Difference between revisions of "Object types"

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<p style="color:blue; text-align:right"><small>'''''Last updated: 19/04/2022'''''</small></p>
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The object type provides a more detailed categorisation of a data object, and is a concept taken from DataCite, where it is known as the ‘ResourceType’. Within DataCite the categories are not explicitly defined, but the recommendation is for any type to be combined with the overall class to form a binomial classification, e.g. Dataset / IPD final analysis dataset, or Text / Journal Article.  
 
The object type provides a more detailed categorisation of a data object, and is a concept taken from DataCite, where it is known as the ‘ResourceType’. Within DataCite the categories are not explicitly defined, but the recommendation is for any type to be combined with the overall class to form a binomial classification, e.g. Dataset / IPD final analysis dataset, or Text / Journal Article.  
 
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| 100 || Journal article abstract || style="padding-bottom:10px;" | A journal citation and abstract, usually on-line as a web page, e.g. within PubMed. || Journal article || style="text-align:center;" | true || style="text-align:center;" | ECRIN
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| 100 || Journal article abstract || style="padding-bottom:10px;" | A journal citation and abstract, usually on-line as a web page, e.g. within PubMed. || Journal article || style="text-align:center;" | false || style="text-align:center;" | ECRIN
  
 
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| 13 || Trial registry entry || style="padding-bottom:10px;" | Summary of the study and its aims, posted prospectively or retrospectively to a public registry. || Trial registry entry || style="text-align:center;" | true || style="text-align:center;" | ECRIN
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| 13 || Trial registry entry || style="padding-bottom:10px;" | Summary of the study and its aims, posted prospectively or retrospectively to a public registry. || Trial registry entry || style="text-align:center;" | false || style="text-align:center;" | ECRIN
  
 
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| 24 || Trial master file contents list || style="padding-bottom:10px;" | A listing of the documents expected within a trial master file, and their organisation, in electronic and / or paper form. || Other study resource || style="text-align:center;" | true || style="text-align:center;" | ECRIN
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| 24 || Trial master file contents list || style="padding-bottom:10px;" | A listing of the documents expected within a trial master file, and their organisation, in electronic and / or paper form. || Other study resource || style="text-align:center;" | false || style="text-align:center;" | ECRIN
  
 
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| 25 || Data monitoring committee report|| style="padding-bottom:10px;" | A report concerning the safety or efficacy of a study, from independent experts. Often containing recommendations about the continuation of the study. || Other study resource || style="text-align:center;" | true || style="text-align:center;" | ECRIN
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| 25 || Data monitoring committee report|| style="padding-bottom:10px;" | A report concerning the safety or efficacy of a study, from independent experts. Often containing recommendations about the continuation of the study. || Other study resource || style="text-align:center;" | false || style="text-align:center;" | ECRIN
  
 
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| 83 || Bibliography || style="padding-bottom:10px;" | A list of publications making up a bibliography relevant to the study, but not necessarily generated or triggered by the study. || Other study resource || style="text-align:center;" | true || style="text-align:center;" | ECRIN (BioLINCC)
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| 83 || Bibliography || style="padding-bottom:10px;" | A list of publications making up a bibliography relevant to the study, but not necessarily generated or triggered by the study. || Other study resource || style="text-align:center;" | false || style="text-align:center;" | ECRIN (BioLINCC)
  
 
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| 86 || List of web links || style="padding-bottom:10px;" | A web page that includes a list of links to different items, e.g. individual CRFs. || Other study resource || style="text-align:center;" | true || style="text-align:center;" | ECRIN (BioLINCC)
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| 86 || List of web links || style="padding-bottom:10px;" | A web page that includes a list of links to different items, e.g. individual CRFs. || Other study resource || style="text-align:center;" | false || style="text-align:center;" | ECRIN (BioLINCC)
  
