Data Field, Definition, Data Type, And Format Are All Common Data Elements In What?

This document provides information virtually the National Cancer Plant Common Data Elements (CDEs) developed with the Cancer Therapy Evaluation Program (CTEP). For questions concerning CTEP data in the caDSR, please contact the NCI CTEP CDE Compliance Review Team.

Introduction to CDEs

Common Data Elements (CDEs) are standardized terms for the drove and exchange of data. CDEs are metadata; they draw the type of data being collected, not the data itself. A basic example of metadata is the question presented on a form, "Patient Name," whereas an example of data would be "Jane Smith."

Overview of the CDE Project

The National Cancer Constitute (NCI) developed the CDE initiative to address the need for consistent cancer research terminology. To date, the Cancer Therapy Evaluation Programme (CTEP) has focused its CDE efforts on metadata used in information drove and reporting for stage three clinical trials, by standardizing terminology for questions and values on case study forms (CRFs). The goals of this project are the post-obit:

• to identify detached, divers items for information collection
• to promote consistent information collection in the field
• to eliminate unneeded or redundant data collection
• to promote consequent reporting and analysis
• to reduce the possibility of error related to data translation and manual
• to facilitate data sharing

Developing CDEs

To build its collection of CDEs, CTEP has established a collaborative process to engage members of skilful committees to identify and define disease-specific terminology. Members of these committees include representatives from NCI and the Clinical Trials Cooperative Groups who are involved in study pattern, implementation, information drove, and analysis.

The CDE disease committees consider terms that are being used in their subject field to determine whether at that place is a full general need for each, too equally what other terms may be needed. The committee so develops consensus to standardize the linguistic communication for the question and any associated values. Where possible, committees base the language and values on established standards, such equally the Commission on Cancer, the American Joint Committee on Cancer, the World Health Organization, and NCI resources.

As a outcome of the commission meetings, CDEs are identified, defined, refined, and classified. Template CRFs, which provide a graphic representation of the "core" CDEs for each disease, are besides created during these meetings. The designation of a CDE every bit "core" for a illness indicates the committee'southward determination that it is likely to be used for most stage three clinical trials. Other CDEs, for which a less frequent need is anticipated, are marked as "non-core" for the affliction.

Collections of disease-specific CDEs take been developed and released for public apply for bladder, breast, colorectal, gynecologic, lung, prostate, and upper gastrointestinal cancers, every bit well as for melanoma and leukemia. In improver, proficient committees were also established in collaboration with the Special Programs of Research Excellence (SPORES) program to develop CDEs related to pathology and specimen banking; these collections of CDEs have also been released and are bachelor for employ by the oncology community.

Disease committees were convened in 2002 to develop CDEs for encephalon and caput and neck cancers, besides as for lymphoma, myeloma, sarcoma with release in Fall 2003. An effort is besides in progress to develop CDEs specific to pediatric clinical trials and a plan to expand the effort to create CDEs for phase 1 and 2 clinical trials.

Using CDEs on CRFs

Once CDEs for a disease are released by CTEP, these CDEs must be implemented on CRFs for all phase three studies of that illness submitted to CTEP. A review process has been established to compare the CRF questions and values for a submitted protocol with existing CDEs. The outcome of this comparing is a series of reports that indicates whether CRF questions and values match the standard language of existing CDEs.

If the language of a question or its corresponding values do not match a CDE with a related definition, it is recommended that the CRF be revised to supercede the CRF question and values with the existing CDE. If there is a match for neither language or pregnant, a new term is developed for temporary apply. This CDE may be used on the CRFs for the submitted protocol but will not exist released for general utilize until it has been reviewed and approved past the appropriate CDE illness committee.

NCI CDEs are stored in the caDSR, a robust metatdata registry developed and maintained by the NCI Center for Bioinformatics and Information technology (CBIIT), and storing important attributes that are useful both to those amalgam CRFs and to those developing information systems. The CDE Browser is the primary user interface to search, browse, and export CDEs from the caDSR and offers information regarding the development and use of CDEs for the oncology community.

Awarding of ISO 11179 to CDEs

Understanding ISO 11179

The framework of the caDSR is based on ISO 11179: Information Technology - Metatdata Registries . Just as the goal of CDEs is to facilitate the sharing of data through common linguistic communication, the goal of ISO 11179 is to facilitate the sharing of metadata though a mutual data model. As such, this standard specifies the information (that is, attributes and associated administered components) that need to be stored for each CDE and how the data should exist stored. CBIIT has provided documentation on the caDSR wiki about how it has implemented this standard.

An ISO 11179 database is organized into Contexts. A Context may represent a business unit of measurement or some other content division. All administered components within the database are associated with a Context, either that in which they originated or are used. In the caDSR, Contexts represent NCI programs and divisions. All CDEs that were created by CTEP are associated with the "CTEP" Context. The caDSR also allows for Contexts to signal their endorsement of a CDE created by another program or division. Such a designation indicates to users that the CDE is approved for use in this other Context every bit well.

