PhUse Emerging Technology Working Group Metadata definitions

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Project:

Metadata Management


Title:


Metadata Definitions

Working Group:
Emerging Te
chnologies

Version: 0.
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Date:
17
th

May 2013




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PhUse

Emerging Technology Working Group

Meta
data definitions





Project:

Metadata Management


Title:


Metadata Definitions

Working Group:
Emerging Te
chnologies

Version: 0.
2

Date:
17
th

May 2013




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Table of Contents

1

INTRODUCTION: PURPOS
E OF THIS DOCUMENT

................................
................................
....

4

2

SCOPE

................................
................................
................................
................................
............

4

3

DEFINITIONS

................................
................................
................................
................................
..

4

3.1

METADATA MANAGEMENT

................................
................................
................................
....

4

3.1.1

Metadata

................................
................................
................................
......................

4

3.1.1

Structural metadata

................................
................................
................................
......

5

3.1.2

Descriptive metadata

................................
................................
................................
...

6

3.1.3

Process metadata

................................
................................
................................
........

7

3.1.4

Structural metadata: standards metadata

................................
................................
....

8

3.1.5

Study
-
Instance Metadata or Study specific metadata

................................
.................

8

3.1.6

Semantic Metadata

................................
................................
................................
......

9

3.1.1

Metadata repository

................................
................................
................................
.....

9

3.1.2

Metadata registry

................................
................................
................................
.......

10

3.1.3

Data element

................................
................................
................................
..............

10

3.1.4

Attribute

................................
................................
................................
......................

11

3.1.5

Class

................................
................................
................................
..........................

11

3.1.6

Data type

................................
................................
................................
....................

11

3.2

MASTER DATA MANAGEME
NT

................................
................................
............................

11

3.2.1

Master Data

................................
................................
................................
................

11

3.2.2

Master Data Management

................................
................................
.........................

12

3.2.3

Master Reference Data

................................
................................
..............................

12

3.2.4

Master Data Source System

................................
................................
......................

12

3.2.5

Reference Data

................................
................................
................................
..........

12

3.2.6

Reference Data Management

................................
................................
....................

13

3.3

CONTROLLED TERMINOLO
GY, CODE SYSTEMS & V
ALUE SETS

................................
..

13

3.3.1

Concept

................................
................................
................................
......................

13

3.3.2

Code

................................
................................
................................
...........................

13

3.3.3

Code system

................................
................................
................................
..............

13

3.3.4

Concept definition

................................
................................
................................
......

13

3.3.5

Concept designation

................................
................................
................................
..

13

3.3.6

Concept domain

................................
................................
................................
.........

13

3.3.7

Concept identifier

................................
................................
................................
.......

13

3.3.8

Concept representation

................................
................................
..............................

13

3.3.9

Value set

................................
................................
................................
....................

13

3.4

INTEROPERABILITY

................................
................................
................................
..............

13

3.4.1

Interoperability

................................
................................
................................
............

13

3.4.2

Technical interoperability (“machine interoperability”)

................................
..............

14

3.4.3

Semantic interoperability

................................
................................
............................

14

3.4.4

Process Interoperability

................................
................................
.............................

15

3.5

DATA AGGREGATION, IN
TEGRATI
ON

................................
................................
................

15

3.5.1

Data pooling

................................
................................
................................
...............

15


Project:

Metadata Management


Title:


Metadata Definitions

Working Group:
Emerging Te
chnologies

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3.5.2

Data aggregation

................................
................................
................................
........

16

3.5.3

Data integration

................................
................................
................................
..........

16

4

INPUT (DRAFT MATERIA
L THAT CAN BE USED


TO BE DELETED IN FIN
AL DOCUMENT)
17

4.1

METADATA MANAGEMENT

................................
................................
................................
..

17

4.2

MASTER DATA MANAGEME
NT

................................
................................
............................

18

4.3

CONTROLLED TERMINOLO
GY

................................
................................
............................

19

4.4

INTEROPERABILITY

................................
................................
................................
..............

21

4.5

DATA AGGREGATION

................................
................................
................................
...........

22

5

REFERENCES & RELATED

DOCUMENTS

................................
................................
................

23

6

APPENDICES

................................
................................
................................
...............................

23

6.1

CDISC GLOSSARY

................................
................................
................................
................