 
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| 28 || Trial registry results summary || style="padding-bottom:10px;" | Summary of study results, as displayed in a trial registry. || Registry results summary || style="text-align:center;" | true || style="text-align:center;" | ECRIN
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| 28 || Trial registry results summary || style="padding-bottom:10px;" | Summary of study results, as displayed in a trial registry. || Registry results summary || style="text-align:center;" | false || style="text-align:center;" | ECRIN
  
 
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| 34 || Literature review || style="padding-bottom:10px;" | Publications referenced within the literature review undertaken prior to the study. || Other study resource || style="text-align:center;" | true || style="text-align:center;" | ECRIN (BioLINCC)
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| 34 || Literature review || style="padding-bottom:10px;" | Publications referenced within the literature review undertaken prior to the study. || Other study resource || style="text-align:center;" | false || style="text-align:center;" | ECRIN (BioLINCC)
  
 
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| 42 || Redacted protocol || style="padding-bottom:10px;" | A redacted version of the study protocol. || Study protocol || style="text-align:center;" | true || style="text-align:center;" | ECRIN (ClinicalTrials.gov)
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| 42 || Redacted protocol || style="padding-bottom:10px;" | A redacted version of the study protocol. || Study protocol || style="text-align:center;" | false || style="text-align:center;" | ECRIN (ClinicalTrials.gov)
  
 
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| 43 || Redacted SAP || style="padding-bottom:10px;" | A redacted version of the statistical analysis plan. || Statistical analysis plan || style="text-align:center;" | true || style="text-align:center;" | ECRIN (ClinicalTrials.gov)
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| 43 || Redacted SAP || style="padding-bottom:10px;" | A redacted version of the statistical analysis plan. || Statistical analysis plan || style="text-align:center;" | false || style="text-align:center;" | ECRIN (ClinicalTrials.gov)
 
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Latest revision as of 14:51, 10 May 2022

Last updated: 19/04/2022

The object type provides a more detailed categorisation of a data object, and is a concept taken from DataCite, where it is known as the ‘ResourceType’. Within DataCite the categories are not explicitly defined, but the recommendation is for any type to be combined with the overall class to form a binomial classification, e.g. Dataset / IPD final analysis dataset, or Text / Journal Article.

In the MDR system this recommendation is made into a mandatory requirement, i.e. all object types must be associated with a ‘parent’ object class. Of the 117 object types currently defined, 70 are types of text objects (35 defined by CASRAI, 35 defined by ECRIN), 24 are types of dataset objects, 3 are collection objects, 5 are types of software objects, and 15 are 'other' (i.e. not defined elsewhere) for each of the various object classes. The different types and sources of object types are described below.

The large number of object types could make their use, for instance in filtering / selecting, difficult - users do not normally want to scroll through over a 100 options. The types are therefore allocated to different 'filter groups'. It is these groups that would be displayed in the interface, e.g. in a filter selection box. The 'filter as' column below indicates the filter group that would include any particular type. A detailed description of the filter groups is provided on the Object Filter Types page.

CASRAI text types

A suggestion in DataCite for Text objects is to use the CASRAI (Consortia Advancing Standards in Research Administration Information) output type list to provide the types (available at https://dictionary.casrai.org/Output_Types) and this suggestion is followed in the MDR, with all 35 CASRAI categories being used in the system as part of the 64 text types. They are listed below, with the details being taken directly from the CASRAI web site (the ids are from the ECRIN system).