ISO 11179 Terminology

An administered component is an item about which administrative data is collected. Iv types of administered components are integral to an ISO 11179 database. Additional types of administered components also exist within the ISO 11179 data model and the caDSR.

The almost familiar of these 4 is the Data Element. A Information Element is the basic unit of measurement of information that is being collected in an ISO 11179 database, a metadata descriptor. Information technology represents a semantic concept and indicates the specific type of information to be collected. Data Elements are named and defined in a standardized fashion according to Context-specific naming conventions. Within the "CTEP" Context, a Data Element can be thought of equally a question on a CRF.

A Data Chemical element Concept is similar in nature to a Information Element. It represents a semantic concept merely is not tied to a specific data type. A Information Element Concept may, therefore, be associated with several Data Elements representing the same semantic concept. For example, the Data Elements "Patient Residence Land Code" and "Patient Residence Country Name" both stand for the aforementioned semantic concept of "Patient Residence Country."

A Value Domain describes in detail the type of data to exist nerveless, independent of the semantic concept. Attributes of a Value Domain include data type, maximum and minimum field lengths, high and low values, unit of measure, and number of decimal places. A Value Domain may also include an enumerated listing of specific Valid Values. Within the "CTEP" Context, a Value Domain describes the type of information that is existence collected by a question on a CRF. If there is an enumerated list of Valid Values, it is those Valid Values that may appear on the CRF as potential answers.

A Conceptual Domain is a drove or description of related Value Meanings. A Value Meaning is the essence of the information that is existence collected, rather than the bodily data itself. For case, a response to the question, "Patient Name" might be "Jane Smith". "Jane Smith" is actual data, whereas the essence of the data is "the name of a person." Some other example is the question, "Country of Residence," which includes equally responses the 2-letter of the alphabet code for each country in the world. The codes would be Valid Values in a Value Domain, just the Value Meanings would be the list of countries in the world.

Basic Relationships of Administered Components

ISO 11179 specifies that each Information Element is associated with i and only i Information Element Concept and with i and only 1 Value Domain. In this fashion, the combination of a Data Element Concept and Value Domain define a Data Element.

Each Data Element Concept and each Value Domain are associated with one and only 1 Conceptual Domain. For a given element, the Data Element Concept and Value Domain exercise non take to exist associated with the aforementioned Conceptual Domain, although they might be.

Naming Data Elements

ISO 11179 requires that Data Elements be named in a consistent way, allowing for easier searching and retrieval of information. CTEP has developed naming conventions for Information Elements associated with the "CTEP" Context of the caDSR. Delight refer to CTEP's Naming Conventions for a total explanation of these rules and guidelines.

Most names are composed of 1 or some combination of the following types of terms, defined by ISO 11179 equally the basic components of Data Elements and other administered components.

Component of Data Element Names	Definition	Example
Object Class term	thing about which information is being collected; within the "CTEP" Context, typically represents an object or action	Treatment
Property term	a feature or possession of the Object Form	Report Period
Representation term	specifies the form of the data that is being collected	Date
Qualifier	a modifier that describes any other term, similar to an describing word; inside the "CTEP" Context, qualifiers should be used sparingly because of express name lengths	Stop

Data Element Long Proper noun

A Information Chemical element Long Proper noun is composed of ane Object Grade term, i Property term, and one Representation term. A maximum of three Qualifiers (optional), ane modifying each of the other terms, may be added to the name if needed to further clarify the proper name or to go far distinct from other Data Element Long Names. Information Element Long Names must be unique and distinct from one another.

The Object Class term shall occupy the first position in the name and the Belongings term shall occupy the 2d position. A Qualifier shall straight precede the term it modifies. The Representation term shall occupy the terminal position in the name.

Words or terms in the name are to be separated by spaces. No punctuation or abbreviations are to be used. Each discussion should have the initial letter in uppercase, with all others in lower-case, unless the word is usually written otherwise.

The total length of the proper noun, including spaces, is restricted to a maximum of 120 characters.

Instance: Treatment Report Flow End Date

Data Chemical element Brusk Name

A Data Chemical element Brusk Proper noun is an abbreviated form of the Data Chemical element Long Proper name; it is, therefore, composed of ane Object Class term, 1 Property term, and one Representation term, and up to a maximum of three Qualifiers, one modifying each of the other terms. The Data Element Long Name is to exist adamant commencement, and then abbreviated as described below. Data Chemical element Preferred Names must be unique and singled-out from one some other.

The Object Grade term shall occupy the first position in the name and the Holding term shall occupy the second position. A Qualifier shall directly precede the term information technology modifies. The Representation term shall occupy the final position in the name.

