Introduction to OECD Harmonised Templates

 

The OECD Harmonised Templates are standard data formats for reporting studies done on chemicals to determine their properties or effects on human health and the environment (e.g. hydrolysis, skin irritation, repeated dose toxicity, etc.). They are no data entry screens, but guides for structuring data entry/database management systems so they are developed. All of the data elements are listed which could be relevant for a summary of a study as well as the format in which the information should be entered and stored electronically, together with field-specific help texts intended to guide end users. Harmonisation in this context means that these templates can be used as models for reporting studies and other information on any type of a chemical (e.g. pesticides, biocides, industrial chemicals).

As the templates are intended to serve as standard formats for summarising data contained in any study report or publication related to particular endpoints, including studies that were not conducted according to current guidelines, they are designed in a very flexible way. This includes:

  • structured elements (i.e. fields, picklist items, freetext prompts, predefined tables) some of which may not be relevant for specific study summaries;
  • picklists for specific test guidelines which contain the most often cited guidelines, some of which may not be relevant for a specific regulatory programme;
  • guidance notes (i.e. help texts) which explain what kind of data entry is expected in a given field, but do not necessarily indicate whether the corresponding data are requested by any test guideline. However, most templates are nevertheless obviously biased towards studies performed according to the OECD Test Guidelines, as these are the internationally agreed standard.

The degree of complexity used in these templates follows the needs of the key study / robust study summary approach. The fields provided should be considered as a maximum degree of detail. It is generally accepted that much less details are needed in case of non-robust study summaries. This is reflected by the system of detail level introduced in the OECD templates. The detail level is an indicator showing whether a field is considered as basic information (Level 1) or basic plus additional information (Level 2).

By using these templates, governments and industry will easily be able to electronically exchange test study summary information. In order for information technology developers to build data entry screens and/or database systems based on the OECD Harmonised Templates, each template has to have a corresponding "XML schema". An XML (Extensible Mark-up Language) schema, or export format, is a common computer language which facilitates the electronic exchange of data across different computer systems for data entry, storage and management.

IUCLID 5, the International Uniform ChemicaL Information Database developed by the European Commission, is the first system that implemented completely the OECD Harmonised Templates. Information compiled in IUCLID 5 can be exchanged with other databases that use the same templates//XML schemas, even if the underlying computer systems are incompatible. In the revised OECD Harmonised Templates provided with this document (see overview table) some inconsistencies in IT-related field definitions have been fixed and all corrections made since the first publication of the templates have been integrated. The principle format has been kept, although some modifications proved necessary, in particular concerning the IT-related field specifications. The revised templates are in the HTML format, which makes all information easier to read as compared to the previously used Excel format. For instance cut off text as common in Excel cells is avoided and any predefined tables and executive summaries can be accessed through links. In this respect, the revised version features the full set of scientific and technical descriptions of the OECD Harmonised Templates.

 

Important

These OECD Harmonised Templates should not be seen as constituting OECD data requirements. Only those fields that are deemed relevant by a regulatory authority would be completed in that jurisdiction (i.e., all of the fields may not be completed in all countries). As to the level of detail required the relevant guidance documents for the respective chemical programme should be consulted.

The OECD Templates are also not prescriptive as to the order of appearance of any data entry fields or how the fields are technically implemented as long as this does not affect the harmonised and agreed upon data exchange format.