Format and conventions used for OECD Harmonised Templates

 

An OECD Harmonised Template provides predefined fields, picklist values and freetext prompts related to a given endpoint that are considered necessary to summarise a study. In this context, an endpoint is an information requirement or data point with regard to the physico-chemical properties of the substance, environmental fate and behaviour, ecotoxicological information, toxicological information and specific information (e.g. residues in food and feedingstuffs) according to a given chemical programme.

Each template is structured into five main parts, which feature a number of data entry fields that are common to (almost) all templates and are therefore called "generic" elements. These include:

  • All fields of part ADMINISTRATIVE DATA, i.e. Record ID, Submission substance ID, Record identifier, Modification history (Date, Author, Remarks), Flags (Confidentiality flag, Justification for confidentiality, Regulatory purpose), Purpose flag, Robust study summary, Used for classification, Used for MSDS, Data waiving, Justification for data waiving, Study result type, Study period, Reliability, Rationale for reliability incl. deficiencies (Note that the latter two fields have been moved to this part from the previous part APPLICANT'S SUMMARY AND CONCLUSION.)
  • All fields of part DATA SOURCE,i.e. Reference (Reference type, Author(s) (or transferred reference), Year, Title, Bibliographic source, Testing laboratory, Report no., Owner company, Company study no., Report date), Data access, Data protection claimed, Cross-reference to same study
  • The following fields of part MATERIALS AND METHODS: Test guideline (Qualifier, Guideline, Deviations from guideline), Principles of method if other than guideline, GLP compliance, Test material equivalent to submission substance identity, Test material identity (Identifier, Identity), Details on test material, Confidential details on test material, Any other information on materials and methods incl. tables
  • The following field of part RESULTS AND DISCUSSION: Any other information on results incl. tables
  • All fields of part OVERALL REMARKS, ATTACHMENTS,i.e. Overall remarks, Attached background material (Attached document, Remarks), Attached full study report
  • The following field of part APPLICANT'S SUMMARY AND CONCLUSION: Conclusions, Executive summary, Cross-reference to other study

Note

The generic field "Guideline" is not a generic field in a strict sense, since endpoint-specific picklists are provided.

As an exception to the rule, the generic part MATERIALS AND METHODS is not provided in the template no. 88 Effectiveness against target organisms and intended uses - general information.

In addition to generic fields, endpoint-specific data entry fields are available, the number of which varying from none or only a few up to many, depending on the degree of structure required for a given endpoint. For example, template no. 40. Additional information on environmental fate and behaviour provides only generic fields as no specific fields are needed here. On the other hand, many specific fields are provided in template no. 41. Short-term toxicity to fish.

In the first version of OECD Harmonised Templates, all generic data entry fields were compiled in a separate template which was referred to in the endpoint-specific templates. In the updated templates presented with this document, all generic fields are integrated except for fields subsumed under ADMINISTRATIVE DATA, which are described only once and referenced from each template by means of hyperlinks.

Note
The template "Annotations" is presented as a separate document. It replaces the former part EVALUATION, SUMMARY AND CONCLUSION BY REGULATORY AUTHORITY in the generic fields template of the first version.

It should be noted that, for technical reasons, the naming conventions used for the XML schema of the fields subsumed under ADMINISTRATIVE DATA or ANNOTATIONS are somewhat different from those used for all other fields. 

The format and conventions used for the updated OECD Harmonised Templates is described in the following subchapters, which can be seen as seven columns constituting each template.

 

Column 1: Field number

Column 2: Field Description [Field Label] Column 2: Field Description [Field Label]

Column 3: Field Type, Data Type, Group ID, Mac. occ., Detail Level, Picklist Code

Column 4: Picklist / Freetext Template / Remarks Column 4: Picklist / Freetext Template / Remarks

Column 5: Help Text

Column 6: Explanation for use in Data Element Dictionary (DED)

Column 7: XML Schema