Words or terms in the name are to be separated by underscores. No punctuation is to be used. The proper name should be written in upper-case letter.
The total length of the proper name, including underscores, is restricted to a maximum of 20 characters. All words are to be abbreviated if a standard abbreviation has been determined by CTEP. If later on abbreviations are implemented, proper noun length exceeds 20 characters, unabbreviated terms will be truncated to three letters every bit needed in the order of Qualifiers, Property term, Representation term, Object Form term.

Example: TX_REPPD_END_DT

Best Practice Recommendations have approved system-generated curt name (preferred name) in curation for CTEP CDEs.  The following recommendation was approved on Content Meeting on 12/14/09:

• Curators should retain arrangement-generated curt names created by the curation tool
• If user-entered short names are required, follow the guidelines imposed past the consuming application and register an alternate name in caDSR with the appropriate Alt Name Type
• For items that are moved into OC systems alternate names will demand to be created
• Standards based short name (DICOM, HL7) should follow best practice

Representation Terms

Below is the electric current list of Representation terms used by CTEP in naming Data Elements.

Representation term	Definition
Date	agenda date
Time	time of day
Date/Time	combined date and fourth dimension
Interval	length of fourth dimension between specified events
Duration	length of occurrence of an event (number/time catamenia)
Frequency	how oftentimes an event occurs (e.g., daily, weekly)
Age-Months	age in months
Age-Years	age in years
Number	assigned identifier (e.g., patient number, specimen number, phone number, cycle number, treatment arm number)
Count	quantity, number of items
Dose	amount of therapy administered or prescribed to or taken by a patient
Measurement	dimensions or chapters of an object, or resulting calculation (due east.g., bore, area, volume)
Value	numeric laboratory measurement
LLN	lower limit normal
ULN	upper limit normal
UOM	units of measure
Rate	relationship between two numbers (east.g., blood pressure charge per unit)
Average	mathematical mean
Form	numerical scale to describe extent of something, assigned according to standard criteria
Stage	disease staging, assigned according to standard criteria
Score	number assigned from standardized test or procedure
Amount	numeric value of otherwise unspecified type
Ind	response to a yes/no question; includes yeah, no, unknown, not available, non assessed, etc.
Ind-ii	response to a yes/no question; includes yes, no
Ind-3	response to a yep/no question; includes aye, no, unknown
Name	designation for a person or object
Code	values that substitute for others
Email	e-mail accost
Procedure	enumerated list of treatment procedures
Site	anatomic site
Reason	explanatory action
Source	source of information provided
Category	classification
Scale	spectrum of values
Status	response to a binary question (e.1000., positive/negative, left/right)
Blazon	list of values of otherwise unspecified type
Specify	free-text description where needed value was not available in associated/related question (i.eastward., "Other, specify")
Text	free-text description of procedure or event

Character Prepare and Symbols

The caDSR and CTEP'southward naming conventions make employ of the standard ASCII graphic symbol gear up in all administered component names, Valid Values, and Value Meanings. This character set includes all messages in the Latin alphabet (A through Z), in both lower- an upper-example and numbers 0 through 9. The post-obit boosted characters are included:

<space>  `  ~  !  @  #  $  %  ^  &  *  (  )  -  _  =  +  \  |  [  ]  {  }  ;  :  '  "  ,  <  .  >  /  ?              

All Long Names and Preferred Names may merely begin with a letter. Valid Values and Value Meanings may begin with symbols unless restricted by the software being used.
Conventions take been established by CTEP for other symbols and formatting that may be needed for Document Text entries or Valid Values.

• Superscript will be indicated by the symbol ^ (e.g., x^3)
• Subscript will exist indicated by the symbol \ (e.g., A\2)
• Symbol for degrees volition be written out equally "degrees"
• Symbol for plus or minus will be indicated past +/-
• Symbol for check mark volition exist written out as "check"
• Symbol for less than or equal to will exist indicated by <=
• Symbol for greater than or equal to will exist indicated past >=

Using the CDE Browser

Overview of the CDE Browser

The CDE Browser (http://cdebrowser.nci.nih.gov) is the principal user interface for the caDSR. It is a public web site that has a real-time connectedness to the caDSR, so users of the CDE Browser run into updates and edits immediately as they occur.

Using the CDE Browser, users can search, browse, and export Data Elements from the caDSR. The CDE Browser also provides users access to view CDE collections and template CRFs developed by the CTEP CDE disease committees and others.

Definition of Terms

Fields that announced in the CDE Browser are defined beneath.