id name description filter as use_in_data_entry source
12 Journal article Articles in peer-reviewed publications that disseminate the results of original research and scholarship. Journal article true CASRAI
101 Book Books written by a single author or collaboratively based on research or scholarly findings generally derived from peer reviewed funding. Book or chapter false CASRAI
102 Book chapter Texts written by a single author or collaboratively based on research or scholarly findings and expertise in a field. Book or chapter false CASRAI
103 Book prospectus Document that describes a forthcoming book based on research or scholarly findings. Book or chapter false CASRAI
104 Book review Critical review of works of fiction or non-fiction highlighting the contributions to an art, field or discipline. Book or chapter false CASRAI
105 Book series Set of related books written by a single author or collaboratively based on research or scholarly findings. Book or chapter false CASRAI
106 Conference abstract Texts of a specified length that states the issue to be discussed in a proposed conference paper. It serves as the basis for the acceptance of the paper at a conference. The abstract is published along with the paper. Conference material true CASRAI
107 Conference paper Papers written alone or collaboratively, presented at an academic conference, and published in the proceedings (not in scholarly journals). Conference material true CASRAI
108 Conference poster Posters displayed in a conference setting and conveying research highlights in an efficient manner by compelling graphics. They may be peer-reviewed prior to acceptance and be published in the proceedings. Conference material true CASRAI
109 Conference program Document giving details of papers to be presented at an academic conference, compiled from the accepted submissions. Conference material false CASRAI
110 Dictionary entry Entries of new words, new meanings of existing words, changes in spelling and hyphenation over a longer period of time, and grammatical changes. Other false CASRAI
111 Disclosure Publications that establish inventions as prior art thereby preventing others from patenting the same invention or concept. Other false CASRAI
112 Dissertation Treatise advancing an original point of view resulting from research: a requirement for a doctoral degree. Other information resource false CASRAI
113 Edited book Books edited by a single author or collaboratively for the dissemination of research or scholarly findings that generally result from peer reviewed funding. Book or chapter false CASRAI
114 Encyclopaedia entry Authored entries in a reference work or a compendium focusing on a particular domain or on all branches of knowledge. Other false CASRAI
115 Funding submission Information about specific requests for funds submitted to potential funders of the activity. The standard allows details to be collected for multiple years. Other false CASRAI
117 Journal issue Periodical publications aimed at fostering intellectual debate and inquiry. Special journal issues are produced by editors with an established record of scholarship in the field and able to provide the direction of the theme. Journal issues bear a unique number of reference for publication. Journal article false CASRAI
118 License Signed agreements to exploit a piece of IP such as a process, product, data, or software. Other false CASRAI
119 Magazine article Articles in thematic publications published at fixed intervals. Other article false CASRAI
120 Manual Course and assignment materials produced for teaching purposes. Other information resource false CASRAI
121 Newsletter article Articles in publications aimed at researchers, decision-makers, professionals and the public that report on a research project or on the activities of a research chair or a research centre. The Newsletters promote research activities to the community and the university; mobilize knowledge to improve practice and inform policy, and provide relevant and accessible information to the broader public. Other article false CASRAI
122 Newspaper article Articles in a daily, weekly or monthly publication reporting on news and social issues aimed at the public. May entail critical analysis based on expertise in the field. Other article false CASRAI
123 Online resource Information accessible only on the web via traditional technical methods (i.e. hyperlinks). Other information resource false CASRAI
124 Patent A form of IP protection that defines the exclusive right by law for inventors and assignees to make use of and exploit their inventions, products or processes, for a limited period of time. Other false CASRAI
125 Registered copyright Registered ownership of rights under a system of laws for promoting both the creation of and access to artistic, literary, musical, dramatic and other creative works. Other false CASRAI
126 Report Reports disseminating the outcomes and deliverables of a research contract. May entail a contribution to public policy. Other information resource false CASRAI
127 Research tool Series of observations, measurements or facts identified from the research. They include bibliographies, indices and catalogues of research collections; concordances and dictionaries; materials that facilitate access to archival holdings or collections such as repository guides, inventories of a group of manuscripts or of a body of archives, inventories or documentary materials, thematic guides to archival materials, records surveys and special indices; scholarly editions; and data series. Other information resource false CASRAI
128 Supervised student publication Articles on research findings published jointly with or supervised by the thesis advisor. The findings relate to research undertaken by the student or the supervisor’s program of research. Other information resource false CASRAI
129 Tenure-promotion A process of confidential deliberations by a committee, held in-camera, to decide tenure or promotion of an academic. Other false CASRAI
130 Test Assessments that include tests designed for general university selection, selection into specific courses or other evaluation purposes. Other false CASRAI
131 Trademark Marks such as a name, word, phrase, logo, symbol, design, image of a product or service that indicates the source and provides the right to control the use of the identifier. Other false CASRAI
132 Translation Translations of books and articles that identify modifications to the original edition, such as a new or revised preface. Other false CASRAI
133 University academic unit A primary academic organizational entity of a university that has appointed faculty. Other false CASRAI
134 Website Stand-alone locations on the web where multiple types of information on a specific theme are available. May include interactive features for contributions from readers. Website false CASRAI
135 Working paper / pre-print Preliminary versions of articles that have not undergone review but that may be shared for comment. Journal article true CASRAI