23



Project:

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Title:


Metadata Definitions

Working Group:
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1

INTRODUCTION
: purpose of this document

This document provides
agreed
definitions around meta
-
data management and related aspects across
the industry.
I
t is expected that these definitions will be re
-
used in the FDA guidelines as ag
reed cross
industry definitions.

To be of
operational value
, the document contains not only d
efinitio
ns but also a short description

and
example of use.
Whenever possible, t
he definitions
are built

from those existing definitions from FDA
guidance's, CDISC glossary, check cross ind
ustry definition (e.g. Gartner)
.

Reference to the source
definition

is provided.

This document does not intend to be extensive and complete. It is intended to bring clarification on the
most commonly used (and mi
s
used !) definition in our industry around metadata and master data
management;


The CDISC glossary
[CDISC1]

(
and document in attachment) is heavily used as reference in this document;
It is expected that the reader of this document is familiar with the abbreviations and
Synonym
s
contained in the CDISC glossary; these are not repeated here.

2

SCOPE

The following
topic areas are in scope of this document



Meta
data
management: metadata
(structural & operational), data elements, attributes
, classes..



Master data management:
Master data
, reference data,
master reference data



Controlled terminology, code systems, value
sets, permissible values



Data pooling, data integration, data aggregation



Interoperability, semantic interoperability


Definitions are

provided
per topic area to ease reading and structure of this document.


3

DEFINITIONS

3.1

Metadata management

3.1.1

Metadata

Synonym


Definition

&
source



Wikipedia
.
The term metadata refers to "
data

about data". The term is ambiguous,
as it is used for two fundamentally different concepts (
types
).

o

Structural metadata

is about the design and specification of data
structures and is more properly called "data about the containers of data";

o

Descriptive metadata
, on the ot
her hand, is about individual instances of
application data, the data content. In this case, a useful description



ISO 11179.

“D
escriptive data ab
out an object [ISO/IEC 20944
-
1]”
. Thus, metadata
is a kind of data.


Project:

Metadata Management


Title:


Metadata Definitions

Working Group:
Emerging Te
chnologies

Version: 0.
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Date:
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May 2013




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Adrienne Tannenbaum, Metadata Solutions
:
"Metadata: the detailed description
of the instance data; the format and characteristics of populated instance data;
instances and values depending on the role of the metadata recipient." and
"Instance data: That which is input into a receiving tool, appli
cation, database, or
simple processing engine".

Description

Metadata describe instance data
. Instance data are data stored in a computer as the
result of data entry by a person or data processing by an application.

A metadata can become an instance data described itself by a level 2 metadata (or
meta metadata) As an
example Marcelina ??

There are
2

types of metadata (see below for more details description

and examples
)



Structural metadata



Descriptive metadata




Examp
le

See structural metadata

and
descriptive

metadata

Recommended

definition



3.1.1

Structural

metadata

Synonym

Standard metadata

Data Standard

Definition & source



http://en.wikipedia.org/wiki/Metadata


The design and specification of data structures (e.g. format, semantic, ..),
cannot be “data about data”, because at design time the application
contains no data. In this case the correct description would be
"data/information about the containers of data"
.



[
FDA1]

Structural metadata is structured information that describes, explains, or
otherwise makes it easier to retrieve, use, or manage data.



Octagon.
St
andards
metadata is the metadata that is defined, maintained,
and governed as the standard descripti
on of the data that will facilitate
clinical software re
-
use and thus process efficiency. It is metadata that
describes the standard, not a study built per the standard. Both industry
standards such as CDISC and sponsor
-
defined standards are commonly
tho
ught of standards metadata.


Description

Structural metadata is what most of people mean by metadata. Structural
metadata

is said to “give meaning to data” or to put data “in context.”

Structural metadata, or standards metadata, is the source from which the
Study specific metadata (see below) is built. Key components of standards
metadata often include data domains, data elements, terminology, data
mappings and transformations, and data

derivations.