Field in CDE Browser	Definition
Information Element	the basic unit of data that is being collected in an ISO 11179 database, a metadata descriptor. Within the "CTEP" Context, a Data Element can be thought of a question on a CRF, may as well be referred to as a CDE.
CDE ID	a unique seven-digit identifier assigned to each Data Element, may besides be referred to every bit the Data Element'due south Public ID; each Data Element has one and only one CDE ID.
Preferred Proper noun	the field that stores the short, twenty-xxx character name ("computer" name) of a Data Element; other administered components (i.e., Value Domains, Data Element Concepts, and Conceptual Domains) also accept Preferred Names.
Long Proper name	the field that stores the primary proper noun of a Data Element; other administered components (i.e., Value Domains, Information Chemical element Concepts, and Conceptual Domains) too have Long Names.
Certificate Text	the field in which additional Data Chemical element names or documentation may exist stored. Document Text associated with a Document Type of "Long Name" ("Long Name" in old CDE Browser) or "Historic Brusk CDE Name" ("Short Proper name" in old CDE Browser) are additional Data Element names, often containing the text or question most likely to be used on a CRF. Instructions volition exist associated with a Document Type of "Comment".
Context	the business unit or other content division that is responsible for creating and managing associated content; in the caDSR, Contexts currently represent NCI programs and divisions.
Workflow Status	the authoritative status of a Information Chemical element or other administered component. Inside the "CTEP" Context, this refers to the Data Element's progress in the CDE illness committee review procedure. Delight refer to the caDSR Business organization Rules for definition and usage information for each workflow status.
Version	the version number of an administered component; the version number is incremented when significant changes are fabricated to an administered component. Delight refer to the caDSR Business organization Rules for an explanation of rules governing the cosmos of new versions of administered components.
Origin	the source of the administered component or standard on which it is based.
Historical CDE ID	a number that was previously assigned to a Data Element as an identifier; a Data Element may have many Historical CDE IDs.
Public ID	the unique 7-digit identifier assigned to each administered component, for a Data Element may besides be referred to as the CDE ID; each administered component has one and simply ane Public ID.
Designation	the indication past a Context of their endorsement of a Data Chemical element created by another program or division, may likewise be referred to as "Used By"; indicates to users that the Data Element is approved for utilise in this other Context as well. Please refer to the caDSR Business organization Rules for more information about the use of designations.
Information Element Concept	the representation of a semantic concept without ties to a specific data type, like in nature to a Data Element.
Value Domain	the collection of attributes that describe in detail the type of data to exist collected. Inside the "CTEP" Context, a Value Domain describes the blazon of data that is being collected by a question on a CRF. If at that place is an enumerated list of Valid Values, it is these Valid Values that appear on the CRF as potential answers.
Valid Values	the enumerated responses, divers past Value Meanings, associated with a Data Element through its associated Value Domain, may also be referred to every bit "Permissible Values". Inside the "CTEP" Context, values that appear on the CRF every bit potential answers to a question. Value Meaning: the essence of the data that is being collected, rather than the actual data itself.
Conceptual Domain	a drove or description of related Value Meanings
Classification	the relational categorization of Data Elements or other administered components for purposes of organization and ease of searching. Within the "CTEP" Context, classifications indicate the collections of Data Elements approved through the CDE disease committee review process and group Data Elements according to likely class apply.
Classification Scheme	a defined system for categorizing Data Elements or other administered components, may besides be referred to as "CS"; a Classification Scheme is composed of related Nomenclature Scheme Items that serve as categories defining the scope of the scheme. Within the "CTEP" Context, there are 3 main Classification Schemes: "Disease", "Trial Type Usage", and "Category".
Classification Scheme Item	a category within a Classification Scheme to which Data Elements or other administered components may be assigned, may too be referred to every bit "CSI".
Core	the designation by a affliction committee of a Data Element, indicating the committee'southward determination that it is likely to be used in nearly stage iii clinical trials; used on one or more than template CRFs.
Non-core	the designation by a illness committee of a Date Element for which a less frequent need is predictable; does non appear on any template CRFs for the disease.

Locating CDEs

The CDE Browser provides two master mechanisms for locating CDEs.

The starting time of these is to enter search criteria in the text boxes on the correct frame of the screen. You may search past keyword or CDE ID. In add-on or instead, you may search past associated Value Domain or Information Element Concept, Workflow Status(es), and Classification assignments. Yous may also specify whether y'all wish to retrieve all versions of each matching CDE or only the near contempo version; in most cases, the latest version will exist the canonical or "Released" version of the Data Element. Keyword searches can be limited to one or more types of Data Element names, if preferred. Searches by CDE ID will search both CDE IDs and Historical CDE IDs.

The second machinery for locating CDEs is to utilise the navigation tree in the left frame. Each time you click on a node in the tree, all CDEs associated with that Context, Classification Scheme, Classification Scheme Item, or Protocol Form Template (template CRF) are displayed in the right frame under the search criteria. Navigation Links are displayed at the bottom of the frame so you lot may view a different folio of CDEs.

You may besides utilise a combination of these mechanisms, clicking on a node in the navigation tree and so entering search criteria. The criteria will just be matched against the CDEs associated with the selected Context, Classification Scheme, Classification Scheme Item, or Protocol Class Template. If you do not click on whatever nodes or if you click on "caDSR Contexts," your search criteria volition be matched against all CDEs in the caDSR.