‘Journal Article’ is by far the most common type of text class data object. It is applied to all journal articles including those that are only published electronically – these are still text, even if the medium is different from traditional paper.

ECRIN text types

17 additional ECRIN defined text types were added initially, all focused on clinical research. As the processing of data sources developed, it became clear that there was a requirement for additional types. This has been the case with both BIOLINCC and ClinicalTrials.gov data, where a wide variety of study associated documents are found. This led to the inclusion of a further 18 text object types, for the most part specific to clinical research. Because these categories were added by ECRIN to accommodate BioLINCC or ClinicalTrials.gov data, their ‘source’ is identified as ‘ECRIN (BioLINCC)’ or ‘ECRIN (ClinicalTrials.gov)’.

id name description filter as use_in_data_entry source
11 Study protocol Structured document describing the study, its rationale, methodology, outcome measures etc. Study protocol true ECRIN
100 Journal article abstract A journal citation and abstract, usually on-line as a web page, e.g. within PubMed. Journal article false ECRIN
13 Trial registry entry Summary of the study and its aims, posted prospectively or retrospectively to a public registry. Trial registry entry false ECRIN
38 Study overview A brief overview of the study, may be an abridged protocol, or as used within the study web site or other study documents. Study overview true ECRIN (BioLINCC)
14 Ethics submission Documents provided to an ethics review board, often with the protocol, when seeking ethical approval for a study. Other study resource true ECRIN
15 Ethics approval notification Documents from an ethical review board confirming that ethical approval has been granted. Other study resource true ECRIN
16 Regulatory authority submission Documents provided to a regulatory authority, seeking approval to run a clinical trial. Other study resource true ECRIN
17 Regulatory authority approval notification Documents from a regulatory authority confirming that approval to run the trial has been granted. Other study resource true ECRIN
35 Manual of operations Description of specific operations and workflow within the study. Manual of procedures true ECRIN (BioLINCC)
36 Manual of procedures Description of specific procedures and techniques used within the study. Manual of procedures true ECRIN (BioLINCC)
18 Informed consent forms The form or forms given to participants to formally record their informed consent to study participation. Patient consent / information forms true ECRIN
19 Patient information sheets The information provided to study participants, especially as part of the consenting process. Patient consent / information forms true ECRIN
32 Data overview A summary of the data, without the details of a data dictionary but indicating the nature of different tables, time points of data etc. Data description true ECRIN (BioLINCC)
20 Database specification Functional specification of the database including details of individual data items, types, ranges, etc. May also contain details of logic and consistency checks, and any derived values. Data description true ECRIN
31 Data dictionary A detailed, item by item, description of the data points in the dataset, sufficient for accurate analysis of the data by others. Data description true ECRIN (BioLINCC)
21 Data collection forms Copies, in electronic and / or paper form, of the case report forms (CRFs and / or eCRFs) used for collecting data. Data collection forms true ECRIN
30 Annotated data collection forms Data Collection forms (CRFs or eCRFs) annotated to provide further details of each item (e.g. data type, allowable range). Data collection forms true ECRIN (BioLINCC)
40 Standard instruments Standardised rating instruments, including questionnaires. Data collection forms true ECRIN (BioLINCC)
