Generic part 'Annotations'

The Annotations template provides guidance on how annotation records should be designed which can be used for making annotations on any single endpoint study record. Annotation records are primarily designed for the use by regulatory authorities, when evaluating the data submitted by the registrant. However, they may also be used by the registrants, for example, in the context of the internal review process.

Annotation records can support the internal review and revision process particularly when several persons are involved in the preparation of a submission substance dataset. Instead of making any changes in the endpoint records, which may even be write-protected, comments can be included in annotation records related to the endpoint records. Any annotation record should have its own record ID, which is associated to one specific endpoint record which in turn has also a unique record ID. It will therefore also be possible to export and import only annotation records.

The following Annotations template focuses on endpoint study records. Other types of annotations templates may be developed towards other elements in a database system.

Table: Annotations

Field number

Field description

[Field label]

  1. Field type
  2. Data type
  3. Group ID
  4. Max occ.
  5. Detail level
  6. Picklist code

Remarks, Picklist, Freetext template

Help text

Explanation for use in Data Element Dictionary (DED)

XML Schema

A00.00.0010

Record ID

[Record ID]

  1. TEXT
  2. UUID
  3. [N/A]
  4. 1
  5. 1
  6. [N/A]

Remarks:

UUID (Universal Unique ID) generated by the system. This is a worldwide unique number allocated when a record is created. It cannot be modified and will follow the object during all its life time.

Read-only; no context-sensitive help text

 

UUID (Universal Unique ID) generated by the system. This is a worldwide unique number allocated when a record is created. It cannot be modified and will follow the object during all its life time.

eu.eca.iuclid.common.business.annotation.Annotation:

/documentReferencePK

/uuid

A00.00.0020

Linked record ID

[Linked record ID]

  1. TEXT
  2. UUID
  3. [N/A]
  4. 1
  5. 1
  6. [N/A]

Remarks:

Automatic entry and display of the UUID pair (Universal Unique ID) of the corresponding endpoint record the annotation record refers to.

Read-only; no context-sensitive help text

 

UUID (Universal Unique ID) of the linked record generated by the system.

eu.eca.iuclid.common.business.annotation.Annotation:

/referencedDocument

A00.00.0050

Linked record type

[Linked record type]

  1. TEXT
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. [N/A]

Remarks:

Automatic entry and display of the type of data object to which the annotation belongs, e.g. endpoint record, endpoint summary record, dossier, reference substance …)

 

A system-generated entry indicating the type of the linked record. Read-only field.

eu.eca.iuclid.common.business.annotation.Annotation:

/referencedDocument

A00.00.0060

Linked record date

[Linked record date]

  1. TEXT
  2. TIMESTAMP
  3. [N/A]
  4. 1
  5. 1
  6. [N/A]

Remarks:

Automatic entry and display of the version (i.e. timestamp) of the referenced object.

 

A system-generated date representing the date of the linked record. Read-only field.

eu.eca.iuclid.common.business.annotation.Annotation:

/referencedDocument

[N/A]

Modification history

[Modification history]

  1. HEAD BLOCK
  2. Block label
  3. g820
  4. 0
  5. 1
  6. [N/A]

Remarks:

Read-only; no context-sensitive help text

 

Heading of field block 'Modification history'

 

A00.00.0080

Date

[Date]

  1. TEXT
  2. TIMESTAMP
  3. g820
  4. 1
  5. 1
  6. [N/A]

Remarks:

A system-generated date representing the date a record was created or modified. Read-only field.

Format should be non-ambiguous, i.e. either '12 May 2001' or 'May 12, 2001' or '12-MAY-2001', but not '12/5/2001', as this can be interpreted to mean either 12 May or 5 December.

 

A system-generated date representing the date a record was created or modified. Read-only field.

eu.eca.iuclid.common.business.annotation.Annotation:

/modificationHistory

/modifications[ ]

/date

A00.00.0090

Author

[Author]

  1. TEXT
  2. STRING/255
  3. g820
  4. 1
  5. 1
  6. [N/A]

Remarks:

Some ID of IUCLID user who creates or modifies the record. System generated (based on login ID of the user).