You can detect CTEP CDEs past clicking on "NCI Cancer Therapy Evaluation Program (CTEP)" in the tree. You may farther refine your search by clicking on the CTEP binder icon. From here, you may click on "Protocol Grade Templates" or "Classifications".

"Protocol Class Templates" permit you to search, by Phase or Illness, the CDEs contained on each template CRF developed by the CDE illness committees. These template CRFs are intended to provide examples of use of the most mutual CDEs for a item illness. Inside each affliction, forms are classified farther by type of grade and report stage. Once you lot take selected a template CRF, y'all can view the template CRF in Microsoft Word or download the associated CDEs using XML or Excel; these links are nether the "Search Data Elements" and "Clear" buttons. You lot may besides browse the details of the associated CDEs online.

"Classifications" permit you to search the CDEs by category. "Type of Category" classifies CDEs by their typical utilize in a clinical trial (due east.g., Patient Demographics, Labs, Agin Events). "Type of Disease" categorizes CDEs by disease, according to the decisions of the CDE disease committees. "Trial Type Usages" provides nomenclature by disease phase or disease clarification, co-ordinate to employ on template CRFs.

"Type of Affliction" allows y'all to search the CDEs by CDE disease committee designation as "cadre" or "non-core".

Once a list of CDEs has been selected, either through searching or use of the navigation tree, y'all may view the details of each individual element online or the entire list may be downloaded using XML or Excel. To download selected CDEs, click on the appropriate link for the preferred format (XML or Excel); these links are under the "Search Data Elements" and "Clear" buttons. The Excel download contains the almost pertinent details for each Data Chemical element, including the names of the associated Information Element Concept and Value Domain, and all of the associated Valid Values. The download in XML provides significant detail, including many of the attributes specified in ISO 11179 for each Information Element. The DTD used past the CDE Browser to download Information Elements shows the fields from which data is included and how the information is ordered.

CDE Details

One time you take located the desired CDE by searching or using the navigation tree, you lot may click on its underlined Preferred Name to view its details online. This will open up a popular-upwardly window with five tabs. Those that will be of nigh utilize to the general CTEP user include Data Chemical element (details about the CDE), Valid Values (attributes of the associated Value Domain and Valid Values), and Classifications (categorization of the CDE).

Building Case Report Forms (CRFs)

Using CDEs on CRFs

In one case CDEs for a disease are released past CTEP, they must exist implemented on CRFs for all phase 3 studies of that illness submitted to CTEP. Collections of disease-specific CDEs have been developed and released for public apply for bladder, breast, colorectal, gynecologic, lung, prostate, and upper gastrointestinal cancers, also as for melanoma and leukemia. The exact linguistic communication of the CDE, both Data Element name and Valid Values, must be used.

CDEs that have been approved for use on CRFs being submitted to CTEP include those that take "CTEP" every bit their Context or designating Context and as well have "Released" or "Released-non-compliant" as their Workflow Status. CDEs in the CTEP Context with other Workflow Statuses are either in the process of being reviewed by a illness committee or accept been retired or removed from use. Delight consult the Workflow Status definitions for more than information.

Entries in the post-obit fields may exist used as questions on CRFs: Long Name, or entries in Certificate Text of Blazon "Long Name" or "Celebrated Short CDE Proper name". When choosing a CDE to apply, look carefully at its names and definition to determine whether it is appropriate for your needs. For a given CDE, the unabridged set or a subset of the Valid Values may be used as answers to a question.

If you cannot locate a "Released" or "Released-non-compliant" CDE that is advisable for the question yous would similar to ask on your CRF, aggrandize your search to include CDEs with other Workflow Statuses. Many of these CDEs are currently existence reviewed past the CDE disease committees, but special blessing may be given for their apply on your CRFs if suitable and in that location are no "Released" terms that might exist recommended. Specifically, you might wait for CDEs with the following Workflow Statuses: Committee Approved, Committee Submitted Used, Approved for Trial Utilize, Draft Modern, Draft New, Committee Submitted, Retired Withdrawn.

If you are unable to locate any CDEs that are appropriate for the question you would similar to ask, please give-and-take the question in a mode similar to other CDEs and submit it on your CRF. The reviewers will conduct an extensive search to decide if there is an existing CDE to recommend or if there is need for a "Draft New" CDE to be created.

For questions concerning CTEP data in the caDSR, please contact the NCI CTEP CDE Compliance Review Squad.

CDE Compliance Review

When your CRFs have been developed, submit them to CTEP's Protocol and Data Office (PIO), who will frontwards them to the CDE reviewers for compliance review. It is preferred that the CRFs be submitted every bit due east-mail attachments without security that prevents copying text from the files.

The initial review consists of three Excel spreadsheets that report the results of the CDE Compliance Review and a statement of whether the CRFs are considered CDE-compliant.