Project:

Metadata Management


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Metadata Definitions

Working Group:
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chnologies

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The successful usage of standards metadata requires sufficient standards
governance that should include:



workflows to address the creation of and/or revision of the standards



version control of standards metadata and study specific metadata



access control to the metadata, by user role


Example

The number
120
itself is meaningless without
structural metadata such as



The name of the variable (e.g.
Systolic Blood Pressure
) with its definition



The unit related to this physical quantity (e.g;
Systolic Blood Pressure Unit

=
mmHG)


CDISC SDTM
is

the structural metadata


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For instance the variable “Sex” is described by a set of structural meta data
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female, ..), role in SDTM, …



The metadata for the AE (Adverse Event) SDTM domain that is compliant
with the CDISC SDTM Implementation Guide (Version 3.1.3) consists of
attributes such as Variable Name, Variable Label, Type, Controlled

Terms,
Role, etc.


A d
ata model
-

describing the
classes
, attributes,

relationships and hierarchies


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3.1.2

Descriptive

metadata

Synonym

Process metadata

Semantic
metadata

Definition &
source



http://en.wikipedia.org/wiki/Metadata


The individual instances of application data, the data content. In this case, a useful
description would be "data about data content"

or "content about content".



Ralph Kimball's

"Process metadata describes the results of various operations in a
data warehouse."



metadata that describes relevant or domain
-
specific informat
ion about content. It
provides
conceptual, contextual, and process
ing information for data elements. It
can also provide greater depth and more insight about the "container" of the data,
whether it is a file, document, or representation.

Description

It is used in different contexts



Data operations and statistical analy
sis
. Additional content on the data that

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support further analysis of the data. For instance patient population in the context
of a clinical trial study is operational metadata



Software implementation (process metadata)
:
describes the results of various
operations happening in an application, be it in a data warehouse or any other
application. This includes

o

processes used to reformat (convert) or transcode content.

o

all information needed to support data lineage & traceability

o

details of origin and usage
(including start and end times for creation,
updates and access).


Descriptive

metadata is often a key enabler in deriving business value from data
through both direct relationships and indirect relationships between data elements
. In
effect, it creates t
he “how”, “where”, “who”, and “when” for the data elements.




“How”
-

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“Where”
-

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“Who”
-

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“When”
-

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䕸慭ple



Study related metadata: patient population, indication, therapeutic area



Process

metadata:

o

metadata
needed

for the effective management of version c
ontrol for
standards metadata:
the UserID that executed the las
t modification, the
date

of the last modification, and the UserID who approved the last
modification.

o

What is the source of the data and in which system is it authored

o

Who can use a piece of information different roles for access and action
they can perform: who can edit it in wh
ich system, who has read access to
it

o

Which transformation happen to the data, how and when

o

Audit trail: who access which information, when


Recommended

definition



3.1.3

Process metadata

(
suggest to
combine

with descriptive metadata !!!!)


Synonym


Definition &
source



Ralph Kimball's

"Process metadata describes the results of various operations in a
data warehouse."

Description

Process metadata describes the results of various operations
happening in an
application, be it
in a data warehouse

or any other application. This includes


Project:

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chnologies

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May 2013




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processes used to reformat (convert) or transcode content.



all information needed to support data lineage & traceability



details of origin and usage (including start and end times for creation, updates and
access).

Example



What is the source of the data and in which system is it authored



Who can use a piece of information different roles for access and action they can
perform: who can edit it in which system, who has read access to it



Which transformation happen to

the data, how and when



Audit trail: who access which information, when



Version control

Recommended
definition



3.1.4

Structural metadata: standards metadata

Synonym

OUT


included in structural metadata

Definition & source


Description


Example


Recommended definition



3.1.5

Study
-
Instance Metadata

or Study specific metadata

Synonym

Study Data Standards

Study Specific Structural metadata

Definition & source

[
No source]



Study
-
Instance metadata is a defined
grouping of metadata that serves as
the most complete representation of the metadata that defines an
individual study.



It is commonly thought of as the set of metadata that is actually consumed
by the clinical
technology platform

to facilitate processes
that are more
automated and consistent.



It consists of
Structural
and Des
criptive

m
etadata

Description

Within the context of a Metadata
store
, Study
-
Instance Metadata is stored
separate
ly

from the Standards Metadata, either as a set of relationships back
to the Standards Metadata or as a copy of the Standards Metadata. This is
dependent on the Metadata
store

tool in use.

The Study
-
Instance Metadata (the most complete representation of the

metadata that defines an individual study) is exported to and consumed by the
clinical data
platform

to ensure maximal automation and consistency of the

Project:

Metadata Management


Title:


Metadata Definitions

Working Group:
Emerging Te
chnologies

Version: 0.
2

Date:
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th

May 2013




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processes for trial design, execution, storage, analysis, and submission.

