TEMPLATE READABLE FORMAT

The specifications of the OECD Harmonised Templates (OHTs) are made available as Word documents in order to provide the user with a readable version (the developers’ specifications being made available as XML schema definition documents). This also facilitates the review and commenting process by experts when preparing future updates of the templates.

TEMPLATE TITLE

The OHTs’ specifications are identified with a title shown at the top of each OHT Word document, providing the following information: <OHT number> - <OHT name>_<version number> -<version date>

TEMPLATE STRUCTURE

Compared to the initial structure of the templates, the new version published in 2016 was simplified. Each OHT is now presented in six columns:

Column 1: Line no:
Each element of template definition is presented in a row. For facilitating the review of the document, each row is identified by a line number.

Column 2: Field name:
Contains the label of the field, section heading or table title, in the user interface developed by software provider.

Column 3: Field type / Display type:

• Field type: Shows the type of the element added to the user interface. Possible content can be, for example, confidentiality flag, header level, picklist with remarks, check box, text field.
• Display type: Two display levels are defined for the OHTs: ‘Basic’, and ‘Detailed’. This is used to differentiate fields that are relevant to study summaries in the first case, and to robust study summaries in the latter case.

Column 4: Picklist / Freetext template:
Contains, where relevant, the content of the agreed picklists (list of values proposed to user’s choice) and/or free text templates which are suggested for completion by the user in order to to facilitate the comprehensive description of the element considered.

Column 5: Help text:
Contains the guidance for the user to help the understanding of the purpose of the field, and give recommendations on how to fill-in relevant information.

Column 6: Remarks / Guidance / Cross-reference:
Contains different types of information, such as:

• Guidance for field condition: This proposes to software provider to implement some field conditions in order to facilitate data entry.
• Cross-reference: When a field contains a link to another piece of information (e.g. another document), the type of information is specified.
• Guidance for data migration: This proposes to software provider to implement field content migration from the previous version of the OHT.

Also contains any other remarks related to the element considered.