• CDISC Clinical Research Glossary
• CDISC Glossary, Acronyms, Abbreviations & Initials 
• CDISC Glossary Terms, Version 7.0 (word doc)

Your feedback will be most welcome!

The CDISC Protocol Representation Group is pleased to announce the availability of Version 1.0 of the CDISC Protocol Representation Model (PRM) Toolset, freely accessible on the CDISC website http://www.cdisc.org/protocol.

We have focused the initial release of the Toolset on the Clinical Study Outline. Within the industry, the Study Outline is also sometimes also referred to as the "Study Synopsis", or "Study Concept Sheet". The intended use is to provide an outline of the key concepts which define the study design prior to commencing authorship of the Protocol Document and related downstream activities such as the Data Collection Specification and CRF Design. The Study Outline is typically created for each study, and follows a Clinical Development Plan. Once reviewed and approved, the Clinical Protocol design process is initiated.

The purpose of the Toolset is to provide an evolving set of tools to assist organizations in implementing the use of the CDISC PRM V1.0 standard. This first release provides the two tools described below.

Study Outline Document Template

Conceptually, the Study Outline document facilitates review and agreement of an initial set of core study design parameters and attributes. These design elements include, as an example, Study Phase, Study Objectives, Study Endpoints and/or Outcomes, and Inclusion/Exclusion Criteria. Agreement upon these core concepts then drives the remaining content of the study design and ultimately the protocol, related documents, and various downstream activities and systems.

The CDISC Study Outline Document Template is a Microsoft Word 2007 document template that formats and presents the Study Outline Concepts List in document form. The document is ultimately the vehicle by which the Study Outline will be communicated to the study team and/or accountable parties. It is important to note that the document provides a visible and tangible means to implement the use of the Study Outline Concepts standard.

The intended use of this tool is to provide organizations a starting point for standardizing the Study Outline document within their respective organization. Conceptually, the CDISC template is to be considered the minimum set of suggested concepts, and organizations should feel free to expand as they see necessary for their needs.

Please note the document template provided is currently supported only with Microsoft Word version 2007 or above, and is not currently compatible with the Apple MacIntosh OS.

Follow the link to access the Study Outline Word Template. 

Study Outline Concepts List

The CDISC Study Outline Concepts List is a reference list of the individual concepts mapped to the superset of study design concepts (PRG Concepts Master) and related CDISC SDTM TS Domain standard TSPARMCD's. Mapping to the BRIDG model is also provided by way of the PRG Master Concept.

The intended use of this tool is to provide organizations a detailed mapping between the Study Outline Concepts, BRIDG, and SDTM and to serve as a reference which includes further explanation of the concepts and any related notes. This will help sponsors understand how the information entered into the Study Outline Document aligns and maps to both the BRIDG and SDTM standards in order to assist standardizing study design data across the various steps of the study lifecycle. As an example, the Study Phase selected in the Study Outline Document inherently is standardized with SDTM and CDASH, as well as any systems implemented using the BRIDG Domain Analysis model.

Follow the link to access the Study Outline Concepts.

Compatibility Requirements

The PRM Toolset Version 1.0 is compatible with CDISC SDTMIG version 3.1.2 and BRIDG version 3.0.3. Subsequent versions of the PRM Toolset will provide updated mappings and/or concepts as necessary to align with newer releases of both BRIDG and SDTM.

The Study Outline document requires Microsoft Word version 2007 or above, and is not yet available for the Apple MacIntosh OS.

Next Steps

The CDISC PRM Toolset is intended to be part of an evolving set of tools which maintain consistency and adherence to the related CDISC standards. Among future offerings planned are the web-based CDISC PRM Wizard tool which will allow users to enter their study concepts through an intuitive web page interface, and then produce output files such as the study SDTM Trial Summary Domain Dataset and an ODM XML file containing the study concept information. The ODM may then be transformed for XML-based submissions to trial registries and data repositories.

The core principle guiding the Toolset evolution is to provide a means to implement the use of the PRM standard for not only the Study Outline, but the Clinical Protocol in its entirety. The CDISC PRG team has intentionally restricted the scope of the initial release to allow users to gain easy, early exposure to the PRM, and ensure we are aligned with industry needs and able to accommodate feedback as the Toolsets are deployed.

The ADaM Examples in Commonly Used Statistical Analysis Methods provides examples of the Analysis Data Model applied in statistical methods that are commonly used. The ADaM  subject-level analysis dataset (ADSL) and Basic Data Structure (BDS) and the associated metadata are illustrated. Issues and points to consider when building ADaM datasets and metadata are highlighted. 

Please provide any comments by November 18, 2011.

Download ADaM General Examples Draft Document Package

You can download the standard as separate elements:

• ODM 1.3.1.xsd
• ODM 1.3.1 Final.html
• ODM 1.3.1 Foundation.xsd
• Read Me.txt
• xlink.xsd
• xml.xsd
• xmldsig core schema.xsd

The ODM v1.3.1 is also contained in the following zip file:

The ADaM team is working on several additional documents:

• Specifications for an ADAE dataset supporting analysis of incidence of adverse events.  ADAE may be the first example of a more general structure supporting analysis of incidence data, such as concomitant medications, medical history, etc.
• Detailed specifications for and examples of applying the Basic Data Structure (BDS) to time-to-event analysis.
• Examples with data and metadata of using the BDS for analyses such as analysis of covariance.
• Detailed description of the ADaM metadata model and its implementation.
• A document defining ADaM compliance.

These documents may be released for comment as separate documents.  Most of them are ultimately expected to be incorporated into future releases of the Analysis Data Model and ADaM Implementation Guide.

CDISC SHARE – Project Overview Document is Now Available

The CDISC SHARE Project Overview Document is intended as summary to orient CDISC members to the project background and progress made to date. This document was compiled by the SHARE project team and describes the project, the organization, stakeholders and provides a high-level description of the SHARE-based therapeutic area standards development process that is currently under development to support semantic interoperability. The document also describes the work of the five CDISC SHARE sub-teams, followed by a brief list of high-level software requirements, a section that describes how SHARE content has been developed to date, a summary of governance procedures, and finally a reference section that points to the various documents generated to support the project.

