OECD Harmonised Templates: Frequently Asked Questions

 

Q1.  Is use of OECD templates mandatory in OECD countries?

A1.  OECD governments are encouraged to incorporate the harmonised templates into their national programmes; however, it is up to each government to choose the best approach for doing so.

Q2.  What is an “XML schema” and what is its relationship to templates?

A2.  Extensible Mark-up Language (XML) is a computer language that permits the easy electronic interchange of documents.   An XML “schema” describes the structure of a particular XML document.  OECD is currently developing a separate XML schema for each template (e.g., for the “hydrolysis template”, there will be a “hydrolysis XML schema”).   Database systems which incorporate these schema will be able to seamlessly exchange studies electronically.

Q3.  What is the relationship between the templates and data entry screens?

A3.  A data entry screen can be a visual representation of a template on a computer screen, but it should be linked to a database and allow for the manual entry and storage of information. OECD has not produced data entry screens for the templates. Member countries are invited to develop any data entry screen they wish, but they should be based on the template structure and be able to generate harmonised XML exchange files.

Q4.  Are these templates the same as the IUCLID database?

A4.  No.  IUCLID is an EU database system designed for data entry/management of information on chemicals. IUCLID is also the recommended system to gather information within the OECD High Production Volume (HPV) Chemicals Programme, and there is currently a joint OECD/EU project to further develop the IUCLID database system. As with other databases used in OECD member countries, the aim of the OECD project on templates is to facilitate the reporting of summary data in the same format so that such information in one system can be exchanged across other systems used by other programmes and governments.  For example, information collected via IUCLID based on the OECD templates and XML schema could be exchanged with other governments that use the same templates/schema (e.g., a US database which contains information on high production volume chemicals)

Q5.  Must all parts of a template be completed (regardless of the programme or government to which the information is submitted)?

A5.  The OECD templates are tools that can be used by different national/regional authorities or international programmes for reporting summaries of test results. It is up to each authority to decide for which fields within a template, reporting is necessary.

Q6.  Who fills out the templates?

A6.  It is up to the different regulatory programmes to decide who provides the information listed in the template (e.g. it could be provided by a company, a test house, a government or a combination of these).

Q7.  Are these templates to be used for full studies as well as for robust summaries of the studies?

A7.  The templates are only intended for reporting summary information of studies. They are not meant to replace the full study reports.

Q8.  Should only studies performed according to OECD Test Guidelines be summarised according to these templates?

A8.  It is up to each government to decide which studies should be summarised using these templates. For a given endpoint, the template should be able to accommodate any type of relevant test result, not only from studies performed according to the latest OECD test guidelines (e.g., studies found in the open literature).

Q9.  Are there any plans to translate the templates into languages other than English?

A9.  There are no plans at this time to translate the templates. Member countries are free to develop data entry screens with field labels and guidance in their national language. To ensure exchangeability of data entered using these screens, the XML file generated has to follow the XML schema adopted within the OECD project.