The Annotations tab provides a means for making annotations on any record in the Substance dataset, namely the record for sections 0 to 3, any single Endpoint study record or any single Endpoint summary record in sections 4 to 13. The annotations feature is primarily designed for the use by regulatory authorities, e.g. the European Chemicals Agency or Competent Authorities of the Member States, when evaluating the data submitted by the registrant. However, it may also be used by the legal entity compiling a Substance dataset, for example, in the context of the internal review process.

A major advantage of using the annotations feature is that the regulatory authorities can specify the outcome of their evaluation directly related to the respective study or endpoint summary submitted. Or they can adopt the annotated submitter's version in any evaluation document, e.g. the technical dossier supporting a REACH-related Annex XV Dossier to be produced by the Agency and CAs. This so-called all-in-one approach aims at minimising the duplication work, as the regulatory authorities can adopt the records submitted and need to comment only on discrepancies and deficiencies.

Technically, annotation records are kept outside of a Substance dataset, but are directly linked to the record addressed. This means, that any annotations record has its own UUID and can be filtered out from any export, import, create Dossier or print process.

Annotation records can support the internal review and revision process particularly when several persons are involved in the preparation of a Substance dataset. Instead of making any changes in the Endpoint records, which will not be possible when a record is write-protected, comments are included in annotation records related to the Endpoint records. Any annotation record has its own UUID, which is associated to one specific Endpoint record which in turn has also a UUID. It is therefore possible to export and import only annotation records. They will be linked to the corresponding Endpoint records, provided that they contain the correct UUIDs. This means that any commenter must be provided with the Endpoint records from the master dataset.

The following screenshot shows an example of an annotation record for an endpoint study summary.

An annotation record consists of the following three tabs:

In the following, the fields provided in tab Data are described.

Name of authority / organisation

This field is for identifying the regulatory authority or organisation evaluating or making comments on a submitter's record. By default, the identity of the current legal entity is entered automatically. This identity can bei edited, e.g. by adding more details (e.g. name of department) or completely overwriting it with another name.

For each authority/organisation that intends to include an annotation on the study summary, a separate annotation record must be prepared.

Annotation status

This field is for indicating the status of annotation (i.e. normally either "draft" or "final"; "other:" for special cases). The related text field is only active, if the picklist item "other:" is selected. To provide any further explanations on the other picklist items use the Remarks field.

Agreement with applicant's summary

If the authority agrees in principle with the applicant's summary, select this checkbox. Comments, particularly in case of disagreement, should be included in the field Remarks.

Data waiver acceptable?

If the applicant claims a data waiver, indicate if the authority agrees with applicant's request. Any supplementary remarks field have to be included in the Remarks field. If applicable, indicate what action will be required.

Reliability

The authority may agree with the applicant's summary, but change the reliability suggested by the applicant. Adopt submitter's proposal if you agree. Otherwise enter the reliability score as judged at your discretion based on the criteria described in the relevant guidance documents (1 = Reliable without restrictions; 2 = Reliable with restrictions; 3 = Not reliable; 4 = Not assignable). Leave the field empty if this indicator is not applicable, e.g. if a record does not include a study summary, but any other information. The "other:" option may be selected if this scoring system is not used.

Remarks

Enter any comments. As appropriate use the main headings of the Freetext template to structure your comments:

Delete the default headings for which no comments are made. Insert new lines and/or subheadings or field names to further substructure your comments as appropriate.

The following items are only relevant for some Endpoint study records in section 6 Ecotoxicological Information:

Cross-reference to other study

Adopt submitter's proposal if you agree. Otherwise delete or amend reference to another study or other studies that are relevant in the interpretation of test results, e.g. for supporting any conclusions. Amend the explanatory text as appropriate.

Conclusions

Adopt the submitter's proposal if you agree or revise as appropriate. This field may be obsolete, if the conclusions are given in the executive summary.

Executive summary

Adopt the submitter's proposal if you agree or revise as appropriate.

Attached regulatory authorities' evaluation

The Attached regulatory authorities' evaluation feature allows to upload any document containing an evaluation made by the regulatory authorities, if such a document is necessary in addition to the annotations included in the distinct fields of the annotation record. In principle, any file can be attached, e.g. a PDF or wordprocessing document.

In this chapter, instructions are given on how to manage annotation records.

D.4.9.6.2.1. Creating / editing annotation records in sections 0 - 3

Although sections 0 to 3 are technically handled as one record in IUCLID (see chapter D.4.6.1 Differences between sections 0 - 3 and sections 4 - 13), the annotation feature is provided for each subsection.

To add annotations related to a specific subsection

1. Open the respective subsection. Make sure it is displayed in the Data entry window and not only marked in the section tree.

2. Click the Add button on the Annotations toolbar.

3. In the Annotation template appearing, complete the appropriate fields.

4. Optionally, attach an evaluation document in field Attached regulatory authorities' evaluation.

5. Click the Save or Save with comment button if you wish to add any comment, which will appear in the modification history only.

To edit annotations

1. Click the annotations you wish to edit in the Annotations table.

2. Click the Edit button on the Annotations toolbar and edit any field(s) as desired.

3. Click the Save or Save with comment button if you wish to add any comment, which will appear in the modification history only.