THE SHARE Project Overview document can be downloaded here.

CDISC SHARE RFI Now Available

CDISC is issuing a Request for Information (RFI) to identify potential collaborators for its proposed SHARE Global Metadata Repository.  SHARE is envisioned to eventually house comprehensive, well defined metadata and value sets for all CDISC standards from protocol through analysis, linking research concepts to healthcare, and will become the fundamental technology platform for developing, maintaining and accessing CDISC standards in the future.
 
This RFI describes in broad terms the scope and major functions of SHARE, and asks respondents to reply to a short list of questions to describe their organization, desired role and suggested ideas and potential product solutions to support the SHARE initiative.
 
If you are interested in replying to the RFI, please send an email with your organization name, contact person, phone and email to SHARE@cdisc.org.  All responses are due by Thursday, 20 September 2012.

CDISC Shared Health And Clinical Research Electronic Library

What is CDISC SHARE?
CDISC SHARE is a global, accessible electronic library, which through advanced technology, enables standardized data element definitions and richer metadata that can be used in software applications and research studies to improve biomedical research and its link with healthcare. SHARE metadata is envisioned to help find, understand and use clinical metadata efficiently.

In its first phase, CDISC SHARE will contain the CDISC standards CDASH and SDTM, providing machine readable elements (variables) within those standards. This will allow a range of software applications used within organizations to automatically access those definitions.

Later phases will include the remaining CDISC standards and also allow for the development of new therapeutic area domains and definitions along with the associated terminology.

CDISC intends to partner with other organizations to ensure that the SHARE content supports the vision of ‘enter once for multiple purposes’, including biomedical research and related areas such as public health, quality and safety.

Why develop CDISC SHARE?
CDISC SHARE will provide for easier access to the existing CDISC standards and any subsequent development to those standards. In particular, it will allow organizations to access the expansion of the CDASH and SDTM standards, as new therapeutic area domains are developed. By having this managed centrally and available electronically, it will decrease costs for those using the standards.

The CDISC SHARE environment will also provide for a consistent approach to standards definition and metadata development. This will in turn increase the quality of the standards by allowing for unambiguous definitions to be defined once but used many times in a consistent and integrated fashion across all of the standards as needed.

This will give users easier access – and software applications machine readable access – to the one “gold” data standard that will facilitate greater data re-use and aggregation. In time the definitions will be linked to those used within healthcare to permit the alignment of Clinical Research and Healthcare.

Who is involved in developing CDISC SHARE?

CDISC is working with the CDISC teams and stakeholders to develop the content for CDISC SHARE. CDISC is currently looking for partners to support the technology development for CDISC SHARE.

When will CDISC SHARE be ready?
We anticipate that CDISC SHARE will be ready for initial implementation in 2012. Updates to this projected timeline will be posted as they become available.

How do I get involved with CDISC SHARE?

You can volunteer to contribute content by becoming involved with one of the CDISC SHARE teams: Content, Governance, or User Interface. You can contribute financial support by becoming a member or giving a donation. You could become one of our key collaborators. Use CDISC SHARE when it is available and make sure that your partner companies do so too. 

Please see below for details on current Therapeutic Area Standards available for comment or initial use. And see our monthly technical updates, eNewsletter, social media as well as our Press Releases for regular progress updates.

Click Here for a Summary Table of All Available Therapeutic Area Standards

CFAST Therapeutic Area Standards Program

CFAST List of Planned Therapeutic Area Projects

The CFAST Program Steering Committee has released a prioritized list of therapeutic area data standards projects planned for 2013. Detailed descriptions of each project will be described in project charters after the project scoping and planning is completed. This list will be updated periodically as individual project schedules change and new projects are identified and resourced.

The Coalition for the Advancement of Standards and Therapies (CFAST), a joint initiative of CDISC and the Critical Path Institute, has established a program to develop therapeutic area standards along with FDA and TransCelerate Biopharma, Inc. which is governed by a program steering committee.

CFAST Program Steering Committee Charter

The steering committee meets every two weeks. Highlights and Decisions of CFAST Steering Committee Meetings are updated quarterly to summarize meetings from the previous quarter. The current document represents the period September-December 2012.

CFAST Program Steering Committee Meeting Highlights and Decisions

CDISC Polycystic Kidney Disease Therapeutic Area User Guide v1.0 – Now Available

CDISC together with the Critical Path Institute’s Polycystic Kidney Disease (PKD) Consortium (http://www.c-path.org/PKD.cfm)  is pleased to announce Version 1.0 of the Polycystic Kidney Disease (PKD) Therapeutic Area User Guide, a provisional standard that provides guidance on the implementation of the Study Data Tabulation Model (SDTM) to represent PKD data in regulatory submissions. This user guide, when used with the SDTMIG, is intended to guide the organization, structure, and format of standard PKD clinical trial tabulation datasets submitted to a regulatory authority such as the US Food and Drug Administration (FDA).

A CDISC provisional release is defined as a proposed standard that has completed a public review within the CDISC user community and is available for initial use; but subject to modification for some component parts still in process. Any revisions to the draft or provisional domains and their publication status will be updated as needed in future versions of the PKD User Guide.

The PKD User Guide also describes how the PKD Common Data Elements align to existing SDTM standard, provisional and draft domains.  

Follow this link to download the zip file for the PKD v1.0 Standards package.

Parkinson’s Disease Therapeutic Area User Guide v1.0 – Now Available

The National Institute for Neurological Disorders and Stroke (NINDS) and CDISC are pleased to announce that Version 1.0 of the Parkinson’s Disease (PD) Therapeutic Area User Guide is now available as a provisional standard to provide guidance on the implementation of the Study Data Tabulation Model (SDTM) to represent PD data in regulatory submissions. This user guide, when used with the SDTMIG, is intended to guide the organization, structure, and format of standard PD clinical trial tabulation datasets submitted to a regulatory authority such as the US Food and Drug Administration (FDA).