Because the Study
-
Instance

Metadata can consist of Structural, Standards, and
Operational Metadata, there exists a wide range of purposes that can be
served as Study
-
Instance Metadata.



Trial
-
definition metadata per the PRM



Trial
-
definition metadata per SDTM Trial Design



Study CRF
s metadata



Data
-
definition metadata



Submission Define.xml

Example

During the set
-
up of a clinical trial collection database, the Oncology project
team decides to use the AECAT variable in anticipation of grouping the
multitude of adverse events at the tim
e of analysis. This project team has been
granted the option to select AECAT from a subset of the Permissible data
elements of the SDTM standard by the standards governance group for the
sponsor’s organization. This project choice is stored within the St
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3.1.6

Semantic Metadata

Synonym

OUT


included in descriptive

Definition & source


Description


Example


Recommended definition



3.1.1

Metadata repository

Synonym


Definition &
source


Description


Example


Recommended

definition




Project:

Metadata Management


Title:


Metadata Definitions

Working Group:
Emerging Te
chnologies

Version: 0.
2

Date:
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th

May 2013




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3.1.2

Metadata registry

Synonym


Definition &
source

ISO 11179 standard and this web page
http://datadictionary.blogspot.com/2008/03/metadata
-
repositories
-
vs
-
metadata.html, it seems the definition of "MDR" should be discussed. Is it a Metadata
Repository or Metadata Registry? The point that was interesting from that website
was a "Registry is

a protected back room where human
-
centric workflow processes are
used ensure that metadata items are non
-
duplicates, precise, consistent, concise,
distinct, approved and unencumbered with business rules that prevent reuse across an
enterprise". There is
quite a good point here.

Description


Example


Recommended

definition


3.1.3

Data

element

Synonym

DE

Definition

[
FDA1]

A data element is the smallest (or
atomic
) piece o
f information that is useful

for
analysis (e.g., a systolic blood pressure measurement, a lab t
est result, a response
to a
question on a questionnaire).


[
CDISC1]

1. For XML, an item of data provided in
a mark
-
up mode to allow machine
processing.
[FDA
-

GL/IEEE]

2. Smallest unit of i
nformation in a transaction.
[Center for Advancement of Clinical
Research]

3. A structured item characterized by a stem and response options together with a
history of usage that can be standardized for research purposes across studies
conducted by and for

NIH.
[NCI, caBIG]

NOTE: The mark up or tagging facilitates document indexing, search and retrieval,
and provides standard conventions for insertion of codes.


[
ISO1]

unit of data for which the definition, identification, representation and permissible
va
lues are specified by means of

a set of attributes

Description

A
Data Element
is the most elementary

unit of data that cannot be further subdivided
from a semantic point of view, as it is linked with a precise meaning.

A data element has:



An identification such as a data element name


Project:

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Metadata Definitions

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chnologies

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th

May 2013




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A clear d
efinition/ semantic description



A data type



Optional e
numerated values (value sets)



On
e or more representation terms

(synonyms)


Synonyms



In the context of SDTM a variable is equivalent to a Data Elem
ent



In the context of BRIDG, an attribute is equivalent to a Data Element

Example

Birth Date is a Data Element



DE name: BirthDate



Definition: date and time on which the subject is born



Data type: date (mm/dd/yyyy


UUImmIs猠


瑩m攠zone)



Value sets: not
applicable



Synonyms: BRTDTC in CDISC SDTM, birthdate in BRIDG

Recommended

definition



3.1.4

Attribute

3.1.5

Class

3.1.6

Data type




3.2

Master data management

3.2.1

Master Data

Synonym


Definition &
source

[
Gartner


Magic Quadrant for Master Data Management of Customer Data
Solution
]

http://www.gartner.com/technology/reprints.do?id=1
-
1CK9UDO&ct=121019&st=sb


Master data is the consistent and uniform set of identifiers and extended attri
butes
that describes the core entities of the enterprise, such as customers, prospects,
citizens, suppliers, sites, hierarchies and chart of accounts.

Description

Master Data is business data that has a co
nsistent meaning and definition
,
shared across
systems
.
It is produced into a “master system” as part of a transaction and is used for reference
and validation in transactions within other systems.



