What
CDISC standards are ready to implement?
The CDISC standards that are ready to implement,
i.e. are in production release, are all open
and free on the CDISC website. They include:
Study Data Tabulation Model (SDTM)
- The
current version is 3.1.1. There is a lengthy
Implementation Guide with instructions and
examples of how to implement.
Standard for the Exchange of Non-Clinical
Data (SEND) –
The current version is 2.3; this is actually
considered to be a part of the SDTM (for animal/tox
data vs. human data)
Operational Data Model (ODM) –
The
current version is 1.2.1. Version
1.3 Draft is currently posted for comment.
This version will enhance v 1.2 such that
it can support SDTM metadata for regulatory
submission.
Laboratory Data Model (LAB) –
The current version is 1.0.1. This content
standard can be implemented via ASCII, SAS,
XML or and ANSI-accredited HL7 V3 message.
Case Report Tabulation Data Definition
Specification (CRT-DDS) Define.xml –
The
current version is 1.0. This is a means
to submit SDTM metadata to FDA in an ODM XML
format.
SDTM
and define.xml are referenced as specifications
for FDA Guidance.
All of the CDISC standards are on the website
under ‘Standards”. They are free
of charge and openly accessible. CDISC is
committed to making future enhancements and
versions backwardly compatible.
Will
the CDISC SDTM be mandated by the US Food
and Drug Administration?
There is a “Proposed Rule” that is being considered now by the US Department of Health and Human Services (HHS) to amend the regulations that govern the format for submission of clinical study data and bioequivalence data in NDAs, BLAs, ANDAs and their supplements and amendments to FDA. This would require that these data be submitted in electronic format and that standardized data structures, terminology and code sets in FDA Guidance (i.e. SDTM developed by CDISC) be used ‘to allow for more efficient and comprehensive data review’. The date when this Proposed Rule will become a Rule/regulation is currently not known. Please see this link for additional information and links to relevant Federal documentation http://www.cdisc.org/publications/fda.html.
There are statements that have been made (and withdrawal of three FDA Guidances – see the website above for details) indicating that, as of 1 January 2008, only the eCTD format will be acceptable for eSubmissions. However, the CDISC SDTM will still be a preferred but not required data specification until the proposed rule is approved.
What
is the CDISC Technical Roadmap?
The CDISC Technical Roadmap
is the 2-3 year plan to merge CDISC standards
into a single standard where the format is
XML-based (ODM); the content is defined by
SDTM, LAB, SEND, ADaM, and the Protocol; the
terminology/vocabulary is the output from
the CDISC Terminology group. The majority
of the standards will be merged and mapped
into the BRIDG model by the end of 2006. The
Protocol will take longer because it is not
yet a production standard.
What
is the relationship between CDISC and Health
Level Seven (HL7)?
CDISC has an Associate Charter
Agreement with HL7 that was originally signed
in 2001 and was renewed in 2004. The renewed
agreement includes reciprocal organizational
memberships and reciprocal advisory board
positions, in addition to educational and
financial opportunities and benefits for organizations
that become members of both organizations.
In addition, the renewed Charter included
the formation of an Outreach Committee for
Clinical Research (OCCR). This committee,
which is comprised of members from FDA, CDISC,
HL7, NIH and other groups involved in clinical
research, was appointed by the Board of HL7
to strategically represent the domain of clinical
research within the context of HL7 and to
reach out to the clinical research community
to encourage harmonized standards development.
What
is the relationship between CDISC and FDA?
FDA's official position
is that of "observer" when involved
in CDISC activities. FDA representatives participate
as liaisons on CDISC teams, present at CDISC
conferences, present at other industry conference
on the need for (CDISC) standards, and have
publicly endorsed CDISC activities. CDISC
and FDA are working on a CRADA where CDISC
would train FDA folks on the standards as
well as how to process that data once it arrives
at FDA. CDISC is specifically named in the
Critical Path Opportunities List for developing
standards to streamline clinical trials. FDA/DHHS
have publicly endorsed the SDTM, with awards
going to the SDS team, and CDISC standards
are listed as specifications in FDA Guidance
(see prior question).