A CDISC provisional release is defined as a proposed standard that has completed a public review within the CDISC user community and is available for initial use; but subject to modification for some component parts (such as a new SDTM domain) that are still in process. Any revisions to the draft or provisional domains and their publication status will be updated as needed in future versions of the PD User Guide.

The PD User Guide provides background on the PD standards along with specific implementations for NINDS PD CRFs in existing SDTM standard, provisional and draft domains.

Follow the link to download the zip file for the PD v1.0 Standards package.

Virology Therapeutic Area Data Standards User Guide v.1.0 – Now Available

The Virology Therapeutic Area Data Standards User Guide v. 1.0 (VR-UG) is now available as a provisional standard to provide guidance on the implementation of the Study Data Tabulation Model (SDTM) to represent virology data in regulatory submissions. Follow the link.

CDISC Pain Therapeutic Area Standards Now Available

CDISC, together with the Analgesic Clinical Trial Translations Innovations, Opportunities, and Networks (ACTTION) (http://www.acttion.org) group, is releasing v1.0 of the Pain Therapeutic Area Supplement to the Study Data Tabulation Model User Guide. This supplement, when used with the SDTMIG, is intended to guide the organization, structure, and format of standard pain clinical trial tabulation datasets submitted to a regulatory authority such as the US Food and Drug Administration (FDA).

The CDISC Pain Data Standards v1.0 package is being released for provisional use, since it depends on the approval of terminology submitted to the Controlled Terminology team and represents significant changes from the draft version posted for comment earlier this year. The package consists of a User Guide, 19 Questionnaire Supplements and 13 SDTM annotated CRFs. (CRFs are not included for 3 CRFs due to lack of permission from authors and 3 CRFs in the public domain.) The User Guide provides the background on the standards along with the specific Pain implementations of the Medical History domain, Questionnaire domain and Findings About domain.

Additionally, the package contains two documents that were generated as a result of the public comment period. The first is a high level summary of the major differences between the draft user guide and the final user guide. The second is a spreadsheet that contains all of the comments that were submitted during the review period with responses from the PAIN data modeling team. Controlled terminology relevant to this PAIN User Guide is being been prepared through the CDISC Terminology Team and will be released as part of terminology package 12.

Download a zip file containing the complete Pain Therapeutic Area Standards Package.

CDISC Tuberculosis Therapeutic Area User Guide Released

The Critical Path to TB Drug Regimens (CPTR) and the CDISC SDS team is releasing v1.0 of the Tuberculosis Therapeutic Area Supplement to the Study Data Tabulation Model User Guide. This supplement, when used with the SDTMIG, is intended to guide the organization, structure, and format of standard tuberculosis clinical trial tabulation datasets submitted to a regulatory authority such as the US Food and Drug Administration (FDA).

The TB package is being released for provisional use, since it also includes four separate SDTM draft domains that are important for tuberculosis including: Device in Use (DU), Morphology (MO), Microscopic Findings (MI), and Skin Response (SR). Draft Domains are proposed standards that have been circulated for discussion in the CDISC user community but have not yet been included in a formal release of the SDTMIG, and thus may undergo further changes before being finalized. These draft domains will be released for public comment separately by the SDS team and incorporated in a future release of the SDTMIG, and are included here to provide context for users. Additionally, the package contains two documents that were generated as a result of the public comment period. The first is a high level summary of the difference between the draft user guide and the final user guide. The second is a spreadsheet that contains all of the comments that were submitted during the review period with responses from the TB data modeling team. Controlled terminology relevant to this TB User Guide has also been prepared through the CDISC Terminology Team and will be released as part of terminology package 11.  Access the TB User Guide here.

Study Design in XML Version 1.0

The CDISC Study Design Model in XML (SDM-XML) standard, version 1.0, has been released.  The specification document is available for download as a PDF file.  A ZIP file containing the XML Schemas, several examples, and an SDM-XML element and attribute reference also is available.

SDM-XML allows organizations to provide rigorous, machine-readable, interchangeable descriptions of the designs of their clinical studies. As an extension to the existing CDISC Operational Data Model (ODM) specification, SDM-XML affords implementers the ease of leveraging existing ODM concepts and re-using existing ODM definitions. SDM-XML defines three key sub-modules – Structure, Workflow, and Timing – permitting various levels of detail in any representation of a clinical study’s design, while allowing a high degree of authoring flexibility.

SDM-XML Version 1.0

Supporting Schemas, Examples, and References 

The Clinical Data Interchange Standards Consortium (CDISC), Health Level Seven (HL7), the U.S. Food and Drug Administration (FDA) and the U.S. National Cancer Institute (NCI) are pleased to announce the release of version 3.2 of the Biomedical Research Integrated Domain Group (BRIDG) model of the semantics of protocol-driven clinical research. Release 3.2 of the model is available for download at: http://bridgmodel.nci.nih.gov/download_model.

For a description of the changes in the BRIDG R3.2, please follow the link.  

Call for Subject Matter Experts

The Need:  The BRIDG Semantic Coordination Committee (SCC) works under the guidance of the BRIDG Board of Directors (BoD) to bring new semantics into the BRIDG Model by working with project teams to harmonize their models into BRIDG.  Project teams often bring subject matter experts into this process to help clarify the domain view of the concepts.  However, sometimes project-level subject matter experts are unavailable, or an issue comes up after the project is complete and the team has disbanded, or a BRIDG user submits a feature request that needs vetting by the community.  This often leaves the SCC with no subject matter experts with whom to discuss domain semantics.

The Solution:  To meet this need, the BRIDG SCC is starting an informal group of domain experts with various areas of expertise to whom we could direct questions on an as-needed basis.  The areas of expertise that we seek include, but are not limited to, the following:

• Clinicians,
• Biostatisticians,
• Clinical Research Associates (CRAs),
• Research Nurses,
• Data Managers,
• Protocol Writers,
• Protocol Coordinators,
• Regulatory Compliance Officers, and
• FDA Reviewers.   