Master Data


as any other data


are defined with structural Meta data

Example



Site identification inf
ormation such as : Site ID, Site Name, Site Address, …



Investigator identification attributes


Project:

Metadata Management


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Metadata Definitions

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chnologies

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Study Identification attributes

Recommended

definition



3.2.2

Master Data Management

Synonym


Definition &
source

[
Gartner


Magic Quadrant for Master Data
Management of Customer Data Solution
]

http://www.gartner.com/technology/reprints.do?id=1
-
1CK9UDO&ct=121019&st=sb


MDM is a technology
-
enabled discipline in which bus
iness and IT work together to
ensure the uniformity, accuracy, stewardship, semantic consistency and accountability
of the enterprise's official, shared master data assets.


Description




Example

o


Recommended

definition



3.2.3

Master Reference Data

Synonym


Definition &
source


Description

A combination of Master Data and Reference Data. The governance of these 2 components is
quite different:



reference data are often defined by external organizations and are defined at design time
;
they are generally
managed within a terminology server (or a meta data repository) as part
of all the code systems



master data are created during application run time

through a transaction and are stored
into the source system considered as the source of truth.

Example




Recommended

definition



3.2.4

Master Data Source System

3.2.5

Reference Data

Synonym


Definition &
source


Description



In context of Master Reference Data Management this corresponds to the set of code
systems

that are commonly used across many different systems and attributes


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Example



List of Country codes



List of
Therapeutic areas

Recommended

definition



3.2.6

Reference Data Management



3.3

Controlled Terminology, code systems & value sets

3.3.1

Concept

Synonym


Definition &
source


Description


Example


Recommended

definition




3.3.2

Code

3.3.3

Code system

3.3.4

Concept definition

3.3.5

Concept designation

3.3.6

Concept domain

3.3.7

Concept identifier

3.3.8

Concept representation

3.3.9

Value set



3.4

Interoperability

3.4.1

Interoperability

Synonym


Definition &
source



ISO 11179

interoperability concerning the creation, meaning, computation, use,
transfer,

and exchange of data [ISO/IEC 20944
-
1]



ISO 1117:
capability to communicate, execute programs, or transfer data among

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various functional units in a manner that
requires the user to have little or no
knowledge of the unique characteristics of those units [ISO/IEC 2382
-
1]"



IEEE:
ability of two or more systems of components to exchange information and
to use the informatio
n that has been exchanged.




Description


Example


Recommended

definition



3.4.2

Technical interoperability

(“machine interoperability”)

Synonym


Definition &
source

Technical Interoperability: The focus of technical interoperability is on the conveyance
of data, not on its meaning. Technical interoperability encompasses the transmission
and reception of information that can be used by a person but which cannot be fur
ther
processed into semantic equivalents by software. Note that mathematical operations
can be
--

and frequently are
--

performed at the level of technical interoperability. A
good example is the use of a “check digit” to determine the integrity of a spec
ific unit
of transmitted or keyed
-
in data. The same mathematical formula is performed at each
end of a transaction and the results compared to assure that the data was successfully
transmitted.

Technical interoperability moves data from system A to sys
tem B.

Synonyms: Functional, Syntactic, exchange

Description


Example


Recommended

definition



3.4.3

Semantic interoperability

Synonym


Definition &
source

Semantic Ineroperability: To maximize the usefulness of shared information and to
apply
applications like intelligent decision support systems, a higher level of
interoperability is required. This is called semantic interoperability which has been
defined as the ability of information shared by systems to be understood… so that
non
-
numeric da
ta can be processed by the receiving system. Semantic interoperability
is a multi
-
level concept with the degree of semantic interoperability dependent on the
level of agreement on data content terminology and the content of archetypes and
templates used by

the sending and receiving systems.