By repeatedly executing the Add command several annotations can be added, e.g. for including comments from different regulatory authorities. Each set of annotations is displayed as one row in the annotations table as shown in the screenshot below.

To re-sort annotation instances in the annotations table you can use the clickable headers of the table:

1. Click in the header of the column by which you wish to sort the table. A sort triangle appears.

2. Click in the header repeatedly to change the sorting direction (i.e. alphabetically upwards or downwards) until the rows are sorted as expected.

Apart from the Add and Edit commands, the following additional functions are available for managing annotations either from the Annotations toolbar and/or on right-clicking in the table, which opens following menu:

• Print table command on right-click: To print the table directly to the printer selected.

• Copy table command on right-click: To copy the table into the clipboard of your operating system (e.g. MS Windows), from which you can paste it (Ctrl+V) into another application, e.g. a wordprocessing document. Note that it is not possible to copy a table to another Endpoint study record.

• Reset table command on right-click: To reset the original sort order of the annotations. Only relevant if they were resorted by clicking into any of the column headings.

• View command on right-click or from toolbar: To view the annotations.

• Export command on right-click or from toolbar: To export the annotation(s) marked in the table. To highlight several annotations, if any, hold down the Ctrl or Shift key and click in the corresponding annotations row.

• Delete command on right-click or from toolbar: To delete an annotation.

• Refresh command from toolbar: To refresh an annotations table. This is relevant if you work with a network multi-user application.

The following commands are only active in the Dossier layer (see chapter D.8.4 Annotating a Dossier), but not in the Substance dataset layer:

• Show/Hide associated annotations command from toolbar: To display or hide all annotations made in the raw data layer, i.e. in the Substance dataset used to create the Dossier. By default associated annotations are hidden.

  In annotation tables of a Dossier, referenced annotations appear green, while annotations added on the Dossier layer are in white.

• Go to referenced document command on right-click or from toolbar: To navigate to the associated annotation and hence, the record in the Substance dataset.

  Note

  The term "referenced document" here means a record in the raw data layer to which it is referred to in a Dossier. It should not be mistaken with "referenced record" (see chapter D.4.7.10 Referencing Endpoint study records to another Substance dataset).

D.4.9.6.2.2. Creating / editing annotation records in sections 4 - 13

In sections 4 to 13, annotations can be created for each endpoint study or summary record.

To add annotations related to a specific record

1. Open the respective record. Make sure it is displayed in the Data entry window.

2. Click the Add button on the Annotations toolbar.

3. In the Annotation template appearing, complete the appropriate fields.

4. Optionally, attach an evaluation document in field Attached regulatory authorities' evaluation.

5. Click the Save or Save with comment button if you wish to add any comment, which will appear in the modification history only.

To edit annotations

1. Open the respective subsection. Make sure it is displayed in the Data entry window.

2. Click the annotations you wish to edit in the Annotations table.

3. Click the Edit button on the Annotations toolbar and edit any field(s) as desired.

4. Click the Save or Save with comment button if you wish to add any comment, which will appear in the modification history only.

By repeatedly executing the Add command several annotations can be added, e.g. for including comments from different regulatory authorities. Each set of annotations is displayed as one row in the annotations table as shown in the screenshot below.

To re-sort annotation instances in the annotations table you can use the clickable headers of the table:

1. Click in the header of the column by which you wish to sort the table. A sort triangle appears.

2. Click in the header repeatedly to change the sorting direction (i.e. alphabetically upwards or downwards) until the rows are sorted as expected.

Note

For guidance on the fields provided in the Annotation template see chapter D.4.9.6.1 Principles of annotation records.

Apart from the Add and Edit commands, the following additional functions are available for managing annotations either from the Annotations toolbar and/or on right-clicking in the table, which opens following menu:

• Print table command on right-click: To print the table directly to the printer selected.

• Copy table command on right-click: To copy the table into the clipboard of your operating system (e.g. MS Windows), from which you can paste it (Ctrl+V) into another application, e.g. a wordprocessing document. Note that it is not possible to copy a table to another Endpoint study record.

• Reset table command on right-click: To reset the original sort order of the annotations. Only relevant if they were resorted by clicking into any of the column headings.

• View command on right-click or from toolbar: To view the annotations.

• Export command on right-click or from toolbar: To export the annotation(s) marked in the table. To highlight several annotations, if any, hold down the Ctrl or Shift key and click in the corresponding annotations row.

• Delete command on right-click or from toolbar: To delete an annotation.

• Refresh command from toolbar: To refresh an annotations table. This is relevant if you work with a network multi-user application.

The following commands are only active in the Dossier layer (see chapter D.8.4 Annotating a Dossier), but not in the Substance dataset layer:

• Show/Hide associated annotations command from toolbar: To display or hide all annotations made in the raw data layer, i.e. in the Substance dataset used to create the Dossier. By default associated annotations are hidden.

  In annotation tables of a Dossier, referenced annotations appear green, while annotations added on the Dossier layer are in white.

• Go to referenced document command on right-click or from toolbar: To navigate to the associated annotation and hence, the record in the Substance dataset.

  Note

  The term "referenced document" here means a record in the raw data layer to which it is referred to in a Dossier. It should not be mistaken with "referenced record" (see chapter D.4.7.10 Referencing Endpoint study records to another Substance dataset).