We will only contact members of this group who have the expertise related to the subject in question and the members don’t need experience in modeling.  We will usually limit the interaction to email, with occasional conference calls if warranted by the complexity of the problem or the diversity of opinions expressed in email.  We may occasionally ask the experts to reach into their network of colleagues to find answers or build consensus. .  The time commitment is not expected to exceed 5 hours per month, often less, and would be on a volunteer basis.  We ask for a 1 or 2 year commitment and will rotate membership in the group to prevent burn-out, to spread the opportunity to participate among many individuals, and to ensure that we have “fresh eyes” coming into the group on a regular basis.

Your Part:  If you are interested in participating in this group, please send an email to bridgTHC-L@list.nih.gov with the following information:

• Name,
• E-mail,
• Phone Number,
• Area(s) of Expertise,
• Affiliation (i.e. name of agency, hospital, pharma company, etc.).

Participation in this group will give you the opportunity to influence the BRIDG model and the satisfaction of knowing your area of expertise will be accurately represented.

Background

The Biomedical Research Integrated Domain Group (BRIDG) Model is a domain analysis model representing protocol-driven biomedical/clinical research. It was developed to provide an overarching model that could readily be understood by domain experts and would provide the basis for harmonization among standards within the clinical research domain and between biomedical/clinical research and healthcare.

Three important streams of development have been brought together into this collaborative framework:

• CDISC – In 2003, CDISC started constructing a Domain Analysis Model to support harmonization of their models as well as with HL7.
• NCI – In 2004, the NCI's caBIG initiative joined the CDISC BRIDG efforts to construct a structured protocol representation and to achieve interoperability among clinical trials research in cancer
• In early 2005, the BRIDG model was been adopted by the HL7 RCRIM Technical Committee as the RCRIM Domain Analysis Model and is being implemented at NCI.

The model emerged from an unprecedented collaborative effort among clinical trial experts from CDISC, the US National Institutes of Health (NIH)/National Cancer Institute (NCI), the Food and Drug Administration (FDA), Health Level Seven (HL7), and other volunteers. The modeling effort is using the HL7 Development Framework (HDF).

This structured information model is being used to support development of data interchange standards and technology solutions that will enable harmonization between the biomedical/clinical research and healthcare arenas.

The BRIDG Model serves to bridge standards, as well as organizations and various communities, including academic research institutions and pharmaceutical product development organizations and related service and technology providers. It is also bridging the gap between clinical research and healthcare.

SDTM V1.2 & SDTM IG V3.1.2

&

The ADaM Implementation Guide, Version 1.0 (ADaMIG v1.0)

CDISC Healthcare Link Profiles Information

The CDISC Healthcare Link Initiative is one of the most rapidly developing areas of work being conducted by CDISC. Leveraging standards to improve the methods by which investigative sites can conduct medical research and capture data for clinical research studies is vital for a number of reasons; one very important reason is that clinicians frequently do one research study and no more due to the unwieldy nature of clinical research processes today. The increasing presence of an electronic health record (EHR) at healthcare sites opens new opportunities to integrate the processes of clinical care and clinical research. This will, in turn, expand the capacity for research and increase patient participation.

The overarching goals for CDISC Healthcare Link have been to:

• Make it easier for physicians to conduct clinical research,
• Collect data only once in an industry standard format for multiple downstream uses
• Improve data quality and patient safety

Since the CDISC Healthcare Link Initiative was conceived in ~ 1997 and officially launched in 2004, CDISC has developed: a suite of foundational standards (detailed in other chapters), various means to leverage these standards and a series of ‘enablers’ to improve the workflow of clinicians doing research. The Initiative has taken steps to ensure that the link between clinical research and healthcare takes into account existing regulations, privacy and security concerns, and current practices to provide practical pathways to achieve the vision through a stepwise approach. These enablers were developed in conjunctions with EHR vendors, and respect the limited amount of resource that these vendors can devote to a problem that is secondary to their main concern. These enablers are available now and have already proven to significantly decrease the time and effort to provide data for certain use cases, such as safety reporting, using EHRs.

Please click here to see a table listing the CDISC-IHE Healthcare Link profiles.

Click here to see the CDISC Healthcare Link Chapter (updated from the previously published CDISC Primer).

For information on other CDISC enabling standards used with Healthcare Link see CDISC CDASH, Protocol Representation Model, Study Design Model-XML and ODM.

Challenge: Interoperability between Healthcare and Clinical Research

For years now, researchers have dreamed of accessing the data held within electronic health records (EHRs) and using it for research purposes. And site investigators, who provide the data, have dreamed of a solution that eliminates double data entry of research data.

The CDISC Healthcare Link project began in 2005 and focuses on the mission of interoperability between healthcare (the EHR) and clinical research.  The roots of the Healthcare Link project come from the collaborative work of a preceding initiative-- the eSDI project, an FDA-CDISC project to encourage the use of eSource data (e.g. EHRs) in regulated clinical research, leveraging CDISC standards.

Solution: Integration Standards to connect disparate systems and data

The solution is here. CDISC and IHE (Integrating the Healthcare Enterprise) have created the inaugural working link between EHRs and clinical research systems. This groundbreaking approach uses the CDISC/IHE  developed integration profile,  Retrieve Form for Data-capture profile (RFD), along with CDISC standards to collect relevant data from the electronic health record for critical secondary uses such as Safety Reporting (and Biosurveillance), Clinical Research, and Disease Registries.  Reaching through to the EHR in this way to pull key data of interest to clinical research that is already existing in the EHR creates system interoperability and improves data quality and most importantly timeliness of data sharing (key in safety reporting) while alleviating the Investigator site from supporting and entering data in to multiple redundant (from the investigator’s perspective) data collection tools for the purpose of the secondary uses.
This integration creates the first ‘sticky parts’ that connect healthcare and clinical research data workflow. 

IHE Retrieve Form for Data Capture Profile

Case Studies

RFD has also been useful in debunking both the overly facile illusions of turnkey access to EHR data, and the overly pessimistic view that such access is twenty years off.

The case study work completed thus far by the Healthlink Initiative falls into two primary areas: interoperability demonstrations and production pilot implementations. We anticipate that the efforts made thus far by the Healthcare link Initiative will provide a foundation for the harmonization of standards between EHRs and clinical research-- and will support a new value case that was prioritized through an ANSI workgroup recently convened for this purpose.