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chnologies

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Semantic Interoperability ensures that system A and system B understand the data in
the same way

Description


Example


Recommended

definition




3.4.4

Process Interoperability

Synonym


Definition &
source

Process
Interoperability: Process interoperability is an emerging concept that has
been identified as a requirement for successful system implementation into actual
work settings. It was identified during the project by its inclusion in academic papers,
mainly fr
om Europe, and by its being highlighted by an Institute of Medicine (IOM)
report issued in July 2005 which identified this social or workflow engineering as key to
improving safety and quality in health care settings, and for improving benefits
realization
. It deals primarily with methods for the optimal integration of computer
systems into actual work settings and includes the following:

• Explicit user role specification

• Useful, friendly, and efficient human
-
machine interface

• Data presentation/flow s
upports work setting

• Engineered work design

• Explicit user role specification

• Proven effectiveness in actual use

Process interoperability coordinates work processes, enabling the business processes
at the organizations that house system A and system

B to work together. Process
interoperability is achieved when human beings share a common understanding, so
that business systems interoperate and work processes are coordinated.

Comment: EU Interoperability framework (EIF) defines organizational Interope
rability
which might be the same as process interoperability?

Description


Example


Recommended

definition



3.5

Data aggregation, integration

3.5.1

Data pooling

POOLING

is the act of pulling together different kinds of data on the same patient (or set of patients in a
clinical trial) to give a holistic representation of what was observed for each patient during the clinical
trial.


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Observed data are the foundation of the

clinical trial and should accurately reflect what
happened during the course of the trial to the patients in the trial.



Once a trial is completed and a database locked, the observed data should never change. It
becomes a historical record/fact of what
occurred during the trial.



Observed data is frequently manipulated to transfer it from one system to another or to
facilitate analysis and presentation of the data.



Transformations

are defined as data mappings to restructure the data format, but leave the

data itself unchanged. This often occurs since the format in which the data is collected will
depend on the source and the IT requirements for such data collection and storage. This is
largely a rules
-
based activity.



Derivations

are the use of mathematic
al or logical algorithms to change or to create new data
values or flags. Derivations also include imputations for missing data to facilitate statistical
analysis and inference.


3.5.2

Data aggregation

3.5.3

Data integration


INTEGRATION

is the storage of individual
datasets in a common physical or virtual IT system. The
individual datasets remain distinct entities, but have are located in the same IT
environment/infrastructure.


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4

INPUT (draft material that can be used


to be deleted in final document)


4.1

Metadata
management

Term

Synonym

Definition

attribute


Description of a property of an object. An attribute may be further described as a data element stored in a
metadata repository and in implementation, becomes one or more variables.

For example: in BRIDG,
raceCode

is an attribute of class Person (i.e. Person.raceCode), and
value

is an
attribute of DefinedObservationResult.

class


Set of Data Elements describing a logical “thing”

A class has:

• An identifier such as an class name

• A clear object
definition / semantic description

• One or more representation terms

• A list of DE (also known as attributes)

• A list of related classes and a description of the relationship type(s)• Any description


in addition to DE


that allow to map the object wit
h an application vertical

Data Type


A data type is a classification identifying one of various types of data, such as real
-
valued, integer or
Boolean, that determines the possible values for that type; the operations that can be done on values of
that ty
pe; the meaning of the data; and the way values of that type can be stored.

Metadata
Management

MEM

Metadata Management is a worldwide infrastructure composed of policies, procedures, standards, models,
skills, tools and training needed to promote the shareability of data throughout the enterprise and to our
customers.

Meta Data
Repository

MDR

Repository composed of Descriptive Meta Data.

Within the clinical research world, there is around 30.000 to 50.000 different data elements covering all
potential data that can be collected for a patient.




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4.2

Master data management

Term

Synonym

Definition

Master Data



Master Data is business data that has a consistent meaning and definition to ne shared across systems; this
applies particularly to data such as site identification, investigator identification, and study identification. It
is produced into
a “master system” as part of a transaction and is used for reference and validation in
transactions within other systems.

Master Data


as any other data


are defined with structural Meta data

Master Data
Management

MDM

Master Data Management comprises a

set of processes and tools that consistently defines and manages the
non
-
transactional data entities of an enterprise which is fundamental to the company’s business operations
(may include reference data). Master Data Management has the objective of provi
ding processes for
collecting, aggregating, matching, consolidating, quality
-
assuring, persisting and distributing such data
throughout the enterprise to ensure consistency and control in the ongoing maintenance and application
use of this data. This is so
metimes known as Reference Data Management.

Master
Reference
Data



A combination of Master Data and Reference Data. The governance of these 2 components is however quite
different:



reference data

are often defined by external organizations and are defined at design time; they are
generally managed within a terminology server (or a meta data repository) as part of all the code
systems



master data

are created during application run time through a tr
ansaction and are stored into the
source system considered as the source of truth.

