Step

Description

More information

1

Create one or more HTML files containing the text of the trial protocol. One file per protocol section is suggested.

2

Within each file, make code additions and changes required for processing by the MedML Installer utility.

Modifying the trial protocol HTML files

3

Create an XML file that defines the trial protocol in a DOCUMENTATION tag and as many DOCBODY tags as there are trial protocol HTML files. Use the BOOKMARKDOC DOCTYPE attribute.

• Creating a documentation definition XML file
• Examples of documentation definition XML files
• MedML online Help

4

Create a Table of Contents file that includes each heading or subsection to which you want users to be able to link.

Creating a Table of Contents file

5

Link each item in the Table of Contents file to the appropriate trial protocol HTML file.

Linking between document files

6

Associate the DOCUMENTATION definition with a study version.

Trial documentation and study versions

7

Process the trial documentation in the MedML Installer utility to load the files into the InForm database.

Utilities Guide