13  Overview

The electronic Common Technical Document (eCTD) is a standard format for the electronic submission of applications, amendments, supplements, and reports from the applicant to the regulator. The eCTD offers a solution to submit documents stored in a standard directory structure, with file integrity validation mechanisms in place.

To submit TLFs created by R to regulatory agencies, we should follow the spirit of the existing eCTD submission guidelines to prepare the deliverables, and provide the essential details in the relevant documents for review.

The goal of the following two chapters is to provide guidance to follow Section of the FDA Study Data Technical Conformance Guide:

Sponsors should provide the software programs used to create all ADaM datasets and generate tables and figures associated with primary and secondary efficacy analyses. Furthermore, sponsors should submit software programs used to generate additional information included in Section 14 CLINICAL STUDIES of the Prescribing Information (PI)26 if applicable. The specific software utilized should be specified in the ADRG. The main purpose of requesting the submission of these programs is to understand the process by which the variables for the respective analyses were created and to confirm the analysis algorithms. Sponsors should submit software programs in ASCII text format; however, executable file extensions should not be used.

Chapter 14 will focus on preparing proprietary R packages and analysis code into proper formats for submission.

Chapter 15 will discuss the recommendations to make the R code running environment reproducible for dry run tests and reviews.