacy Guidelines E6.)

4.1 Title Page

4.2 Table of Contents

4.3 Summary

4.4 Introduction

4.5 Physical, Chemical, and Pharmaceutical Properties and Formulation

4.6 Nonclinical Studies

    4.6.1 NonClinical Pharmacology

    4.6.2 Pharmacokinetics and Product Metabolism in Animals

    4.6.3 Toxicology

4.7 Effects in Humans

Confidential IND Application - [Date] [Sponsor-Investigator Name]

    4.7.1 Pharmacokinetics and Product Metabolism in Humans

    4.7.2 Safety and efficacy

    4.7.3 Marketing Experience

4.8 Summary of Data and Guidance for the Investigator

4.9 References

Confidential IND Application - [Date] [Sponsor-Investigator Name]

SECTION 5. PROTOCOL

Instructions and Guidance:

    - A separate title page should be included for each section.

    - Delete any sub-section if not applicable.

    - The study protocol should use the standard DF/HCC protocol format (see below).

    - Remember to delete all instructions and guidance from the submitted application.

Section Page

5.1 Study Protocol

    5.1.1 Consent Form

5.2 Investigator and Facilities Information

    5.2.1 Principal Investigator

    5.2.2 Form FDA 1572

    5.2.3 Principal Investigator Curriculum Vitae

    5.2.4 Co-investigator Credentials

    5.2.5 Form FDA 3454

    5.2.6 Form FDA 3455 (if applicable)

    5.2.7 Conflict of Interest Documentation (if applicable)

5.3 Institutional Review Board Information

Confidential IND Application - [Date] [Sponsor-Investigator Name]

Instructions and Guidance:

    - List all protocols by title on this face sheet in the order they are attached.

    - Include copies of all protocols to be conducted under this IND application.

    - Remember to delete all instructions and guidance from the submitted application.

5.1 Study Protocol Insert Protocol(s)on next page.

    Confidential IND Application - [Date] [Sponsor-Investigator Name]

    Instructions and Guidance:

    - Insert the study protocol(s) at this point.

    - Phase 1 studies should provide an outline of the investigation including a statement of the objectives and purpose of the investigation, an estimate of subjects to be studied, a description of safety exclusions, a description of dosing plan (duration, dose, method used to determine dose), measures to ensure and evaluate subject safety (e.g., performance of blood chemistries, and toxicity-based stopping or dose adjustment rules). - Phase 2 and 3 protocols should include alternative plans to address anticipated deviations (i.e. early crossover of non-responders to alternative therapy).

    - Do not include the DF/HCC Institutional Data and Safety Monitoring Plan (DF/HCC DSMP) in this section. A full version of the DF/HCC DSMP will appear in section 9 of this IND application.

    - Suggested content of the protocol as described by DF/HCC format is listed below. - Remember to delete all instructions and guidance from the submitted application.

INDEX

     SCHEMA

    1.0 Objectives

    2.0 Background

    3.0 Participant Selection

    4.0 Registration Procedures

    5.0 Treatment Plan

    6.0 Expected Toxicities and Dosing Delay/Dose Modifications

    7.0 Drug Formulation and Administration

    8.0 Correlative Studies

    9.0 Study Calendar

    10.0 Measurement of Effect

    11.0 Adverse Event Reporting Requirements

    12.0 Data and Safety Monitoring

    13.0 Regulatory Consideration

    14.0 Statistical Consideration

    15.0 Publication Plan

    16.0 References

    17.0 Appendices

Confidential IND Application - [Date] [Sponsor-Investigator Name]

Instructions and Guidance:

    - List protocol title(s) for which consent forms are attached. List in the order they are

    attached.

    - Include copies of all consent forms for protocols noted in the protocol section.

    - For gene therapy studies, the gene therapy component of the treatment and any

    associated risks to the subject should be clearly identified in the consent form.

    - Remember to delete all instructions and guidance from the submitted application.

     5.1.1 Consent Form: Insert Protocol Consent Form(s) on next page.

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