 

Some ID of IUCLID user who created or modified the record. System generated (based on login ID of the user).

eu.eca.iuclid.common.business.annotation.Annotation:

/modificationHistory

/modifications[ ]

/modificationBy

A00.00.0100

Remarks

[Remarks]

  1. TEXT
  2. STRING/255
  3. g820
  4. 1
  5. 1
  6. [N/A]
 

As appropriate, include any remarks.

Remarks on Tracking of record creation and update.

eu.eca.iuclid.common.business.annotation.Annotation:

/modificationHistory

/modifications[ ]

/comment

A00.00.0110

Name of authority / organisation

[Name of authority / organisation ]

  1. TEXT
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. [N/A]
 

If not indicated automatically, either enter the identity of the regulatory authority or organisation manually or select it from the non-mandatory picklist.

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

Identity of authority or organisation evaluating or making comments on a submitter's record.

eu.eca.iuclid.common.business.annotation.Annotation:

/authority

A00.00.0120

Annotation status

[Annotation status]

  1. LIST-OPEN
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. N16

Picklist Values:

draft || final || other:

As appropriate, indicate the status of annotation (i.e. normally either 'draft' or 'final'; 'other:' for special cases). You can provide any further explanations in the field 'Remarks' (e.g. state for which decision the annotation was made).

Indicator specifying the status of annotation (i.e. draft or released).

eu.eca.iuclid.common.business.annotation.Annotation:

/status

/value

A00.00.0121

Annotation status

[no label]

  1. OTHERTEXT
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. [N/A]
   

eu.eca.iuclid.common.business.annotation.Annotation:

/status

/otherValue

A00.00.0130

Agreement with applicant's summary

[Agreement with applicant's summary]

  1. CHECKBOX
  2. BOOLEAN
  3. [N/A]
  4. 1
  5. 1
  6. Z38

Picklist Values:

yes || no

Indicate if the authority agrees in principle with the applicant's summary. Comments, particularly in case of disagreement, should be included in the field 'Remarks'.

Indication whether the evaluator agrees with the applicant's summary.

eu.eca.iuclid.common.business.annotation.Annotation:

/endpointInfo

/agreementWithApplicants

A00.00.0150

Data waiver acceptable?

[Data waiver acceptable?]

  1. LIST-OPEN
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. Z12

Picklist Values:

acceptable || unacceptable and action required || not applicable || other:

If the applicant claims a data waiver, indicate if the authority agrees with applicant's request. Any remarks on the decision can be entered in the field 'Remarks'. For example, for pesticides the context under which the decision was made can be specified, e.g. the particular uses, application method and rate. If applicable indicate what action will be required.

Indication whether the submitter's request of data waiving is accepted by the evaluator. In the suppl. remarks field, specify the context under which the decision was made.

eu.eca.iuclid.common.business.annotation.Annotation:

/endpointInfo

/dataWaiverAcceptable

/value

A00.00.0151

Data waiver acceptable?

[no label]

  1. OTHERTEXT
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. [N/A]
   

eu.eca.iuclid.common.business.annotation.Annotation:

/endpointInfo

/dataWaiverAcceptable

/value

A00.00.0160

Reliability

[Reliability]

  1. LIST-OPEN
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. A36

Picklist Values:

1 (reliable without restriction) || 2 (reliable with restrictions) || 3 (not reliable) || 4 (not assignable) || other:

Enter reliability score as judged at your discretion. Leave 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.

