Generic part 'Administrative data'

This table shows all fields that appear in each OECD Harmonised Template, under the main heading ADMINISTRATIVE DATA. The underlying fields are for identifying the purpose of the record (e.g. 'key study'), the type of result (e.g. 'experimental study'), data waiving indication (if any), reliability indication, and flags for specifying the regulatory purpose envisaged and/or any confidentiality restrictions. This kind of data characterises the relevance of a study summary and should therefore be displayed at the top of each endpoint study record on any user interface.

Note

The order numbers shown in column 1 (Field number) are the same in each endpoint template. 'xx.xx.xx' stands for the respective section number.

Modification History is no data entry field, but just denotes the beginning of this block of fields.

Table: Administrative data 

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

SExx.xx.xx.0000

Record ID

[Record ID]

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

Remarks:

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.data.EndpointStudyRecord:

/documentReferencePK

/uuid

SExx.xx.xx.0001

Submission substance ID

[Submission substance ID]

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

Remarks:

No entry field. Automatic display (read-only) of the primary identifiers of the substance being implicitely deducted (i.e. link to substance administration section of a given submission or data set). Should appear in the header of each record.

 

The unique ID(s) of the chemical substance to which this submission, i.e. data set, is associated. System-generated display of relevant (e.g. first three) substance identifiers indicated in the data set definition. Read-only.

eu.eca.iuclid.common.business.data.EndpointStudyRecord:

/ownerRef

SExx.xx.xx.0002

Record identifier

[Record identifier]

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

By default, a system generated record description including a consecutive record number is entered. This can optionally either be overwritten or supplemented with a user-defined remark, which can be of further help for easier navigating to that record or to mark a record for internal purposes. For instance, if a data entry screen is for more than one data point, you can add information that allows to immediately identify what data requirement a given record addresses. Example: '(subchronic; rat)'. You may also include a short form of the bibliographic reference, e.g. '(Author X , 1995)', if this is considered helpful in navigating to specific records.

Consult any programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) on how to use this field.

Text-type identification of a record for use in a record navigator.

eu.eca.iuclid.common.business.data.EndpointStudyRecord:

/name

[N/A]

Modification history

[Modification history]

  1. HEAD BLOCK
  2. Block label
  3. g001
  4. 0
  5. 1
  6. [N/A]

Remarks:

Read-only; no context-sensitive help text

 

Heading of field block 'Modification history'

 

SExx.xx.xx.0050

Date

[Date]

  1. TEXT
  2. TIMESTAMP
  3. g001
  4. 1
  5. 1
  6. [N/A]

Remarks:

A system-generated date (without time) 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.data.EndpointStudyRecord:

/modificationHistory

/modifications

/date

SExx.xx.xx.0060

Author

[Author]

  1. STRING-255
  2. STRING/255
  3. g001
  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.data.EndpointStudyRecord:

/modificationHistory

/modifications

/modificationBy

SExx.xx.xx.0070

Remarks

[Remarks]

  1. STRING-255
  2. STRING/255
  3. g001
  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.data.EndpointStudyRecord:

/modificationHistory

/modifications

/comment

SExx.xx.xx.0110

Flags

[Flags]

  1. DATA PROTECTION
  2. Block label
  3. gFLAGS
  4. 1
  5. 1
  6. [N/A]
 

These flags can be used to mark a record or a field for the purpose of potentially excluding it from an export file, a dossier or other report. Verify the default settings (if any) or select the appropriate level of confidentiality or of restriction to specific regulatory programmes.

 

eu.eca.iuclid.common.business.data.EndpointStudyRecord:

/dataProtection

SExx.xx.xx.0111

Confidentiality flag

[Confidentiality flag]

  1. LIST-CLOSED
  2. STRING/255
  3. gFLAGS
  4. 1
  5. 1
  6. N64

Picklist Values:

CBI (confidential business information) || IP (intellectual property) || no PA (not public available)

A flag can be used to mark a record for the purpose of excluding it from a report or export file.

An empty field means 'non confidential' by default, i.e. data can be exchanged and can be made publicly available. If applicable set the respective flag for indicating either one of the following reasons of confidentiality:

(i) CBI (confidential business information): The data must not be provided to other companies or disseminated to the public.

(ii) IP (intellectual property): The data should only be provided to other companies when they are trusted (e.g. consortia or with letter of access); the data must not be disseminated to the public.

(iii) no PA (not public available): The data can be provided to other companies, but must not be disseminated to the public.

Consult any programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) on how to use this field.