Master Data
Source
System



Master Data Source System is the application that houses a master data “dimension” (or type of master data
such as site or investigator) for Pe
rceptive Informatics. The system is available to all applications
(operational and information provisioning, including the Data Warehouse) across the enterprise.

Reference
Data



In context of Master Reference Data Management this corresponds to the set
of code systems that are
commonly used across many different systems and attributes

Reference
Data
Management



Management of Reference Data


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4.3

Controlled terminology

Term

Synonym

Definition

Concept


A concept is a “unit of thought” within a particular domain


a unitary or atomic
mental representation of a
real or abstract thing

Concept
s, as abstract, language
-

and context
-
independent representations of meaning, are important for
the design and interp
retation of static information models. They constitute the smallest semantic entities
1

with which models are built. The authors and the readers of an information model use concepts and their
relationships to build and understand the models.

code


Code’
is the
machine
-
processable part of a
Concept Representation,

published by the author of a
code
system

as part of the
code system.

It is the preferred unique machine
-
readable identifier for that concept in that
code system

and is used in the
'code' property of an ISO 21090 CD data type.

Codes are sometimes meaningless identifiers, and sometimes they are mnemonics that imply the
represented concept to a human reader;
meaningless identifiers are advised particularly in larger

vocabulary
systems

Code system


A Code System is a managed collection of concept representations, including codes and/or designations

(or
human readable text/decode)
, but sometimes with more complex sets of rules, references (definitions), and
relationsh
ips.

Although things may be differentially referred to as terminologies, vocabularies, or coding schemes, or even
classifications, the ISO 21090 CD datatype considers all such collections ‘
code systems
’.

A code system is typically created for a particula
r purpose; they may consist of finite collections, such as
concepts that represent individual countries, colours, or states, or they may represent broad and complex
collections of concepts across a particular domain, e.g., SNOMED
-
CT, ICD, LOINC, and CPT. A

code system
should be uniquely identifiable; for ISO 21090conformant uses, this identifier shall take the form of an ISO
OID.




1

As models are layered and developed, the size and
description of the smallest semantic entity may change, to best meet the use case(s) and requirements, and to
show different views on reality


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Term

Synonym

Definition

Concept
definition


A concept definition is the explanation of the meaning of the concept. The concept definition may be
provi
ded wholly by the concept designation, with or without additional text etc. (see concept
representation), but particularly in large code systems that employ description logic or similar ontological
functionality, the full definition of the concept may requ
ire knowledge of its relationship to other concepts
within the code system.

Concept
designation


A concept designation
is a language symbol for a concept that is intended to convey the concept meaning to
a human being. A concept designation
may also be known as an appellation, symbol, or term, this latter
being the most common synonym.

A
concept designation

is typically used to populate the 'displayName' property of an ISO 21090 CD data
type.

Concept
domain


A concept domain is
a sentence
or paragraph that defines the semantic space (the totality of meaning that
can be expressed by the concepts that can be used) for the “thing" that a coded attribute in an information
model is to encompass, plus examples of these “things”.

䙯爠數amp汥: 慮 i
nformation model class is “car” and the coded attribute is “manufacturer”; the concept
domain is “The company that makes/markets the car to the general public; examples include General
Mo瑯牳Ⱐ䙯牤 MoWo爠romp慮y⁡湤⁍敲捥T敳
-
Benz”.

䍯n捥灴
楤敮瑩晩敲


䄠c
on捥灴c楤敮瑩晩敲e楳i
愠vo捡cu污ly ob橥j琠瑨慴W
un慭b楧uou獬礠慮T g汯b慬ay un楱u敬e 牥灲敳enW猠愠捯n捥pW
睩瑨楮 瑨攠 捯n瑥硴 o映 愠 捯T攠 獹獴sm 楮 愠 ma捨cn攠 牥慤慢汥l 睡y.