The Question Comparison Study indicates for each CRF question whether it was considered an exact lucifer to an existing CDE, whether it should be replaced with a recommended term, or whether it has been created as a new element to meet the specific needs of the protocol. Where indicated, a response will be required of you in the Group Comments column, such as whether you agree with and will employ the recommendations or would like to advise another Data Element for use.

The Valid Value Comparison Written report indicates whether, for each CRF question, each CRF valid value was considered an exact match to an existing value, whether it should exist replaced with a recommended term, or whether information technology has been created every bit a new value to meet the specific needs of the protocol. Once more, where indicated, a response will exist required equally to whether you agree with and will use recommendations or would similar to suggest another Valid Value or Data Chemical element for use.

The Proposed New Data Elements Study includes those CRF questions for which there was no possible friction match in the dictionary. It is requested that you develop the definition for each of these and then new Data Elements may be created. Use of these new Information Elements is allowed on a one-time ground for the particular protocol for which they were created; they volition also be forwarded to the advisable CDE disease committee as part of the CDE change direction process. If approved past the committee, these Information Elements volition be published and will exist available for use in time to come studies.

Unless the CRFs are CDE-compliant, a response is required of you. Please indicate your responses, where required, on the three spreadsheets and submit these and your revised forms for re-review. The same review process will be conducted on whatsoever non-compliant questions, as well as any questions or values new to or modified on the CRFs.

When the CRFs are CDE-compliant, last spreadsheets indicating the CDE ID numbers used will exist sent to you through PIO and to the Cancer Trials Support Unit (CTSU), if appropriate.

It is required that y'all resubmit your CRFs when any changes are made to them. To speed the review process, please include a memo outlining what changes were made.

CDE Development

The development of CDEs has been a collaboration of CTEP and the Clinical Trials Cooperative Group Programme, Specialized Programs of Research Excellence (SPOREs), the Cancer Biomarkers Research Group, the Early Detection Research Network, NCI Center for Bioinformatics, Oracle Corporation, and The EMMES Corporation.

Standards Leveraged by the CDE Project

The CDE project extensively leverages all existing piece of work supporting the collection of mutual data, such as the CRFs, surveys, and data reporting formats developed by a variety of groups.

• Expanded Participation Project (EPP)
• Clinical Data Update Organization (CDUS) through the Cancer Therapy Evaluation Plan (CTEP)
• Clinical Trials Cooperative Group Programme
• Cancer Family Registry
• Cancer Genetics Network
• Early Detection Research Network (EDRN)
• Lung Cancer Biomarker Chemoprevention Consortium (LCBCC)
• Specialized Programs of Research Excellence (SPOREs)

The following cancer-specific standards have also been considered in developing CDEs:

• American Joint Commission on Cancer (AJCC)
• American College of Surgeon'south Commission on Cancer (COC)
• NCI's Surveillance Epidemiology and End Results (SEER) program
• Northward American Association of Central Cancer Registries (NAACCR)

The following national and international standards and standards organizations were consulted in developing CDEs:

• Earth Health Organization (WHO)
• International Nomenclature of Diseases (ICD)
• Standard Industry Classification (SIC)
• National Drug Codes (NDC)
• International Medical Terminology (IMT)
• Medical Dictionary for Regulatory Activities (MedDRA)
• Unified Medical Language System (UMLS)
• Digital Imaging and Communications in Medicine (DICOM)

Refer to the Glossary at the terminate of this certificate for a more than complete listing of all organizations contributing to the standards used in CDE development.

Disease Committee Participation

The disease and special topics committees include representatives from one or more groups listed below. Oracle Corporation and The EMMES Corporation provide technical support to the CDE project.

• Cancer Therapy Evaluation Program (CTEP)
• Lung Cancer Biomarkers and Chemoprevention Consortium (LCBCC)
• American College of Surgeons Oncology Group (ACOSOG)
• Cancer and Leukemia Grouping B (CALGB)
• Children's Oncology Group (COG)
• Eastern Cooperative Oncology Group (ECOG)
• European Organization for Research and Handling of Cancer (EORTC)
• Gynecologic Oncology Grouping (GOG)
• National Cancer Institute (NCI)
• National Cancer Institute of Canada (NCIC)
• National Surgical Adjuvant Chest and Bowel Project (NSABP)
• New Approaches to Brain Tumor Therapy (NABTT)
• North Fundamental Cancer Handling Grouping (NCCTG)
• Radiation Therapy Oncology Group (RTOG)
• Southwest Oncology Group (SWOG)