22 Statistical analysis plan The details of the proposed analysis for the study, listing the individual descriptive statistics and tests of inference, and their parameters. Statistical analysis plan true ECRIN
29 Analysis notes A summary of the analysis carried out and / or any caveats to be borne in mind when interpreting results. Less formal than a statistical analysis plan. Statistical analysis plan true ECRIN (BioLINCC)
74 Protocol SAP Study Protocol and Statistical Analysis Plan, combined in one document. Study protocol true ECRIN (ClinicalTrials.gov)
75 Protocol ICF Study Protocol and Informed Consent Form, combined in one document. Study protocol true ECRIN (ClinicalTrials.gov)
76 Protocol SAP ICF Study Protocol, Statistical Analysis Plan, and Informed Consent Form, all combined in one document. Study protocol true ECRIN (ClinicalTrials.gov)
23 Data management plan A plan for, and record of, data management activities in the study, covering the whole data life cycle. Other study resource true ECRIN
33 Definitions A glossary list for use with other study documents. Other study resource true ECRIN (BioLINCC)
24 Trial master file contents list A listing of the documents expected within a trial master file, and their organisation, in electronic and / or paper form. Other study resource false ECRIN
81 Data collection schedule A document detailing the time points of data collection in a study (or 'visits'). Data description true ECRIN (BioLINCC)
82 Data coding manual A manual or guide that provides instructions on how to complete and / or interpret scores and codes within a study. Data description true ECRIN (BioLINCC)
25 Data monitoring committee report A report concerning the safety or efficacy of a study, from independent experts. Often containing recommendations about the continuation of the study. Other study resource false ECRIN
83 Bibliography A list of publications making up a bibliography relevant to the study, but not necessarily generated or triggered by the study. Other study resource false ECRIN (BioLINCC)
84 Introduction to document set A 'contents', 'readme' or similar document that describes the other documents available. Other study resource true ECRIN (BioLINCC)
85 Unpublished study report A report of a study, or part of a study, not formally published. May be an internal interim document within a long term study. Clinical study report true ECRIN (BioLINCC)
26 Clinical study report Full end of study report with detailed efficacy and safety results. Clinical study report true ECRIN
86 List of web links A web page that includes a list of links to different items, e.g. individual CRFs. Other study resource false ECRIN (BioLINCC)
79 CSR summary Summary of the Clinical Study Report. Clinical study report true ECRIN (ClinicalTrials.gov)
27 Redacted clinical study report End of study report with some data withheld, usually because of commercial sensitivity. Clinical study report true ECRIN
28 Trial registry results summary Summary of study results, as displayed in a trial registry. Registry results summary false ECRIN
34 Literature review Publications referenced within the literature review undertaken prior to the study. Other study resource false ECRIN (BioLINCC)
39 Publication list List of publications related to the study. Other study resource true ECRIN (BioLINCC)
77 Investigational product information Summary of information about a medicinal product. May be a package insert or investigator's brochure. Other study resource true ECRIN (ClinicalTrials.gov)
78 General background paper Supporting document summarising relevant research and / or research programs, or aspects of condition pathology, epidemiology, etc. Other study resource true ECRIN (ClinicalTrials.gov)
42 Redacted protocol A redacted version of the study protocol. Study protocol false ECRIN (ClinicalTrials.gov)
43 Redacted SAP A redacted version of the statistical analysis plan. Statistical analysis plan false ECRIN (ClinicalTrials.gov)

ECRIN dataset Types

In addition, there were 23 clinical research specific dataset objects defined by ECRIN, listed below (IPD = Individual Participant Data).

