EASIS - Brief Introduction - EURL ECVAM

Transcription

EASIS - Brief Introduction - EURL ECVAM
EASIS - Brief Introduction
EASIS Background ......................................................................................................................................................1
EASIS First Steps .........................................................................................................................................................2
EASIS Search Functions ..............................................................................................................................................2
Simple Search .........................................................................................................................................................2
Advanced Search ....................................................................................................................................................5
EASIS Study Questionnaires .......................................................................................................................................8
Questionnaire meta-data .....................................................................................................................................10
Questionnaire data ..............................................................................................................................................11
EASIS Background
EASIS, the Endocrine Active Substances Information System, is a web-based application open to the public for
query and review of (eco)toxicological information about chemicals, with an emphasis on endocrine-related
endpoints.
The starting point of EASIS was the EAS Database1 created by the European Commission's Environment
Directorate-General (DG ENV) in the 2000s. A new application, EASIS, was developed and the data from the DG
ENV DB were migrated into EASIS. More data will be added over time, in a first step by the JRC, then by a
crowdsourcing community.
1
see https://eurl-ecvam.jrc.ec.europa.eu/laboratories-research/endocrine_disrupters/files_eds/database.zip
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EASIS First Steps
The URL https://easis.jrc.ec.europa.eu leads to the EASIS main page:
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The Register button leads to a dialogue in which a user account for EASIS can be requested. Please note
that for searching the database a user account is not necessary. Registering and logging in will become
relevant once write access is available.
The Glossary and the Links buttons lead to pages with background information.
The Search button leads to the current main functionality, i.e. querying and reviewing studies in EASIS.
EASIS Search Functions
Clicking on the search tab in the main screen leads to two search options:
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Simple Search
Advanced Search
Simple Search
The Simple Search is the default option selected:
Any search term can be entered into the search field, and once the
button is clicked, all DB fields will be
examined whether the word appears there, and as a consequence, the Result Set is shown:
Example: "Ovaries" are entered as search term:
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This sample Result Set shows that 19 studies are in the database in which the term "ovaries" appears (in any
field).
The Result Set features the following fields:
Result Set fields: Test Type and Target
All studies in EASIS are of one of the following four types:
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In-vivo mammals
In-vivo humans (epidemiology)
In-vivo ecotox
In-vitro
Later we will see that EASIS study data are displayed in one of four possible "Questionnaires" which are forms
that correspond to these four types.
Result Set fields: Substance and CAS Number
Indicates the substance that the study is about.
Result Set field: General Effect Type
Indicates what kind of effect was observed in the study. In most cases this field also contains the search term.
Result Set field: Test Guideline
Indicates what Test Guideline (OECD or other) was followed in the study, if any.
Result Set field: Metric Endpoint
Displays relevant numerical results of the study.
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Result Set field: Matched Fields
By clicking the arrow-down symbol in the "Matched Fields" column…
… columns to be displayed/not displayed in the Result Set can be selected:
The "Matched Field" column features two clickable icons:
- the "View matched fields" icon, which displays the field in which the search term appeared (i.e. the reason
why the study is displayed in the Result Set), and
- the "View" icon, which leads to the display of the full study report, see chapter "EASIS Study
Questionnaires".
Export Result Set
Clicking the
button in the right hand bottom corner of the screen activates the Export dialogue; it is
possible to export the Result Set into an Excel or CSV file. Please note that the Excel export contains, per row in
the Result Set, also a direct URL link to the specific study back in EASIS.
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Filter Result Set
The row of column headings features Filter fields. When selecting a filter term from one or more of the filter
fields…
… (e.g. "Ecotox" in the Target field), only the studies from within the Result Set that deal with "Ecotox" are
shown:
Filtering can be used to drill into the search result and get a less overwhelming Result Set.
Advanced Search
Clicking the
tab activates the Advanced Search.
Search criteria can be entered in one or more of the search fields, and once the
button is clicked, the DB
is searched for the occurrence of each of the search criteria, and the Result Set is shown:
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Search Example: CAS number = 63-25-2
The Result Set shows 97 studies for this substance (Carbaryl).
The columns of the Result Set correspond to the ones of the Simple Search (see above). Filtering and exporting
are also the same as in the Simple Search.
