Electronic common technical document

Abstract: The Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) is a standard for submitting data tabulations to the FDA in support of marketing applications. In July 2004, this standard became part of the FDA Study Data Specification referenced in the electronic Common Technical Document (eCTD) Guidance. This article will provide an overview of evolution and status of the SDTM and the associated Implementation Guides, commonly referred to as the Study Data Tabulation Model Implementation Guide for Human Clinical Trials (SDTMIG) and the Standard for Exchange of Nonclinical Data (SEND).

Abstract: The International Conference on Harmonisation’s electronic Common Technical Document (eCTD) endeavors to significantly change the pharmaceutical submission process. After decades of using paper, th...

Abstract: The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Common Technical Document (CTD) format has now become the obligatory format for the EU, Japan, Canada, Switzerland and Australia, and the recommended format in the US. Derivatives of the CTD are becoming widely adopted in other regions, including the ASEAN countries. An electronic CTD (eCTD) was developed in parallel with the CTD and the three ICH regions now accept eCTD filings. The purpose of this article is to survey the eCTD technical requirements, the implementation by different countries and to discuss some of the practicalities involved in writing, compiling and publishing eCTD applications. The eCTD has advantages over the CTD in terms of ease of use, archiving and for life-cycle management of registration information. The eCTD specification defines the folder structure, contents, XML backbone and the Study Tagging File for clinical and nonclinical studies. The design of the eCTD documentation needs to include considerations of document granularity, templates, shell documents and regional differences in filings; for example, the need for an Integrated Summary of Efficacy and Integrated Summary of Safety in the US. Regulatory agencies are moving to accept online filings, but these are currently commonly made using physical media such as CD, DVD or tape. The eCTD file needs to be ‘reviewer friendly’ by use of bookmarks, hyperlinking and tables of contents in individual documents. Prescriber and patient information can now be supplied electronically using the XML-based EU PIM Data Exchange Standard and the Structured Product Labelling in the US. Many commercial software tools are available for content management, assembly, compilation, publishing, labelling, electronic validation and review. eCTDs can be developed using leased or purchased software, specialist contract services, outsourcing from software vendors or using contract research organisations.

Abstract: The electronic Common Technical Document (eCTD) is defined as an interface for industry to agency transfer of regulatory information, while at the same time taking into consideration the facilitation of the creation, review, lifecycle management and archival of the electronic submission. eCTD is just an ‘envelope’ that will enable industry to communicate and exchange information easily and should be considered only as the final step in the process of generating an electronic submission. The authors firmly believe that optimal eCTD is based on a solid integrated document management system.Submission management in the generics industry is a process and the document management system should therefore be adapted to support this process of dossier creation and post-application management of hundreds, or even thousands, of dossiers. In order to effectively implement this process, it is highly recommended that a document management system is configured in such away that every individual document is stored in the...