Interoperability Demonstrations
RFD has been through a number of live Interoperability demos at HIMSS07, HIMSS08, CDISC International Interchange and most recently at the 2009 DIA Annual in San Diego.

HIMSS Flyer 2007

HIMSS Flyer 2008

DIA Flyer 2009

CDISC received a letter of endorsement from EHRA (the Electronic Health Record Association) in 2008 for the development work with IHE and the resulting RDF integration profile.

Contact

For information or inquiries, please contact CDISC Healthcare Link Program Manager, Landen Bain.  

Standard for Exchange of Nonclinical Data

ANNOUNCING - SEND Implementation Guide V3.0!

The CDISC SEND Team is pleased to announce the release of the SEND Implementation Guide (IG) Version 3.0.

The SENDIG is intended to guide the organization, structure, and format of standard nonclinical tabulation datasets for interchange between organizations such as sponsors and CROs and for submission to the US Food and Drug Administration (FDA).

Version 3.0 of the SENDIG in now the production version and is designed to support single-dose general toxicology, repeat-dose general toxicology, and carcinogenicity studies.  The SENDIG is based upon and should be used in close concert with Version 1.2 of the CDISC Study Tabulation Model (SDTM).

SENDIGv3.zip contains the IG in .pdf format.

Download SENDIGv3.zip here!

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The following links are useful to SEND users.

Documents referenced in the SEND Implementation Guide:

Case Report Tabulation Data Definition Specification

CDISC

CDISC Glossary

Define.xml specification

ISO 8601 Standards

NCI Thesaurus

SEND Controlled Terminology

SDTM (Study Data Tabulation Model)

SDTMIG Version 3.1.2

Study Data Specifications [FDA Electronic Common Technical Document (eCTD) - Study Data Specifications]

UNII

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Questions? Comments?

The CDISC SEND Team is always interested in your comments or questions.  Any feedback regarding SEND can be submitted to the CDISC SEND Team via email address: review@cdisc.org or by contacting any member of the CDISC organization.

CDASH SAE Draft Standard is now Available for Public Review and Comment – Comments due June 5, 2013

The draft CDASH-SAE document is now available for public review. The draft CDASH Serious Adverse Event Addendum to CDASH version 1.1 expands the current Adverse Event (AE) domain to include data elements for the capture of serious adverse event information in an SAE Form and, when indicated, will also allow for the generation of an E2B message for reporting an Individual Case Safety Report (ICSR) to Health Authorities.

FOR REVIEWERS:

We ask you to review the draft document and record your comments using the public review comment tool on the CDISC website. The link below will take you to the public commenting tool and a list of documents, please choose the CDASH-SAE doc from the list and begin to record your comments. 

Follow this link to get to the list of documents for review and select “CDASH SAE Addendum Draft 07May2013”, then go to the public comment tracker to record your comments

Click here for instructions on how to use the public review commenting tool.

Please return comments no later than June 5, 2013.

CDASH Version 1.1 was developed via CDISC’s consensus-based standards development process (see COP-001), which included comments from organizations in all three ICH regions (US, Europe and Japan).  The standard describes the basic recommended data collection fields for 18 domains; these include common header fields, demographic, adverse events, and other safety domains that are common to all therapeutic areas and phases of clinical research.   In addition, CDASH V 1.1 includes implementation guidelines and best practice recommendations, regulatory references and other information on the CDASH project. 

Download CDASH here:

CDISC Member download (CDASH) Standard version 1.1  |  Non-Member download (CDASH) Standard version 1.1  

CDASH User Guide

The CDASH User Guide (CDASH UG) is now available to CDISC members.  The CDISC UG provides CDASH implementation examples, including CDASH to SDTM mappings, CDASH ODM files and a library of example CRFs that have been created in several different data collection systems, including paper examples.  The CDASH team plans to update the CDASH UG with additional examples as they become available.

CDISC Members can download the CDASH User Guide here:

Version 1.0 of the User Guide for the Clinical Data Acquisition Standards Harmonization (CDASH) Standard version 1.1 

CDASH Team Projects

• CDASH Version 1.2

 The CDASH team is currently working towards the publication of CDASH Version 1.2.  This version will include minor updates and clarifications.  We anticipate that this new version will be available in Q4 2013.

 In addition, the CDASH Team has been working on a number of related and collaborative projects that include the development of new domains and associated documents for medical devices and therapeutic area CRFs.  Following are short summaries about these CDISC projects: 

• CDISC Device Standard 

 The CDISC Device team is comprised of members from the CDASH and SDS team and is working to develop the basic collection fields and the submission variables and mappings to support a majority of device studies. The Device team recently published draft SDTM constructs for public comment.  Work on the collection aspects will commence as soon as the submission elements are agreed. 

• CDISC Therapeutic Area CRFs

The CDASH team is collaborating with other CDISC teams to develop therapeutic area (TA) specific CRFs to be used together with the safety CRFs described in the CDASH standard.  Draft TA specific CRFs will be released for public review according to the CDISC consensus process. 

• CDASH Serious Adverse Event Domain 

This CDASH-E2B sub team is working to identify and describe the E2B basic data fields that are collected from investigative sites.  This new Serious Event domain is intended to reduce the need for separate SAE reporting processes and the inevitable duplication of data collection that occurs between the SAE and clinical databases.  The draft standard will be released for public review according to the CDISC consensus process. 

• REDCap CDASH-CRFs

The CDASH team also supports the development and review of a REDCap CDASH CRF library.  

• CDASH User Guide team 

The CDASH User Guide team will continue to add example CRFs and other implementation tools to the CDASH User Guide.

Join us on the CDASH Team!

If you would like to volunteer on the CDASH team, follow this link to let us know how you can help.  See below for more information about team participation.

CDASH Team Participation:

CDASH Team members should be experienced/familiar with the standard and/or knowledgeable about the collection of clinical data in the research area either from the investigative site or the CRO/Sponsor perspective.  Team members are expected to contribute meaningfully to the ongoing development of the standard. 