Glossary

Acronyms and Abbreviations

Clinical Trials Cooperative Groups

CTEP CDE Category Definitions

Category	Definition
Adverse Events	CDEs that characterize the untoward effects of the therapeutic intervention using the Common Toxicity Criteria (CTC) and Common Terminology Criteria for Adverse Events (CTCAE), to consistently grade the severity of the event and to provide information as to whether the handling may have been a crusade.
Cytogenetics	CDEs that characterize the results of cellular analysis to identify genetic abnormalities present in cancer by examining cellular components concerned with the construction and office of chromosomes responsible for development and differentiation of cells.
Disease Description	CDEs that characterize the disease, such as diagnosis, location, and extent. Eligibility Criteria: CDEs that characterize the criteria used to appraise whether the individual is eligible for the clinical trial or written report.
Follow-up	CDEs that characterize the sequential assessment of the disease or vital status of the individual, such as progression, long-term toxicity, and date of death.
Immunophenotype	CDEs that characterize the results of assay to divide leukemias and lymphomas into clonal subgroups on the basis of differences in their cell surfaces and cytoplasmic antigens, detecting these differences using monoclonal antibodies, flow cytometry, etc.
Labs	CDEs that characterize the results of laboratory tests such as LDH, WBC, creatinine, and glucose. Molecular Analysis: CDEs that characterize the results of genetic tests to place abnormalities present in cancer that are related to the chemical structure, function, replication, and mutation of DNA and RNA molecules in the manual of genetic information, and wellness furnishings relating to factor organisation and RNA transcription to direct the formation of proteins.
Patient Characteristics	CDEs that characterize the health and emotional land of the individual enrolled on the study including treatments for a prior cancer.
Patient Demographics	CDEs that narrate the individual enrolled on the report, such as proper name, address, date of birth, weight, and height.
Protocol/Administrative	CDEs that narrate the regulatory, reporting, and data management aspects of clinical trials, such every bit IRB date and protocol number.
Response	CDEs that characterize the outcome of the study, such as overall tumor response, partial response, and beginning appointment observed.
Treatment	CDEs that characterize the properties of the intervention regimen, such as agent, dose, procedure, and modalities.
Tumor Markers	CDEs that narrate biological markers for presence or level of involvement; specific to a affliction, such as PSA, CA125.