What
are benefits of the CDISC standards?
Ultimately all benefits
associated with standards implementation ---
efficiency, time saving, process improvement,
reduced time for regulatory submissions, more
efficient regulatory reviews of submission,
savings in time and money on data transfers
among business partners, more efficient archive
and recovery procedures, more accessible information,
better communications amongst team members
--- come down to saving money - whether it
be in time, resources or actual funds.
Gartner estimates that, if the biopharmaceutical
industry were to implement CDISC standards
and electronic data interchange, over $6 billion
would be reaped overall. A more robust and
detailed business case for standards for individual
organizations is in the process of being developed.
Preliminary results will be available as of
June 2006 and more detailed reports will follow.
What
is the CDISC IP Policy? Why does CDISC have
such a policy?
The CDISC Intellectual Property
(IP) Policy is designed to facilitate the
activities of CDISC in developing open standards,
to maximize the adoption of such standards
by protecting against the ownership of the
standards by one party and to protect the
legitimate intellectual property rights of
contributor to the standards. In its role
of leading the development of standards, CDISC
must protect those standards to ensure that,
to the extent practicable, they remain neutral,
open, compensation (royalty)-free, and without
encumbering ties to prior intellectual property.
The
entire policy is posted on the CDISC website.
What
other policies does CDISC have?
The CDISC
Policies and Bylaws include, but are not
limited to:
- Code of Conduct and Professional Ethics
(which applies to anyone involved in CDISC
initiatives, especially team leaders and
User Network)
- Communication Policy (which applies to
anyone presenting on behalf of CDISC) –
presentations and publications, when made
available, are posted on the CDISC website)
- Board Committee Charters and Policies
Does
CDISC have a certification program?
As of April 2006 CDISC is
working towards a fully implemented certification
program which would "certify" that
an application is compliant with a certain
version of one or more CDISC standards. The
first such program will be for the CDISC Operational
Data Model (ODM). (Stay tuned for more
information on this topic soon.)
What
is a CDISC User Network? Who are they? Where
are they?
CDISC User Networks are
CDISC "user groups". They are folks,
usually in a certain geographic area, that
have organized themselves so that they can
share CDISC standards implementation experiences.
They are currently located in the following
areas:
USA
Europe
Japan
Why
do we put the CDISC Terminology in an NCI
Repository?
To provide a little more
context, CDISC’s relationship with NCI
EVS (Enterprise Vocabulary Services) is about
more than just delivering terminology through
their data repository, or caDSR (Cancer Data
Standards Repository). Through its working
relationship with NCI EVS, CDISC is able to
leverage existing services, expertise and
infrastructure designed specifically for development,
harmonization, delivery and support &
maintenance of controlled terminology. If
CDISC were to simply deliver terminology code
lists to our user community via Excel spreadsheets,
that is not “controlled” terminology.
NCI EVS staff works with the CDISC team to
develop controlled terminology from the code
lists CDISC provides. Via the NCI Thesaurus,
CDISC metadata and code list terms are broken
down and defined to the most basic atomic
unit. Then, everything is pieced back together
into Common Data Elements (CDEs) in the caDSR.
This detailed process allows CDISC and the
user community to maximize interoperability
and integration of information, moving CDISC
much further down the road toward its mission.
The CDEs constructed in the caDSR are represented
in the database repository using the ISO 11179
international standard for metadata registries.
The caDSR is comprised of various tools to
manage and deploy the CDEs. One such tool,
the CDE Browser, is the premier tool that
will be used by the user community. Via this
browser, all CDISC CDEs (and CDEs developed
for other organizations) are publicly accessible
and may be extracted in XML or Excel format
anywhere in the world. This is an incredibly
powerful environment, where each CDE is linked
back to synonyms, subconcepts, superconcepts,
roles, relationships, etc in the NCI Thesaurus
source vocabulary via a unique numeric identifier.