As a CDASH Team member you would be committing to:

• Attend scheduled teleconferences and actively participate in the discussions 

• Actively review CDASH documents in development and provide written and verbal feedback 

• Actively review internal and external review comments with the CDASH Team

• Participate in the development of new and update of existing CDASH documents, including helping to identify new domains and aligning development with other standards teams

As a CDASH Team member you would also have the opportunity to do one or more of the following:

• Lead sub-teams of volunteers to accomplish time-bound goals 

• Contribute to the development of training materials 

• Attend periodic face-to-face CDASH Team meetings to participate in development and review activities 

• Attend periodic cross-team CDISC meetings to work with other standards teams 

• Liaise with other standards development teams

Other Opportunities for Participation:

Should you be unable to meet the level of commitment required of team membership, the CDASH team still needs you!  

The other main venues for participation in the CDASH project as a non-Team member are:

• Reviewing draft standards and documents during public review and providing written feedback 

• Implementers of the CDASH standard are encouraged to send feedback to Katie Carothers or Rhonda Facile.  Information on implementation experience will be used to continue to improve the CDASH standard and other related standards.      

• Encouraging your company to become a CDISC member

• Participating in the CDASH discussions on the CDISC website

• Participating in Linked In and other forum discussions to help clarify and refine the standards & implementation guides

• Attend CDISC events (e.g., Interchanges, webinars on CDASH)

Please follow this link to let us know what you would like to do and we will get you set up with what you need to participate.  

Update 12 April 2013

SDTM, SEND, Questionnaire, and Clinical Data Element Glossary Controlled Terminology files have been updated on NCI EVS. The dates of the new files are 2013-04-12. These terminology files replace all older SDTM, SEND, Questionnaire, and Clinical Data Element Glossary terminology files and include terms from Review Package 13. There are approximately 198 new questionnaire terms and 134 terms across the three additional files.

The Questionnaire Controlled Terminology file dated 2013-04-12 has the following questionnaires deleted because no copyright permissions were received: MMSE, EQ-5D-5L, EQ-5D-3L, SF36 v1.0 STANDARD, SF36 v1.0 ACUTE, SF36 v2.0 STANDARD, and SF36 v2.0 ACUTE.

CDSIC approved controlled terminology is maintained and distributed as part of NCI Thesaurus and is available for direct download from the CDISC website on an NCI File Transfer Protocol (FTP) site in Excel, text, odm.xml, pdf and html formats at the following web-link.

New requests or changes to existing terminology can be accessed through the New Term Request Page via the link to CDISC Controlled Terminology below. Scroll down to the last paragraph.

CDISC Controlled Terminology

___________________________________________________________________________________________

Please post any comments, questions or suggestions to CDISC’s Public Discussion Forum.

___________________________________________________________________________________________

Terminology Call for Public Review Package 14 - Comments Due by 12 April 2013

CDISC Controlled Terminology Package 14 is ready for public review. The public review package consists of 8 spreadsheets one each for:

• Laboratory Tests
• Units of Measure
• Specimen Type
• ECG
• PK
• General – These terms include codelists that do not fall into any of the other groups
• Devices
• SEND

Use this link to register/login to the Tracker so you can access the review documents.

CDISC will be using the Public Comment Tracker on the CDISC Portal for this review. Click here for directions on how to access and use the Public Comment Tracker Tool.

Detailed information on using the tracker can be also be found via “Help” after clicking on Public Comment Tracker.

Overview

What is the Protocol Representation Model, and how does it affect the success of a clinical study? As we will see in this article, the Protocol Representation Model, or PRM, is of great importance, not only to data managers and statisticians, but to individuals and entities across the realm of clinical research: from the clinician, to the medical writer, to the study coordinator, to federal agencies, and eventually and most importantly, to the patient. The PRM was developed to a) support the generation of a protocol document, b) to support research study (clinical trial) registration and tracking, c) to support regulatory needs, and d) facilitate single-sourced, downstream electronic consumption of the protocol content. This article offers background information on the history of the Protocol Representation Model and generation of PRM V 1.0, recent developments in the model, use cases for the PRM describing the business value of the PRM, description of a new Toolkit made available to users of the PRM and anticipated future progress in this area.

The Clinical Research Study Protocol

As researchers know, the protocol, in terms of a clinical research study, is the plan, or blueprint, that describes the study’s objectives, methodology, statistical considerations, and the organization of the study. Much in the way that an effective business plan lays out the foundation for what is expected in beginning a successful enterprise, a well-designed protocol is the map that is vital to the overall success of a clinical trial or study. Everyone involved in the research study needs the protocol; this includes but is not limited to the investigator, the site personnel, the clinical project managers and monitors, the data managers, and the statisticians. Additionally, the protocol is a requirement by regulatory authorities for regulated clinical research studies. A fully developed clinical protocol is essential for regulatory purposes including Investigational New Drug (IND) applications, Institutional Review Boards (IRB) and Ethics Committees. Follow the link.

CDISC PRM Toolset Version 1.0

The CDISC Protocol Representation Group is pleased to announce the availability of Version 1.0 of the CDISC Protocol Representation Model (PRM) Toolset.

The purpose of the PRM Toolset is to provide an evolving set of tools to assist organizations in implementing the use of the CDISC PRM V1.0 standard. This first release provides two tools: the Study Outline Document Template and the Study Outline Concepts List.

1.  Study Outline Document Template

The intended use of this tool is to provide organizations a starting point for standardizing the Study Outline document within their respective organization. Conceptually, the CDISC template is to be considered the minimum set of suggested concepts.

2.  Study Outline Concepts List

The intended use of this tool is to provide organizations a detailed mapping between the Study Outline Concepts, BRIDG, and the SDTM Trial Summary Domain and to serve as a reference which includes further explanation of the concepts and any related notes.

See the link at the bottom of the page for the PRM Toolset Version 1.0

CDISC Protocol Representation Model

The ADaM team is proud to release Version 1.2 of the ADaM Validation Checks. All changes and updates are described in Appendix 2.