CDE Terms

CDE Term	Definition
Administered component	an detail nearly which administrative information is nerveless. A Data Element is the virtually familiar type of administered component, although many administered component types exist within an ISO 11179 database and within the caDSR.
caDSR	Cancer Information Standards Registry and Repository, a robust metadata registry, developed and maintained by the NCI Center for Bioinformatics and Information technology, that stores NCI CDEs and related attributes.
Example report form (CRF)	a data drove form.
Instance report form (CRF) module	a collection and sequence of elements grouped to provide context for the information requested past the CRF questions.
CDE Browser	the main user interface (http://cdebrowser.nci.nih.gov) to search, browse, and export Data Elements from the caDSR.
CDE ID	a unique seven-digit identifier assigned to each Data Element, may too be referred to as the Information Element's Public ID; each Information Chemical element has one and only one CDE ID.
Classification	the relational categorization of Data Elements or other administered components for purposes of system and ease of searching. Within the "CTEP" Context, classifications indicate the collections of Data Elements canonical through the CDE disease committee review process and group Data Elements according to likely form utilize.
Nomenclature Scheme	a defined system for categorizing Information Elements or other administered components, may also be referred to as "CS"; a Nomenclature Scheme is composed of related Nomenclature Scheme Items that serve equally categories defining the scope of the scheme. Within the "CTEP" Context, there are 3 main Classification Schemes: "Illness", "Trial Type Usage", and "Category".
Classification Scheme Item	a category within a Classification Scheme to which Data Elements or other administered components may be assigned, may also be referred to as "CSI".
Common information element (CDE)	a standardized term for the collection and exchange of data. CDEs are metadata; they draw the type of data being collected, not the data itself. A basic case of metadata is the question presented on a class, "Patient Name," whereas an example of information would exist "Jane Smith".
Conceptual Domain	a collection of or description of related Value Meanings; may be either enumerated or descriptive only.
Context	an organizational sectionalisation inside an ISO 11179 database. A Context may represent a business organisation unit or some other content division that is responsible for creating and managing associated content. All administered components within the database are associated with a Context, either that in which they originated or are used. All CDEs that were created by CTEP are associated with the "CTEP" context.
Core CDE	a Data Chemical element that is included on one or more than template CRFs. The designation of a CDE as "core" for a disease indicates the committee's determination that it is likely to be used in well-nigh phase three clinical trials.
Data Element	the basic unit of measurement of information that is being collected in an ISO 11179 database, a metadata descriptor. It represents a semantic concept and indicates the specific type of information to be collected. Data Elements are named and defined in a standardized manner according to Context-specific naming conventions.
Information Element Concept	the representation of a semantic concept without ties to a specific data type, similar in nature to a Information Element. Data blazon: the form in which data is beingness collected (eastward.g., character, date, integer) in response to a Data Chemical element; specified for each Value Domain.
Decimal Place	the number of places behind the decimal indicate in the response to a Information Element; specified for a Value Domain.
Definition	the detailed meaning of a Data Element or other administered component.
Designation	the indication by a Context of their endorsement of a Data Chemical element created past some other programme or sectionalisation, may also be referred to as "Used By"; indicates to users that the Data Element is approved for use in the designating Context too. Please refer to the caDSR Business organisation Rules for more data about the use of designations.
Certificate Text	the field in which additional Data Element names or documentation may be stored; names in this field are not spring past naming conventions.
Historical CDE ID	a number that was previously assigned to a Data Element equally an identifier; a Information Chemical element may have many Historical CDE IDs.
ISO 11179	Information technology - Metadata Registries (http://standards.iso.org/ittf/PubliclyAvailableStandards/alphabetize.html)  developed by the International Organization for Standardization and the International Electrotechnical Commission.
Long Proper noun	the field that stores the primary proper noun of a Data Element or other administered component.
Maximum length	the maximum number of storage units (of the corresponding information type) that may be used in representing the response to a Information Element; specified for a Value Domain.
Metadata	information (attributes) that describe the blazon of data existence collected.
Minimum length	the minimum number of storage units (of the corresponding data blazon) that must be used in representing the response to a Data Element; specified for a Value Domain.
Non-cadre CDE	a Information Chemical element for which a CDE disease committee anticipates a less frequent demand. Not-core CDEs are not included on any template CRFs for a affliction.
Object Class term	an administered component, frequently used in naming Data Elements; a matter about which data is existence nerveless.
Origin	the source of the administered component or standard on which it is based.
Stage 1 Clinical Trials	these first studies in people evaluate how a new drug should exist given (by oral cavity, injected into the blood, or injected into the musculus), how often, and what dose is safe. A phase 1 trial commonly enrolls only a small number of patients.
Phase 2 Clinical Trials	a phase 2 trial continues to test the prophylactic of the drug and begins to evaluate how well the new drug works. Phase two studies ordinarily focus on a particular type of cancer.
Phase 3 Clinical Trials	these studies test a new drug, a new combination of drugs, or a new surgical procedure in comparison to the current standard for treatment. A participant will usually be assigned to the standard treatment group or the new treatment grouping at random (chosen randomization). Phase 3 trials frequently enroll large numbers of people and may be conducted at many doctors' offices, clinics, and cancer centers nationwide.
Preferred Name	the field that stores the short, 20- or thirty-graphic symbol name ("computer" name) of a Data Chemical element or other administered component.
Holding term	an administered component, often used in naming Data Elements; a feature or possession of the object class.
Public ID	the unique 7-digit identifier assigned to each administered component, for a Information Element may as well be referred to equally the CDE ID; each administered component has one and only one Public ID.
Qualifier	an attribute, frequently used in naming Data Elements and other administered components; a modifier that describes any other term, similar to an adjective.
Representation term	an attribute, frequently used in naming Data Elements and other administered components; specifies the grade of the data that is being collected.
Template CRFs	a CRF developed as a guideline past a CDE disease committee to provide a graphic representation of the "core" CDEs for each affliction. The designation of a CDE every bit "core" for a disease indicates the committee's determination that it is probable to be used in most phase 3 clinical trials.
Valid Values	the enumerated response, defined by Value Meanings, associated with a Data Chemical element through its associated Value Domain, may also exist referred to equally "Permissible Values". Inside the "CTEP" context, values that will announced on the CRF every bit potential answers to a question.
Value Domain	the drove of attributes that describe in particular the type of data to be collected. Attributes of a Value Domain include data type, maximum and minimum field lengths, high and depression values, unit of measure, and number of decimal places. A Value Domain may too include an enumerated list of specific Valid Values.
Value Meaning	the essence of the data that is existence collected, rather than the actual data itself. For instance, a response to the question "Patient Name" might be "Jane Smith." "Jane Smith" is actual data, whereas the essence of the data is "the name of a person." Some other example is the question "Country of Residence," which includes as responses the two-alphabetic character code for each state in the world. The codes would be Valid Values in a Value Domain, but the Value Meanings would be the list of countries in the world.
Version	the version number of an administered component; the version number is incremented when pregnant changes are made to an administered component. Please refer to the caDSR Business Rules for an caption of rules governing the creation of new versions of administered components.
Workflow Condition	indication of the administrative condition of a Data Chemical element or other administered component. Within the "CTEP" Context, this refers to the Data Chemical element's progress in the CDE illness committee review process. Please refer to the caDSR Business Rules for definition and usage information for each workflow condition.

Additional Resources

• caDSR Wiki home page
• caDSR Users List - Notices of upgrades, new releases, new features, service inteeruptions
• Support - Help with any technical problem
• CTEP's CDE team - Questions about CTEP information and content

Data Field, Definition, Data Type, And Format Are All Common Data Elements In What?,

Source: https://wiki.nci.nih.gov/display/caDSR/CTEP+Common+Data+Elements

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