Flag for indicating either one of the following reasons of confidentiality: (i) CBI (confidential business information): The data must not be provided to other companies or disseminated to the public. (ii) IP (intellectual property): The data should only be provided to other companies when they are trusted (e.g. consortia or with letter of access); the data must not be disseminated to the public. (iii) no PA (not public available): The data can be provided to other companies, but must not be disseminated to the public.

eu.eca.iuclid.common.business.data.EndpointStudyRecord:

/dataProtection

/confidentiality

SExx.xx.xx.0112

Justification for confidentiality

[Justification for confidentiality]

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

As appropriate, include a justification of the confidentiality flag set.

Justification for confidentiality.

eu.eca.iuclid.common.business.data.EndpointStudyRecord:

/dataProtection

/justification

SExx.xx.xx.0113

Regulatory purpose

[Regulatory purpose]

  1. LIST-OPEN
  2. STRING/255
  3. gFLAGS
  4. 11
  5. 1
  6. N78

Picklist Values:

EU: BPD || EU: PPP || EU: REACH || CA: CEPA || CA: PCPA || JP: CSCL || OECD: HPVC || US: EPA HPVC || US: FIFRA || US: TSCA || other:

Remarks:

Actually, this is a multiple-choice list where items can be selected arbitrarily but each item can only be selected once.

Indicate one or more regulatory or other programme(s) for which the data are used.

Indication of the regulatory or other programme for which the data are used.

eu.eca.iuclid.common.business.data.EndpointStudyRecord:

/dataProtection

/regulatoryPurposes[ ]

/value

SExx.xx.xx.0114

Regulatory purpose

[no label]

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

Remarks:

This field holds the 'other regulatory purpose' in case the text 'other:' was selected in SExx.xx.xx.0113

  

eu.eca.iuclid.common.business.data.EndpointStudyRecord:

/dataProtection

/regulatoryPurposes[ ]

/otherValue

SExx.xx.xx.0120

Purpose flag

[Purpose flag]

  1. LIST-CLOSED
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. Y14-3

Picklist Values:

key study || supporting study || weight of evidence

Indicate whether this record reflects a key study, supporting study or adds to a weight of evidence analysis. Assigning a flag may be required by the respective regulatory programme or otherwise be useful as filter for printing or exporting only flagged records, e.g. records with flags 'Key study', or any combination of flags.

Explanation:

- Key study: In general, a Key Study is the study that has been identified as most suitable to describe an endpoint from the perspective of quality, completeness and representatitivity of data.

- Supporting study: Any other adequate study that is considered supportive for the key study or key studies.

- Weight of evidence: A record that contributes to a weight of evidence justification for the non-submission of a particular (adequate) study. The weight of evidence justification is normally endpoint-related, i.e. is based on all records flagged that way. However, a short reasoning for why a given record is flagged should be provided in field 'Rationale for reliability incl. deficiencies'. Consult any programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) on how to use this field.

Flag for marking the purpose of a record in terms of use for hazard or risk assessment. Useful as filter for printing or exporting only records with a given flag or combination of flags.

eu.eca.iuclid.common.business.data.EndpointStudyRecord:

/purposeFlag

SExx.xx.xx.0130

Robust study summary

[Robust study summary]

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

Picklist Values:

yes || no

Set this flag if required by the respective regulatory programme or if otherwise useful as filter for printing or exporting records flagged as 'Robust Study Summary' or in combination with 'Purpose' flag.

Explanation: The term 'Robust Study Summary' is actually used only to describe the technical content of a very detailed summary of an experimental study or of any other relevant information. It is a priori no synonym with the term 'Key study', although a key study should usually be submitted in the form of Robust Study Summary. However, a Robust Summary may also be useful for other adequate studies that are considered supportive of the key study or even for inadequate studies if they can be used for a weight-of-evidence analysis. Also for studies that are flawed, but indicate critical results, Robust Study Summaries highlighting the weaknesses of the studies need to be elaborated.

Consult any programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) on how to use this field.

Flag for marking a robust study summary.

eu.eca.iuclid.common.business.data.EndpointStudyRecord:

/robustStudy

SExx.xx.xx.0140

Used for classification

[Used for classification]

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

Picklist Values:

yes || no

Set this flag if required by the respective regulatory programme or if otherwise useful as filter for printing or exporting records flagged as 'Used for classification'.

Explanation: In some use cases it may be necessary to indicate those records that are used for the classification of that substance, e.g. according Directive 67/548/EEC. If not relevant, disregard this field.

Consult any programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) on how to use this field.

Flag for indicating that information of a record is used for the classification of that substance.

eu.eca.iuclid.common.business.data.EndpointStudyRecord:

/usedForClassification

SExx.xx.xx.0150

Used for MSDS

[Used for MSDS]

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

Picklist Values:

yes || no

Set this flag if required by the respective regulatory programme or if otherwise useful as filter for printing or exporting records flagged as 'MSDS information'.

