SGML is a metalanguage, which is a means of formally describing a language. More specifically, SGML is a markup language. It has been long been used in the publishing industry to associate document format with text. A basic design goal of SGML was to ensure that documents encoded according to its provisions should be transportable from one hardware and software environment to another without loss of information. The structure of SGML is based on a grouping of sections and elements that are annotated by start and end tags.
Tags are user-friendly phrases used to indicate the data elements contained within the tags.
DTDs are document-specific specifications for the structure of an SGML document. The ICH ICSR DTD defines the specific data elements to be included for electronic submission of adverse event data, the order of the elements, and their interrelationship. The most difficult and critical aspect of preparing the files for electronic transmission is mapping your database to the E2B data set and developing the extract programs to build the conformant SGML file. The level of difficulty in performing these steps is dependent upon how close your current database resembles the E2B data set. If the files do not successfully load into AERS you will be notified.