Some checks have been reworded for clarification. In addition, 61 new checks have been added to cover rules not previously addressed.

The additional checks cover these general categories:

1. Corollaries to existing checks
2. Set of checks for *CAT* variables (e.g. BASECAT, PARCATy)
3. Checks for the use of “y” in a variable name for incremental ordering
4. Presence and population of PARAM and PARAMCD in BDS datasets
5. Need to have a minimum of AVAL or AVALC in BDS datasets
6. Comparison of data values between SDTM.DM and ADSL 7) Set of checks for TRT* sequence and grouping variables

** CDISC ADaM Basic Data Structure for Time-to-Event Analyses **

The ADaM team is pleased to release the final version 1.0 of the ADaM Basic Data Structure for Time-to-Event (TTE) Analyses. This document provides definitions and examples of the datasets, variables, and metadata that support general TTE analyses. The three scenarios covered by the document are 1) A Single Endpoint with a Binary Value for Censoring, 2) A Single Endpoint with Multiple Values for Censoring, and 3) Composite Endpoints. There are descriptions of typical analyses that are performed in a Time-to-Event Analysis, including example outputs and associated Results-Level metadata. The document also provides clear step-by-step information about how to create and populate the supportive and analyzed datasets and variables required for Time-to-Event Analysis and full traceability. Follow the link.

** CDISC ADaM Basic Data Structure for Adverse Event Analysis **

The ADaM team is pleased to release the final version 1.0 of theThe Adverse Event Analysis Document (ADAE). This document is based on the CDISC Analysis Data Model: Version 2.1 and Implementation Guide v1.0 documents. The AE structure presented in this document is built on the nomenclature of the Study Data Tabulation Model Implementation Guide (SDTMIG) V3.1.2 standard for collected data, and has added attributes, variables, and data structures required for statistical analyses. The document presents metadata defined for the ADAE dataset. There are also several example display layouts and examples of the data and associated metadata that support the examples. Follow the link.

ADaM Examples in Commonly Used Statistical Analysis Methods

The ADaM Examples in Commonly Used Statistical Analysis Methods provides examples of the Analysis Data Model applied in statistical methods that are commonly used. The ADaM subject-level analysis dataset (ADSL) and Basic Data Structure (BDS) and the associated metadata are illustrated. Issues and points to consider when building ADaM datasets and metadata are highlighted.

Download ADaM Examples Final Document

The CDISC LAB Base Model Version 1.0.1 has been released to industry for implementation. The last update incorporated changes to model specifications to address minor bugs and to harmonize with CDISC's Operational Data Model and Submissions Data Standards Model. As of April 2004, the CDISC LAB Team released the final XML schema representation of the model for implementation. In addition, sample datasets were provided to further illustrate the use of the Lab Model.

The Microbiology Extension is under review by the LAB team. Comments on the draft microbiology and ECG extensions as well as any comments on LAB Model Version 1.0.1 (Base and XML Schema) can be submitted via the CDISC Discussion Forum. The Lab Model files are described below.

• LabModelReleaseNotes (pdf) Description of this release.
• LabModel.zip Zip file of all files in this relase

The following files document the Base model Version V1.0.1 and are being posted for implementation:

• Lab1-0-1-Specification (pdf) The Lab Model V1.0.1. specification in pdf format
• Lab1-0-2-BaseDataFields.xls The Lab Base Model V1.0.2 data fields in Excel spreadsheet format
• Lab1-0-1-ReferenceRanges.xls The Lab Model V1.0.1 reference ranges in Excel spreadsheet format
• LabReviewBaseSampleData.dat Base model sample data for use with SAS and ASCII

The following files document the XML schema implementation of the Base model and are posted as final versions for implementation:

• Lab1-0-1-BaseSchema.xsd Base model XML schema
• Lab1-0-1-Base.doc Text outline for the base model XML schema
• Lab1-0-1-BaseSampleData.xml Base model sample data in XML format

The following files document the Microbiology Extension and are posted as drafts for comment:

• LabReviewMicroDataFields.xls The Lab Microbiology extension data fields in Excel spreadsheet format
• LabReviewMicroSchema.xsd Microbiology extension XML schema
• LabReviewMicro.doc Text outline for the microbiology extension xml schema
• LabReviewMicroSampleData.xml (Currently Unavailable) Microbiology extension sample data in XML format
• LabReviewMicroSampleData.dat Microbiology extension sample data for use with SAS and ASCII

The following files document the ECG Extension and are posted as drafts for comment.

• LabReviewECGSpecification.xls The Lab Model ECG review version specification in pdf format
• LabReviewECGDataFields.xls The Lab Microbiology extension data fields in Excel spreadsheet format

The following files document the Reference Range Model and are posted as drafts for comment.

• Lab1-0-1RefRangeDefinition.xls An Excel spreadsheet with the basic definition of the model
• Lab1-0-1RefRangeSpecification.pdf A PDF document with a more complete description of the model
• Lab1-0-1RefRangeSchema.xsd The XML schema for the model
• Lab1-0-1RefRangeSchema Documentation.doc A Word document with the model and documentation for the XML schema
• Lab1-0-1RefRangeSampleData.xml An XML file with sample data
• Lab1-0-1RefRangeSampleData.txt An ASCII file with the same sample data as in the XML file
• Lab1-0-1RefRangeSampleData.xpt A SAS transport data set with the same sample data as in the XML and ASCII files
• LabRefRange1-0-1.zip A zip file that contains the 7 Reference Range documents in this review release.

The following file contains a template for reporting a Case Study to the Lab team:

• LabModelCaseStudyTemplate.doc Template for reporting case studies to the LAB team.

CDISC Common LOINC Tests

• CDISCCommonLOINCTests.doc This table is a subset of the LOINC® database terms that have been identified by 3 central laboratories as the most frequently used terms in clinical trials. The document also contains further instructions for accessing LOINC.

The CDISC XML Technologies team is pleased to announce the release of the Define-XML 2.0 specification. Define-XML 2.0 is a major revision of the Define-XML standard for transmission of metadata for SDTM, SEND and ADaM datasets. The model has been extensively refined in response to implementation experience with Version 1.0, evolution of the SDTM, SEND and ADaM standards and best practices by SDTM and ADaM metadata experts.

