eSubmission

Overview

This section provides examples for preparing electronic submissions (eSubmissions) to regulatory agencies using pharmaverse packages. eSubmissions are a critical component of the drug approval process, requiring properly formatted and validated datasets along with comprehensive documentation.

The examples demonstrate how to leverage pharmaverse tools to ensure your submissions meet regulatory requirements and follow industry best practices.

Examples

In our eSubmission example, you will find ever-evolving guidance on creating and checking all of the key clinical reporting components of an eSubmission when using R and open source

Analysis Data Reviewer’s Guide

ADRG (Analysis Data Reviewer’s Guide) - Learn how to create an Analysis Data Reviewer’s Guide, a key document in regulatory submissions. The ADRG provides reviewers with essential information about the analysis datasets, data structures, and derivations used in the submission. This example demonstrates how to document dataset specifications, define.xml generation, and other critical components of a complete eSubmission package.

Key Components of eSubmissions

Successful electronic submissions typically include:

Datasets - Properly formatted SDTM and ADaM datasets in SAS transport (XPT) format
Define.xml - Machine-readable dataset and variable definitions
Reviewers Guides - Comprehensive guide to the tabulation and analysis datasets and derivations
Readable Code - Accessible and understandable TLG programs for key endpoints

Regulatory Standards

eSubmissions must comply with various regulatory standards and guidance:

CDISC Standards - SDTM, ADaM, Define-XML specifications
FDA Guidance - Study Data Technical Conformance Guide
ICH Guidelines - International standards for data standards and eCTD

Key Packages Used

{xportr} - Creating SAS transport files and performing eSub checks
{metacore} - Managing metadata and specifications
{metatools} - Working with metadata and specifications to format and check data
Various pharmaverse packages - Dataset creation and validation

Getting Started

The examples demonstrate:

Preparing analysis datasets for submission
Generating required documentation
Validating datasets against specifications
Creating submission-ready packages

Following these examples will help ensure your submissions meet regulatory requirements and facilitate efficient review by regulatory agencies.

Resources

For more information on eSubmissions and regulatory requirements, consult: - CDISC website - FDA Study Data Standards Resources

--- title: "eSubmission" --- ## Overview This section provides examples for preparing electronic submissions (eSubmissions) to regulatory agencies using pharmaverse packages. eSubmissions are a critical component of the drug approval process, requiring properly formatted and validated datasets along with comprehensive documentation. The examples demonstrate how to leverage pharmaverse tools to ensure your submissions meet regulatory requirements and follow industry best practices. ## Examples In our [eSubmission example](esub.qmd), you will find ever-evolving guidance on creating and checking all of the key clinical reporting components of an eSubmission when using R and open source ### Analysis Data Reviewer's Guide - **[ADRG (Analysis Data Reviewer's Guide)](esub.qmd)** - Learn how to create an Analysis Data Reviewer's Guide, a key document in regulatory submissions. The ADRG provides reviewers with essential information about the analysis datasets, data structures, and derivations used in the submission. This example demonstrates how to document dataset specifications, define.xml generation, and other critical components of a complete eSubmission package. ## Key Components of eSubmissions Successful electronic submissions typically include: - **Datasets** - Properly formatted SDTM and ADaM datasets in SAS transport (XPT) format - **Define.xml** - Machine-readable dataset and variable definitions - **Reviewers Guides** - Comprehensive guide to the tabulation and analysis datasets and derivations - **Readable Code** - Accessible and understandable TLG programs for key endpoints ## Regulatory Standards eSubmissions must comply with various regulatory standards and guidance: - **CDISC Standards** - SDTM, ADaM, Define-XML specifications - **FDA Guidance** - Study Data Technical Conformance Guide - **ICH Guidelines** - International standards for data standards and eCTD ## Key Packages Used - **`{xportr}`** - Creating SAS transport files and performing eSub checks - **`{metacore}`** - Managing metadata and specifications - **`{metatools}`** - Working with metadata and specifications to format and check data - **Various pharmaverse packages** - Dataset creation and validation ## Getting Started The examples demonstrate: - Preparing analysis datasets for submission - Generating required documentation - Validating datasets against specifications - Creating submission-ready packages Following these examples will help ensure your submissions meet regulatory requirements and facilitate efficient review by regulatory agencies. ## Resources For more information on eSubmissions and regulatory requirements, consult: - [CDISC website](https://www.cdisc.org/) - [FDA Study Data Standards Resources](https://www.fda.gov/industry/fda-data-standards-advisory-board/study-data-standards-resources)