---
title: "Resources - Regulatory templates"
slug: "resources-regulatory-templates"
status: "update"
updated: 2026-07-20T23:30:23Z
published: 2026-09-09T19:57:39Z
canonical: "bgtcplaybook.document360.io/resources-regulatory-templates"
---

> ## 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.

# Resources - Regulatory templates

## INTERACT Meeting

[](https://cdn.document360.io/a7cea773-7486-41ac-bd50-afa0255ce01f/Images/Documentation/INTERACT MEETING REQUEST_MEETING INFORMATION PACKAGE_Template.docx)INTERACT MEETING REQUEST_MEETING INFORMATION PACKAGE_Template77.33 KB[](https://cdn.document360.io/a7cea773-7486-41ac-bd50-afa0255ce01f/Images/Documentation/INTERACT MEETING REQUEST_MEETING INFORMATION PACKAGE_Template.docx)

## Pre-IND Meeting

[](https://cdn.document360.io/a7cea773-7486-41ac-bd50-afa0255ce01f/Images/Documentation/PRE_IND MEETING REQUEST_template.docx)PRE_IND MEETING REQUEST_template78.73 KB[](https://cdn.document360.io/a7cea773-7486-41ac-bd50-afa0255ce01f/Images/Documentation/PRE_IND MEETING REQUEST_template.docx)[](https://cdn.document360.io/a7cea773-7486-41ac-bd50-afa0255ce01f/Images/Documentation/PRE_IND MEETING INFORMATION PACKAGE Template.docx)PRE_IND MEETING INFORMATION PACKAGE Template79.10 KB[](https://cdn.document360.io/a7cea773-7486-41ac-bd50-afa0255ce01f/Images/Documentation/PRE_IND MEETING INFORMATION PACKAGE Template.docx)

## IND Submission

#### **Module 1: Admin Information**

[](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)

#### **Module 2.6: Non-Clinical Written and Tabulated Summaries**

[](https://cdn.document360.io/a7cea773-7486-41ac-bd50-afa0255ce01f/Images/Documentation/NON-CLINICAL OVERVIEW_Template.docx)NON-CLINICAL OVERVIEW_Template30.60 KB[](https://cdn.document360.io/a7cea773-7486-41ac-bd50-afa0255ce01f/Images/Documentation/NON-CLINICAL OVERVIEW_Template.docx)[](https://cdn.document360.io/a7cea773-7486-41ac-bd50-afa0255ce01f/Images/Documentation/NON-CLINICAL WRITTEN AND TABULATED SUMMARIES_template.docx)NON-CLINICAL WRITTEN AND TABULATED SUMMARIES_template46.89 KB[](https://cdn.document360.io/a7cea773-7486-41ac-bd50-afa0255ce01f/Images/Documentation/NON-CLINICAL WRITTEN AND TABULATED SUMMARIES_template.docx)[](https://cdn.document360.io/a7cea773-7486-41ac-bd50-afa0255ce01f/Images/Documentation/BGTC Pharmacy Manual Template(1).docx)BGTC Pharmacy Manual Template44.27 KB[](https://cdn.document360.io/a7cea773-7486-41ac-bd50-afa0255ce01f/Images/Documentation/BGTC Pharmacy Manual Template(1).docx)

#### Module 3.3: Literature

[](https://cdn.document360.io/a7cea773-7486-41ac-bd50-afa0255ce01f/Images/Documentation/BGTC%20Pharmacy%20Manual%20Template.docx)BGTC Pharmacy Manual Template44.27 KB[](https://cdn.document360.io/a7cea773-7486-41ac-bd50-afa0255ce01f/Images/Documentation/BGTC%20Pharmacy%20Manual%20Template.docx)

#### **Module 4: Non-clinical data**

[](https://cdn.document360.io/a7cea773-7486-41ac-bd50-afa0255ce01f/Images/Documentation/Module4_Template.docx)Module4_Template32.26 KB[](https://cdn.document360.io/a7cea773-7486-41ac-bd50-afa0255ce01f/Images/Documentation/Module4_Template.docx)

#### **Module 5: Clinical study reports**

[](https://cdn.document360.io/a7cea773-7486-41ac-bd50-afa0255ce01f/Images/Documentation/Module 5_ INFORMED CONSENT_Template.docx)Module 5_ INFORMED CONSENT_Template124.35 KB[](https://cdn.document360.io/a7cea773-7486-41ac-bd50-afa0255ce01f/Images/Documentation/Module 5_ INFORMED CONSENT_Template.docx)[](https://cdn.document360.io/a7cea773-7486-41ac-bd50-afa0255ce01f/Images/Documentation/Module 5_ CLINICAL PROTOCOL_Template.docx)Module 5_ CLINICAL PROTOCOL_Template380.76 KB[](https://cdn.document360.io/a7cea773-7486-41ac-bd50-afa0255ce01f/Images/Documentation/Module 5_ CLINICAL PROTOCOL_Template.docx)