As is the case with the Simple Search, clicking the
View icon in the Matched Fields column leads to a detailed
view of the selected study. For more details, see the chapter "EASIS Study Questionnaires".
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Search Example: Test Guideline = OECD Guideline 421:
The Result Set shows 4 studies for this Guideline.
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Search Example: CAS number = 72-43-5 & Study Type = In vitro
The Result Set shows 13 in-vitro studies for this substance (Methoxychlor).
EASIS Study Questionnaires
The Result Sets of both the Simple Search and the Advanced Search display one row per retrieved study. Next to
each of these rows, the
EASIS Brief Introduction
View icon leads to the display of the full study report.
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Clicking the View icon next to any study…
… displays the main Study screen:
Study Data in EASIS are displayed in an interconnected series of screens that are called Questionnaires2.
The questionnaires themselves are a long series of data display forms (left hand side of the screen, see chapter
"Questionnaire data"); the right hand side of the screen shows assorted questionnaire meta-data (see next
section).
2
The meaning of this term will become more obvious once the public Data Entry functionality is made available, as users will be guided through data
capturing via a questionnaire-like model; the same questionnaires are already now used for data display.
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Questionnaire meta-data
The questionnaire meta-data shows information about general overview data concerning the selected study:
Questionnaire meta-data element Actions
The section "actions" in the questionnaire meta-data shows icons for all manipulations that are possible with
the current study (questionnaire). In most cases the only selectable action while not logged (i.e. in Read Access
mode) on is "Close" (the study).
Questionnaire meta-data element Endpoints
The EASIS data model supports the association between an EASIS questionnaire and the OECD Harmonised
Template3 (OHT) format. Each questionnaire is linked to one distinct OHT, which makes subsequent re-use of
the data in other environments and applications easier: OHTs are used in a number of regulatory programmes
as the data reporting and exchange format, most prominently REACH4. Inserting data into EASIS makes them
automatically compatible with these reporting standards for possible re-use in a regulatory context.
3
The OECD Harmonised Templates (OHTs) are standard data formats for reporting studies done on chemicals to determine their properties or effects on
human health and the environment. For more details go to http://www.oecd.org/ehs/templates/
4
REACH is a regulation of the European Union, adopted to improve the protection of human health and the environment from the risks that can be posed
by chemicals.. It also promotes alternative methods for the hazard assessment of substances in order to reduce the number of tests on animals. For more
see http://echa.europa.eu/regulations/reach
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Possible associations between Questionnaire types and OHTs are as follows:
Questionnaire meta-data element Questionnaire information
Several fields give information about relevant data concerning the questionnaire, like test type, target, creation
date, etc.
The study status is "published" for all publicly visible questionnaires. Other statuses become relevant once the
write functionality has been made available.
Questionnaire data
Each questionnaire consists of several sections:
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The main sections (green frame in the diagram above) are the same across all questionnaire types:
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Materials and Methods
Results
Reference
Discussion and Conclusion
Attachments
Depending on the questionnaire type (in-vivo mammal, in-vivo human, in-vivo ecotox, in-vitro), different
subsections exist for each of the five main sections, e.g. for the Materials and Methods section in the "in-vivo
mammal" as shown above the following subsections exist:
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General method information
Test materials
Test animals
Details on test animals and environmental conditions
Administration
Protocol details
Observations and examinations performed and frequency
Browsing through the study by clicking the relevant tabs gives a quick overview. Please note that the walkthrough below only shows a small fraction of the data fields EASIS actually manages.
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General method information, Test Guideline
The Test Guideline is described in the General method information tab, OECD Guideline 421 in this case.
Test Material
The Test Material is Bisphenol A.
Test animals
The Test Animals were rats.
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Administration
The dose was 1000 mg/kg body weight per day, the route of administration was oral.
Result, Endpoint, Effect
The General Effect Type is "Increased number of corpora lutea".
Reference, Bibliographic Information
The Bibliographic information shows the original source of the data. The secondary source, in this case, indicates
that this study has been imported/migrated from the original DG ENV DB (see chapter "EASIS Background").
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Discussion and Conclusions
The conclusion is that there is a suspected endocrine effect.
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