Object types

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.

In usage (for instance if searching for a particular type of data object) the expectation is that a preliminary selection will be made on the object class. The user interface would then be able to show all types that ‘belonged’ to that class, e.g. in a second drop down box, for the user to further refine their search.

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	source
12	Journal Article	Articles in peer-reviewed publications that disseminate the results of original research and scholarship.	filter as	CASRAI
101	Book	Books written by a single author or collaboratively based on research or scholarly findings generally derived from peer reviewed funding.	filter as	CASRAI
102	Book Chapter	Texts written by a single author or collaboratively based on research or scholarly findings and expertise in a field.	filter as	CASRAI
103	Book Prospectus	Document that describes a forthcoming book based on research or scholarly findings.	filter as	CASRAI
104	Book Review	Critical review of works of fiction or non-fiction highlighting the contributions to an art, field or discipline.	filter as	CASRAI
105	Book Series	Set of related books written by a single author or collaboratively based on research or scholarly findings.	filter as	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.	filter as	CASRAI
107	Conference Paper	Papers written alone or collaboratively, presented at an academic conference, and published in the proceedings (not in scholarly journals).	filter as	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.	filter as	CASRAI
109	Conference Program	Document giving details of papers to be presented at an academic conference, compiled from the accepted submissions.	filter as	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.	filter as	CASRAI
111	Disclosure	Publications that establish inventions as prior art thereby preventing others from patenting the same invention or concept.	filter as	CASRAI
112	Dissertation	Treatise advancing an original point of view resulting from research: a requirement for a doctoral degree.	filter as	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.	filter as	CASRAI
114	Encyclopaedia Entry	Authored entries in a reference work or a compendium focusing on a particular domain or on all branches of knowledge.	filter as	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.	filter as	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.	filter as	CASRAI
118	License	Signed agreements to exploit a piece of IP such as a process, product, data, or software.	filter as	CASRAI
119	Magazine Article	Articles in thematic publications published at fixed intervals.	filter as	CASRAI
120	Manual	Course and assignment materials produced for teaching purposes.	filter as	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.	filter as	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.	filter as	CASRAI
123	Online Resource	Information accessible only on the web via traditional technical methods (i.e. hyperlinks).	filter as	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.	filter as	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.	filter as	CASRAI
126	Report	Reports disseminating the outcomes and deliverables of a research contract. May entail a contribution to public policy.	filter as	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.	filter as	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.	filter as	CASRAI
129	Tenure-Promotion	A process of confidential deliberations by a committee, held in-camera, to decide tenure or promotion of an academic.	filter as	CASRAI
130	Test	Assessments that include tests designed for general university selection, selection into specific courses or other evaluation purposes.	filter as	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.	filter as	CASRAI
132	Translation	Translations of books and articles that identify modifications to the original edition, such as a new or revised preface.	filter as	CASRAI
133	University Academic Unit	A primary academic organizational entity of a university that has appointed faculty.	filter as	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.	filter as	CASRAI
135	Working Paper	Preliminary versions of articles that have not undergone review but that may be shared for comment.	filter as	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	source
11	Study Protocol	Structured document describing the study, its rationale, methodology, outcome measures etc.	ECRIN
100	Journal article abstract	A journal citation and abstract, usually on-line as a web page, e.g. within PubMed.	ECRIN
13	Trial Registry entry	Summary of the study and its aims, posted prospectively or retrospectively to a public registry.	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.	ECRIN (BioLINCC)
14	Ethics submission	Documents provided to an ethics review board, often with the protocol, when seeking ethical approval for a study.	ECRIN
15	Ethics approval notification	Documents from an ethical review board confirming that ethical approval has been granted.	ECRIN
16	Regulatory authority submission	Documents provided to a regulatory authority, seeking approval to run a clinical trial.	ECRIN
17	Regulatory authority approval notification	Documents from a regulatory authority confirming that approval to run the trial has been granted.	ECRIN
35	Manual of Operations	Description of specific operations and workflow within the study.	ECRIN (BioLINCC)
36	Manual of Procedures	Description of specific procedures and techniques used within the study.	ECRIN (BioLINCC)
18	Informed consent forms	The form or forms given to participants to formally record their informed consent to study participation.	ECRIN
19	Patient information sheets	The information provided to study participants, especially as part of the consenting process.	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.	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.	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.	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.	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).	ECRIN (BioLINCC)