Key changes to the model include:

• Support for CDISC Controlled Terminology
• Flexible definition of Value Level metadata
• Enhanced documentation of data origin or source
• Improved handling of comments.

Please read the PDF document ReadMe first. This document provides information about he organization of the release package and other important notes.

Use this link to download the Define-XML 2.0 release package.

Use this link to view the XML Technologies team responses to comments received during the draft comment period: Public comment dispositions

XML Schema Validation for Define.xml White Paper

The XML Schema Validation for Define.xml white paper provides guidance on validating define.xml version 1.0 documents against the define.xml XML schemas.  It proposes practices and tools to improve define.xml schema validation. The goal is to foster more consistent validation results in order to facilitate regulatory submissions and interchange of define.xml documents. The document does not include any define.xml specifications or recommendations for creating define.xml content.

XML Schema Validation for Define.xml (pdf)

This zip file packages 3 define.xml version 1.0 examples with copies of the schemas for testing define.xml validation.

Define.xml Validation (zip)

FDA Adds CDISC ODM Define.xml to Study Data Specifications

The FDA has now included the CDISC Case Report Tabulation Data Definition Specification (define.xml), which is based on the CDISC ODM, as part of the eCTD Study Data Specifications for the eCTD for submissions using the SDTM. The revised specifications are available here.

Case Report Tabulation Data Definition Specification

(CRT-DDS, also called define.xml)
Final Version 1.0

CRT-DDS Released for Implementation February 10, 2005.

The CDISC define.xml Team has published the Case Report Tabulation Data Definition Specification (define.xml) Version 1.0 for implementation, which supersedes all prior versions. Version 1.0 reflects changes from a comment period through the Health Level 7 (HL7) Regulated Clinical Research Information Management Technical Committee (RCRIM) in December 2003 (www.hl7.org) and CDISC's website in September 2004 as well as the work done by the define.xml team in conjunction with the CDISC ODM team to add functionality, features, and additional documentation.

This document specifies the standard for providing Case Report Tabulations Data Definitions in an XML format for submission to regulatory authorities (e.g., FDA). The XML schema used to define the expected structure for these XML files is based on an extension to the CDISC Operational Data Model (ODM).

The 1999 FDA electronic submission (eSub) guidance and the electronic Common Technical Document (eCTD) documents specify that a document describing the content and structure of the included data should be provided within a submission. This document is known as the Data Definition Document (e.g., "define.pdf" in the 1999 guidance). The Data Definition Document provides a list of the datasets included in the submission along with a detailed description of the contents of each dataset. To increase the level of automation and improve the efficiency of the Regulatory Review process, define.xml can be used to provide the Data Definition Document in a machine-readable format.

Please post any comments, questions or suggestions to CDISC's Public Discussion Forum.

• CRT DDSpecification 1-0-0 (pdf) Case Report Tabulation Definition Specification (define.xml), Version 1.0
• define1-0-0.xsd The define.xml schema version 1.0. This schema 'glues' the extensions and the ODM together to create the full define.xml definition. Applications implementing define.xml should reference only the define1-0-0.xsd directly.
• define-extension.xsd This schema defines where in the ODM the define.xml extensions should appear.
• define-ns.xsd This schema defines where in the ODM the define.xml extensions should appear.
• SchemaFiles.zip A ZIP file that includes all of the schema related files only (define1-0-0.xsd, define-extensions.xsd and define-ns.xsd).
• define1-0-0.xsl An initial define.xml style sheet (Version 1.0).
• Example 1: define.xml An example of the data definition document in XML without a style sheet reference.
• Example 2: define.xml An example of the data definition document in XML with a style sheet reference.
• ExampleFiles.zip A ZIP file that includes both examples, including all referenced external files for the 2nd define.xml example (e.g., define1-0-0.xsl, sample SAS Version 5 Transport Files, blankcrf.pdf and supplementaldatadefinitions.pdf).
• CRT DataDefinitionFiles.zip A ZIP file that contains all of the files referenced above (excluding the above zip files)

To ensure the latest copy of the define.xml specifications and supporting materials, users should:

1. Check the CDISC website for news related to new versions of the define.xml specifications, style sheet or support documentation.
2. Compare the website posting date with their file download date and update when necessary.

CDISC has an active ODM certification program. For full details and to see those companies that have achieved certification click here.

There are several versions of the model including the latests release of ODM v1.3.1.

All previous versions of ODM can be found by using this link

Medical Device Supplement to the Study Data Tabulation Model v.1.0 – Now Available

The Medical Device Supplement to the Study Data Tabulation Model (SDTMIG-MD) v.1.0 is now available. This standard defines recommended standards for the submission of data from clinical trials in which medical devices are used. The document includes seven new domains, developed by a team comprised of medical device experts, CDISC experts, and the FDA (CDRH and CBER), and represents years of work by the members of the CDISC Medical Device team. Training on these seven new domains has been incorporated into the standard SDTM training available through CDISC. Follow the link.

CDISC Study Data Tabulation Model (SDTM) v1.3 and Study Data Tabulation Model Implementation Guide (SDTMIG) v3.1.3 final documents released

The CDISC SDS Team is pleased to announce the release SDTM v1.3 and SDTMIG v3.1.3. The updates to these documents include:

• The addition of new variables to the general observation classes for both human clinical trials and SEND;
• The incorporation of the content previously published in the SDTM Amendment 1; 
• Changes to the Trial design section;
• Document formatting updates;
• Inclusion of the domains developed as the Oncology Disease-specific Therapeutic Area Supplement.

IMPORTANT: Please read the PDF document “How to Use SDTMIG 3.1.3” first. This document provides information of the SDTMIG 3.1.3 documentation package and, as the title implies, how to use it.

Follow the link to download the zip file containing the Documentation package.

A spreadsheet including all metadata tables from SDTM v1.3 and SDTMIG v3.1.3 is now available in the Member's Only area.