䄠 捯nc数琠 楤敮瑩晩敲e con獩獴猠 o昺 捴桥c 佉O fo爠 CoT攠 卹獴sm ⬠ CoT攠 (⬠ M敳楧n慴aonIM楳i污l n
慭e⤮

To make a Concept Identifier human readable, the “display name” (the designation) is added thus: the OID
景爠CoT攠Sy獴sm ⬠CoT攠(+ M敳楧n慴aonIM楳i污y n慭e⤮) 周攠Te獩sn慴楯n ⡤(獰s慹 n慭攩 楳ino琠m慮T慴o特rin
瑨攠 䥓传 21090 con捥灴c iT敮瑩晩敲Ⱐ bu琠 楴

楳i 捯n獩s敲敤e gooT 瑥rm楮ology p牡捴楣攠 Wo 慬睡y猠 Uav攠 瑨e
T敳楧n慴楯n⁦o爠獡r整y⁲ 慳on猠sT慴a⁵ 獣牡mb汩ng⁥瑣⸩
2
.

Concept
representati
on


A concept representation is
a
vocabulary object

that enables the
description and manipulation of a c
oncept

in sys
tems and applications (such as information models, xml schema).

A concept representation is minimally formed by putting together a code and a designation. However, a
concept representation in a code system may also be augmented with additional text, annot
ations,



2

Debate as to whether the display name should be carried in a concept identifier continues. There are a signific
ant group who feel that the display name should
not be carried.


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Title:


Metadata Definitions

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Term

Synonym

Definition

references and other resources that serve to further identify and clarify what the concept is.

Value set



A value set is
a uniquely identifiable set of valid concept identifiers that instantiate a concept domain in use
(in an application, an xml
instance etc.) where any concept identifier used can be tested to determine
whether it is a member of the value set at a specific point in time.

Value sets exist to instantiate the permissible content of a concept domain for a particular use in an
informat
ion model vocabulary binding, in analysis, in UI data collection
-

in a pick list (drop
-
down box), etc.

A value set is useful only in the context of instantiation of an attribute in an information model, not as a
stand
-
alone object (this is in contrast to
a code system, which exists in its own right).



4.4

Interoperability

Term

Synonym

Definition

Semantic
Interoperabil
ity


FDA guidance

“Interoperability” means the ability to communicate and exchange data accurately, effectively,

securely, and consistently
with different information technology systems, software applications,

and
networks in various settings, and exchange data such that clinical or operational purpose

and meaning
of the data are preserved and unaltered.


Technical interoperability
describes t
he lowest level of interoperability whereby two different systems
or organizations exchange data so that the data are useful. There is nothing that defines how useful.
The focus of technical interoperability is on the conveyance of data, not on its mean
ing. Technical
interoperability supports the exchange of information that can be used by a person but not necessarily
processed further. When applied to study data, a simple exchange of nonstandardized data using an
agreed
-
upon file format for data exchan
ge (e.g., SAS transport file) is an example of technical
interoperability.

Semantic interoperability
describes the ability of information shared by systems to be understood, so
that nonnumeric data can be processed by the receiving system. Semantic inter
operability is a multi
-

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Term

Synonym

Definition

level concept with the degree of semantic interoperability dependent on the level of agreement on
data content terminology and other factors. With greater degrees of semantic interoperability, less
human manual processing is require
d, thereby decreasing errors and inefficiencies in data analysis. The
use of controlled terminologies and consistently defined metadata support semantic interoperability.

Process interoperability
is an emerging concept that has been identified as a requi
rement for
successful system implementation into actual work settings. Simply put, it involves the ability of a
system to provide the right data to the right entity at the right point in a business process.



4.5

data aggregation



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5

REFERENCES

& RELATED DOCUMENTs


Related Documents

Reference
No.

Document Name

Filename

[F
DA
1]

Guidance for Industry. Providing Regulatory
Submissions in Electronic Format


Standardized
Study Data
-

DRAFT GUIDANCE . February 2012


http://www.fda.gov/downloads/Drugs/Guid
ances/UCM292334.pdf


[CDISC1]

CDISC Glossary
-

2009

http://www.cdisc.org/stuff/contentmgr/file
s/0/08a36984bc61034baed3b019f3a87139/
misc/act1211_011_043_gr_glossary.pd
f

[
ISO
1]

ISO1179
-


ISO/IEC 11179 Metadata Registry (MDR)
standard

Accessible on ISO site

[
ISO2
]

ISO2109

ISO 21090 Healthcare Data Type Standard

Accessible on ISO site (draft version
available on Internet)


Status

Name

Company

Date

Signature

Author





Author





Author





Author











6

Appendices

6.1

CDISC glossary