Graphic of several documents with the following:
The eCTD Backbone File Specification for Study Tagging Files - A Study Tagging File (STF) should be provided with the submission of any file or group of files belonging to a study in Modules 4 and 5. STFs are required by the United States, are not required in Europe, and are not allowed in Japan. The STF provides for additional heading elements and heading attributes not currently provided by the eCTD Document Type Definition (DTD). In the STF, heading elements are called file-tags and are included in the doc-content element. Heading attributes are included in the study-identifier element. The eCTD Backbone File Specification for Study Tagging Files 2.6.1 (PDF - 149KB) (6/3/2008)
Study Data Specifications - These specifications are for submitting animal and human study datasets in electronic format. Datasets are views of the study data used by reviewers to conduct specific analyses of the study data. They may include both raw and derived data. Because of the unpredictability of the scientific review process, it is impossible to enumerate a prior list of all datasets needed for review. Prior to the submission, sponsors should discuss with the review division the datasets that should be provided, the data elements that should be included in each dataset, and the organization of the data within the file. Additionally, not all FDA Centers have adopted all aspects of these specifications; sponsors are advised to discuss their data needs with the reviewing division prior to preparing data for submission. Study Data Specifications (PDF - 199KB) (updated 6/27/2011)
eCTD Validation Specifications - Validation is an important processing component in order to ensure compliance with the eCTD specification and improve the availability and reviewability of individual submissions and applications throughout their lifecycle. Review the FDA's current validation specifications.In addition to the validation criteria specified in the current validation specifications document, FDA may perform additional validation checks for both eCTD and non-eCTD submissions. These validation checks are intended to ensure that submissions are processed and routed accurately and in a timely fashion. The additional validation checks include:Ensuring that the application form submitted matches the application type specified in the us_regional.xml file, e.g., the us-regional.xml specified application type is NDA but the sponsor has submitted a 1571. Ensuring the consistency of the application number specified in the usâ€'regional.xml file and application form.eCTD Validation Specifications (12/10/2010)
Portable Document Format Specifications - These specifications are for submitting documents in portable document format (PDF). The purpose of this document is to provide specifications for submitting PDF files that align with the ICH M2 recommendations and that are in a format that the receiving Center currently supports. Portable Document Format Specifications (PDF - 37KB) (updated 1/20/2012)
Transmission Specifications - This document provides information on transmitting electronic submissions using eCTD specifications. Details are included for transmitting the electronic submission on physical media or electronically. Transmission Specifications (PDF - 42KB) (updated 12/2011)')"