Explanation: 'MSDS' stands for Material Safety Data Sheet. In some use cases it may be necessary to indicate those records that are used for the compilation of MSDS information. If not relevant, disregard this field.

Consult any programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) on how to use this field.

Flag for indicating that information of a record is used for Material Safety Datasheet (MSDS).

eu.eca.iuclid.common.business.data.EndpointStudyRecord:

/usedForMSDS

SExx.xx.xx.0160

Data waiving

[Data waiving]

  1. LIST-CLOSED
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. Z02

Picklist Values:

study technically not feasible || study scientifically unjustified || exposure considerations || other justification

If appropriate, indicate that data waiving, i.e. the non-submission of a particular study, is considered justified. If so, select appropriate reason from the picklist (e.g. 'study technically not feasible' or 'other justification') and include a more detailed reasoning in field 'Justification for data waiving'.

If more than one reason can be indicated, create separate records for each.

If a data entry screen covers more than one data requirements, complete the relevant fields to specify the data waiver. For instance indicate species (e.g. rat) and test type (e.g. chronic) for repeated dose toxicity studies.

Consult any programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) on how to use data waivers.

Indicator of data waiving.

eu.eca.iuclid.common.business.data.EndpointStudyRecord:

/dataWaiving

/value

SExx.xx.xx.0170

Justification for data waiving

[Justification for data waiving]

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

If a data waiver has been indicated, give an appropriate justification. Explain why no new study needs be conducted despite of a lack of information that would fulfill the general requirements of the respective legislation. For instance, 'Data waiving: exposure considerations' should be justified by referring to exposure scenario analysis or other relevant information.

Justification and rationale for the data waiver.

eu.eca.iuclid.common.business.data.EndpointStudyRecord:

/dataWaivingJustification

SExx.xx.xx.0180

Study result type

[Study result type]

  1. LIST-OPEN
  2. STRING/255
  3. [N/A]
  4. 1
  5. 1
  6. Z05

Picklist Values:

experimental result || experimental study planned || estimated by calculation || read-across based on grouping of substances (category approach) || read-across from supporting substance (structural analogue or surrogate) || (Q)SAR || other: || no data

Select appropriate indication for type of result. In case of read-across, follow the instructions related to the respective legislation as to whether the (robust) study summary should be entered in a separate data set defined for the read-across substance.

If it is indicated that an experimental study is planned (in some legislations also defined as 'undertaking of intended submission'), the submitter should provide the basic data of the intended study in the respective fields as far as known (e.g. Test type, Test guideline or Principles of method if other than guideline, Species etc.). The information provided should be detailed enough to allow the Evaluator to make a decision on the testing proposal. In addition to data entered in fields, you may attach further details in field 'Attached background material'.

Consult any programme-specific guidance (e.g. OECD HPVC, Pesticides NAFTA or EU REACH) on how to use this field.

Indicator showing whether the study result represents a measured or an estimated value.

eu.eca.iuclid.common.business.data.EndpointStudyRecord:

/studyResultType

/value

SExx.xx.xx.0181

Study result type

[no label]

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

eu.eca.iuclid.common.business.data.EndpointStudyRecord:

/studyResultType

/otherValue

SExx.xx.xx.0190

Study period

[Study period]

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

If applicable indicate the period during which the study was conducted, i.e. start and end date, using an unambiguous date format, e.g. 'From 12 MAY 1999 to 15 AUG 2000' or 'From May 12, 1999 to Aug. 15, 2000'.

Note: Independent of the study period the in-life period (i.e. the phase of a study following treatment in which the test system is alive/growing) may have to be specified for some toxicology endpoints.

Period during which the study was conducted, with start and end date.

eu.eca.iuclid.common.business.data.EndpointStudyRecord:

/studyPeriod

SExx.xx.xx.0200

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.data.EndpointStudyRecord:

/reliability

/value

SExx.xx.xx.0201

Reliability

[no label]

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

eu.eca.iuclid.common.business.data.EndpointStudyRecord:

/reliability

/otherValue

SExx.xx.xx.0210

Rationale for reliability incl. deficiencies

[Rationale for reliability incl. deficiencies]

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

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 and hence, the adequacy of data at the discretion of the person preparing the study summary.

Note: Particularly if reliability scores 2 or 3 are assigned, indicate the concrete arguments for defending a study or relevant deficiencies, e.g. 'Method not acceptable: no vehicle control used or not reported; considerably longer life-time in control group as compared to treatment groups'.

Comments about how the reliability of data was determined and other related remarks, including indication and interpretation of arguments defending a study or deficiencies if relevant for justifying whether study was downgraded or not.

eu.eca.iuclid.common.business.data.EndpointStudyRecord:

/rationalReliability