id name description filter as use_in_data_entry source
80 Individual participant data A dataset simply called Individual Participant Data, or its equivalent, with no further qualification or description. Individual participant data true ECRIN (ClinicalTrials.gov)
51 IPD final analysis dataset (full study population) Full final dataset supporting all analyses carried out on the study data. Individual participant data true ECRIN
52 IPD final analysis dataset (supporting specific paper) Dataset supporting the analyses and conclusions of a specific single paper. Individual participant data true ECRIN
53 IPD final analysis dataset (sub-population) Dataset with the data from a sub-population of the complete study (e.g. the control arm, or a particular age group). Individual participant data true ECRIN
54 IPD final analysis dataset (sub-study) Dataset with the data of a sub-study, supporting the analysis only of that sub-study - may also involve a sub-population of the whole. Individual participant data true ECRIN
56 IPD interim analysis dataset (sub-population) Dataset with the data from a sub-population of the complete study, from an earlier time point than the primary analysis. Individual participant data false ECRIN
57 IPD interim analysis dataset (sub-study) Dataset with the data of a sub-study, supporting the analysis only of that sub-study, from an earlier time point than the primary analysis. Individual participant data false ECRIN
58 IPD long term follow up analysis dataset Supplementary dataset with additional data from long term follow up, data collected after primary analysis. Individual participant data false ECRIN
55 IPD interim analysis dataset Dataset covering the whole study but from an earlier time point than the primary analysis. Individual participant data false ECRIN
59 IPD safety analysis dataset Dataset of individual data supporting comprehensive safety analysis. Individual participant data false ECRIN
60 IPD PK analysis dataset Dataset of pharmaco-kinetic data. Individual participant data false ECRIN
61 IPD PD analysis dataset Dataset of pharmaco-dynamic data. Individual participant data false ECRIN
62 IPD quality of life analysis dataset Dataset supporting analysis of quality of life measures within the study. Individual participant data false ECRIN
63 IPD analysis dataset, other Analysis dataset not listed in other options. Individual participant data false ECRIN
64 IPD analysis dataset metadata definition A dataset that is the metadata for an analysis dataset. Individual participant data true ECRIN
65 IPD CDMS format dataset A dataset in the format used by the data collection system (CDMS). May be a database file. Individual participant data false ECRIN
66 IPD CDMS format dataset metadata definition The metadata definition for the study's data collection system - equivalent to the functional specification of the system but as a dataset rather than a document. Individual participant data false ECRIN
67 IPD transport format dataset A dataset in a format designed specifically for transfer between systems. Individual participant data true ECRIN
68 IPD transport format dataset metadata definition Metadata describing the dataset when in a transport format. Individual participant data true ECRIN
69 Aggregated result dataset Dataset with aggregated / summary results and statistics from the study. Aggregated data true ECRIN
70 Aggregated result dataset, efficacy measures Dataset with aggregated results and statistics focusing on efficacy measures. Aggregated data false ECRIN
71 Aggregated result dataset, safety measures Dataset with aggregated results and statistics focusing on safety measures. Aggregated data false ECRIN
72 Aggregated result dataset, other Dataset with aggregated results and statistics, not listed elsewhere. Aggregated data false ECRIN
73 Aggregated result dataset metadata definition Metadata definition of an aggregated result set. Aggregated data true ECRIN

Collection types

The collection types defined so far are:

id name description filter as use_in_data_entry source
152 Grouped journal articles A collection of journal articles on the same topic or study (should also be recorded separately). Journal article false ECRIN
153 Grouped analysis datasets A collection of analysis datasets on the same topic or study (should also be recorded separately). Individual participant data false ECRIN
154 Grouped aggregated result datasets A collection of aggregated result datasets on the same topic or study (should also be recorded separately). Aggregated data false ECRIN

Software types

Whilst the 5 software types currently defined are:

id name description filter as use_in_data_entry source
166 Script(s) used in analysis Statistical software scripts used in study analysis. Software true ECRIN
167 CDMS Clinical Database Management System, or component within such a system, as used for clinical data management Software false ECRIN
168 Trial management system System used to support study administration. Software false ECRIN
169 eTMF Electronic trial management system. Software false ECRIN
170 Data extraction system Used for extracting data from remote resources using XML or web scraping. Software false ECRIN

'Other' types

14 records provide a single ‘other’ type, one for each object class. This is necessary because a type must belong to a specific class – a generic ‘other’ is not possible. If additional specific types are required for the text, dataset and software classes they should generally be created rather than subsumed under the ‘other’ type, but ‘other’ can be useful as a home for relatively rare types of object or those that are difficult to classify. There is also a single ‘unknown’ (type and class) entry, to avoid possible referential integrity issues at entity creation. All of these types are filtered as 'Other'.