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Generating a valid ICH safety message
There are two levels of conformance in the XML specifications: a well-formed and a valid message.
A well-formed message is an XML document that conforms to the structural rules of XML:
- The first line should be the XML document declaration
- The document should contain at least one element (or tag)
- Every starting tag should have a closing tag
- Self-closing tags (for example, '<tag/>') are permitted when XML elements do not contain data
- Tags cannot overlap.
In addition, as XML is case sensitive, all the fields and attribute names have to be in lower case in order to comply with the XML DTD.
A Valid XML file is one, which has a DTD reference and which conforms to the ICH ICSR DTD and the TGA ICSR business rules.
The ICH ICSR DTD defines the valid elements (tags), attributes that may appear in a particular type of XML document and also defines element nesting rules.
The following XML special characters (excluding quotation marks) ">", "<" and "&" when occurring in text should always be replaced by ">" "<" and "&" respectively. Regarding all aspects of XML, the W3C standards should be followed.