40	Standard instruments	Standardised rating instruments, including questionnaires.	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.	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.	ECRIN (BioLINCC)
74	Protocol SAP	Study Protocol and Statistical Analysis Plan, combined in one document.	ECRIN (ClinicalTrials.gov)
75	Protocol ICF	Study Protocol and Informed Consent Form, combined in one document.	ECRIN (ClinicalTrials.gov)
76	Protocol SAP ICF	Study Protocol, Statistical Analysis Plan, and Informed Consent Form, all combined in one document.	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.	ECRIN
33	Definitions	A glossary list for use with other study documents.	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.	ECRIN
81	Data collection schedule	A document detailing the time points of data collection in a study (or 'visits').	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.	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.	ECRIN
83	Bibliography	A list of publications making up a bibliography relevant to the study, but not necessarily generated or triggered by the study.	ECRIN (BioLINCC)
84	Introduction to document set	A 'contents', 'readme' or similar document that describes the other documents available.	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.	ECRIN (BioLINCC)
26	Clinical Study Report	Full end of study report with detailed efficacy and safety results.	ECRIN
86	List of web links	A web page that includes a list of links to different items, e.g. individual CRFs.	ECRIN (BioLINCC)
79	CSR Summary	Summary of the Clinical Study Report.	ECRIN (ClinicalTrials.gov)
27	Redacted Clinical Study Report	End of study report with some data withheld, usually because of commercial sensitivity.	ECRIN
28	Trial registry results summary	Summary of study results, as displayed in a trial registry.	ECRIN
34	Literature Review	Publications referenced within the literature review undertaken prior to the study.	ECRIN (BioLINCC)
39	Publication List	List of publications related to the study.	ECRIN (BioLINCC)
77	Investigational Product Information	Summary of information about a medicinal product. May be a package insert or investigator's brochure.	ECRIN (ClinicalTrials.gov)
78	General background to research topic	Supporting document summarising relevant research and / or research programs, or aspects of condition pathology, epidemiology, etc.	ECRIN (ClinicalTrials.gov)
42	Redacted Protocol	A redacted version of the study protocol.	ECRIN (ClinicalTrials.gov)
43	Redacted SAP	A redacted version of the statistical analysis plan.	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	source
80	Individual Participant Data	A dataset simply called Individual Participant Data, or its equivalent, with no further qualification or description.	ECRIN (ClinicalTrials.gov)
51	IPD final analysis dataset (full study population)	Full final dataset supporting all analyses carried out on the study data.	ECRIN
52	IPD final analysis dataset (supporting specific paper)	Dataset supporting the analyses and conclusions of a specific single paper.	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).	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.	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.	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.	ECRIN
58	IPD long term follow up analysis dataset	Supplementary dataset with additional data from long term follow up, data collected after primary analysis.	ECRIN
55	IPD interim analysis dataset	Dataset covering the whole study but from an earlier time point than the primary analysis.	ECRIN
59	IPD safety analysis dataset	Dataset of individual data supporting comprehensive safety analysis.	ECRIN
60	IPD PK analysis dataset	Dataset of pharmaco-kinetic data.	ECRIN
61	IPD PD analysis dataset	Dataset of pharmaco-dynamic data.	ECRIN
62	IPD quality of life analysis dataset	Dataset supporting analysis of quality of life measures within the study.	ECRIN
63	IPD analysis dataset, other	Analysis dataset not listed in other options.	ECRIN
64	IPD analysis dataset metadata definition	A dataset that is the metadata for an analysis dataset.	ECRIN
65	IPD CDMS format dataset	A dataset in the format used by the data collection system (CDMS). May be a database file.	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.	ECRIN
67	IPD transport format dataset	A dataset in a format designed specifically for transfer between systems.	ECRIN
68	IPD transport format dataset metadata definition	Metadata describing the dataset when in a transport format.	ECRIN
69	Aggregated result dataset	Dataset with aggregated / summary results and statistics from the study.	ECRIN
70	Aggregated result dataset, efficacy measures	Dataset with aggregated results and statistics focusing on efficacy measures.	ECRIN
71	Aggregated result dataset, safety measures	Dataset with aggregated results and statistics focusing on safety measures.	ECRIN
72	Aggregated result dataset, other	Dataset with aggregated results and statistics, not listed elsewhere.	ECRIN
73	Aggregated result dataset metadata definition	Metadata definition of an aggregated result set.	ECRIN

Collection types

The collection types defined so far are:

id	name	description	source
152	Grouped journal articles	A collection of journal articles on the same topic or study (should also be recorded separately).	ECRIN
153	Grouped analysis datasets	A collection of analysis datasets on the same topic or study (should also be recorded separately).	ECRIN
154	Grouped aggregated result datasets	A collection of aggregated result datasets on the same topic or study (should also be recorded separately).	ECRIN

Software types

Whilst the 5 software types currently defined are:

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