Indication of the adequacy of data at the discretion of the person preparing the study summary. Defined scores: 1 = Reliable without restrictions; 2 = Reliable with restrictions; 3 = Not reliable; 4 = Not assignable.

eu.eca.iuclid.common.business.annotation.Annotation:

/endpointInfo

/reliability

/value

A00.00.0161

Reliability

[no label]

  1. OTHERTEXT
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. [N/A]
   

eu.eca.iuclid.common.business.annotation.Annotation:

/endpointInfo

/reliability

/otherValue

A00.00.0170

Remarks

[Remarks]

  1. TEXT-TEMPL
  2. STRING/32768
  3. N
  4. 1
  5. [N/A]
  6. [N/A]

Freetext Template:

ADMINISTRATIVE DATA

DATA SOURCE

GUIDELINES AND QUALITY ASSURANCE

MATERIALS AND METHODS

RESULTS AND DISCUSSION

VALIDITY CRITERIA

FULFILLED VERIFICATION OF STATISTICS

RATIONALE FOR RELIABILITY INCL. DEFICIENCES

OVERALL REMARKS,

ATTACHMENTS

Enter any comments. As appropriate use the main headings of the freetext template to structure your comments. Where comments on specific endpoint fields are included, specify the respective field name.

Explanations:

VALIDITY CRITERIA FULFILLED: If such a field is provided in the corresponding endpoint template, indicate whether validity criteria given by test guideline have been fulfilled or not. Use supplementary remarks field for indicating the criteria and entering remarks. Clearly indicate if the criteria used are not consistent with those given by the test guideline. If so, give justification in field 'Rationale for reliability incl. deficiences' as to why this study summary is considered reliable.

VERIFICATION OF STATISTICS: If applicable, report the statistical methods used by the reviewer to verify the applicant's results.

RATIONALE FOR RELIABILITY INCL. DEFICIENCES: Adopt submitter's proposal if you agree. Otherwise describe rationale for reliability score chosen considering the possible impact of deficiencies and/or implications on test results. The term reliability defines the inherent quality of a test report or publication. Give reasons if necessary, e.g. if a study is considered acceptable despite a poor reliability indicator. Discuss the relevance of deficiencies and indicate if repeat of study is necessary. Give reasons as to why submitter's version of study summary is considered unacceptable or indicate if amendments have been made by authority. Indicate if another (more up-to-date) guideline was used as compared to the one indicated by the applicant to evaluate this study summary.

Details on description and specification of the actual test material.

eu.eca.iuclid.common.business.annotation.Annotation:

/endpointInfo

/remarks

A00.00.0180

Cross-reference to same study

[Cross-reference to same study]

  1. TEXTAREA
  2. STRING/255
  3. N
  4. 1
  5. [N/A]
  6. [N/A]
 

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 explanatory text as appropriate.

A cross-reference to another study or other studies including explanatory text on why other results are relevant in the interpretation of the results of a given study, e.g. for supporting any conclusions.

eu.eca.iuclid.common.business.annotation.Annotation:

/endpointInfo

/crossReferenceToAnotherStudy

A00.00.0190

Conclusions

[no label]

  1. TEXTAREA
  2. STRING/32768
  3. N
  4. 1
  5. [N/A]
  6. [N/A]
 

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

Any conclusions either as adapted from the study report / publication, submitter's conclusions or indicated by the evaluator.

eu.eca.iuclid.common.business.annotation.Annotation:

/endpointInfo

/conclusion

A00.00.0200

Executive summary

[Executive summary]

  1. RICHTEXT
  2. STRING/256000
  3. N
  4. 1
  5. [N/A]
  6. [N/A]

REMARKS:

See Annex 3 for available predefined executive summaries.

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

Executive summary in which the relevant aspects of the study including the conclusions reached are briefly summarised.

eu.eca.iuclid.common.business.annotation.Annotation:

/summary

A00.00.0210

Attached document

[Attached document]

  1. ATTACHMENT
  2. STRING/32768
  3. N
  4. 1
  5. [N/A]
  6. [N/A]
 

Upload file by clicking the upload icon. As appropriate, enter any additional information, e.g. language. The file name is displayed after uploading the document.

File name of document uploaded, i.e. attached. No restriction as to file type.

eu.eca.iuclid.common.business.annotation.Annotation:

/attachmentRef