Therefore, a user may search for CDEs in both
the CDISC context and all other contexts.
In short, the caDSR is a set of tools and
a database to create, deploy and maintain
data elements in a standard environment. This
promotes metadata reuse and enables semantic
consistency across research domains.
Note: These tools and repositories are
completely open to anyone in the world who
can access the web.
What
is in the Members Area? Who has access to
the Members Area?
The "Members Area"
of the web site is an area to which only CDISC
members in good standing (membership fee has
been paid) have access. The purpose is to
provide added value to those who make CDISC
possible, since all of the CDISC standards
are open and free to anyone. The Members Area
contains tools such as the Excel spreadsheet
version of the SDTM domains, the Introduction
to CDISC course, the minutes from the Board
of Directors and Industry Advisory Board meetings.
In the future (later 2006), it will contain
a ‘proto-tool’ developed for the
FDA to view ODM electronic CRF data and audit
trail in a comprehensible format and also
case studies. Anyone who belongs to a Member
Company can have the access code.
To
get help implementing the CDISC standards,
what should one do?
Suggestions for obtaining
implementation assistance include, but are
not limited to:
What
is a Registered Solution Provider? What do
they do?
Registered Solution Providers
are those individuals and companies that claim
to have expertise in one or more CDISC standards.
The CDISC Production Standards Technical Coordinating
Committee has done a thorough review of each
Registered Solution Provider and have found
their claims to be valid. This is, in essence,
a recommended list of companies to help you
with CDISC standards implementation. When
the CDISC certification program is in place,
these companies can be certified; to date,
this certification of compliance has not been
available.
Are
there online training courses available?
As of April 2006 there are
no on-line CDISC training courses. However,
we are working to make this method of education
available. The first course should be available
in Q4 2006. CDISC public courses can be found
at http://www.cdisc.org/education/index.html.
Why
should my company join CDISC? What types of
organizations join CDISC?
Members include pharmaceutical
companies, including all of the top 30, Biotech
companies including Amgen; Genentech; etc,
Contract Research Organizations, Consulting
companies (Zurich Biostatistics; Assero, Ltd;
etc), Academic institutions, Government (NCI),
Technology Providers, and even an Institutional
Review Board (IRB);. See the CDISC
website for a complete list.
Any organization interested
in furthering the CDISC mission is welcome.
A complete list of member
benefits is available on the CDISC website.
By becoming a member organization of CDISC,
you will enable the work of the organization
to continue and influence this important work
that can and will change the direction of
the industry. Other benefits of CDISC membership
include access to standards development work/documentation
which is inside the members’ only area
of the website, discounts on CDISC education
courses, discount on membership dues for joint
CDISC and Health Level Seven (HL7) membership,
discounts on CDISC-sponsored events (e.g.,
annual interchanges), and the opportunity
to become a CDISC Registered Solutions Provider.
How
does CDISC spend its money?
Since CDISC is a virtual organization, there
is very little overhead. A full 70% of the
revenue (which comes primarily from membership
dues) is spent on standards development, education,
and board/IAB support. The remaining revenue
covers the company’s expenses and employee
salaries and benefits. Annual interchanges
are conducted at essentially a break-even
cost/income ratio.
In 2006, an updated strategic plan and organizational
structure was approved and moving forward,
CDISC will be supporting four main areas:
1) production standards, 2) implementation
services, and 3) innovation initiatives, and
4) global operations. To view the new organizational
structure, click
here.
What
should I do if I want to make a regulatory
submission to FDA using CDISC standards?
A process is currently being
developed and should be documented sometime
in 2006. In the meantime, please see the following:
It is recommended that you contact the new
FDA Office of Business Process Support if
you are considering making a regulatory submission
using CDISC standards. Gary
Gensinger is currently the main contact
for SDTM submissions.
How
can I get involved in CDISC?
- Your company can join CDISC - your monetary
contributions help support our ongoing efforts.
- You can provide a case study detailing
your implementation experience with one
or more CDISC standards. If you are willing
to do this, we will even provide someone
to interview you so that you don’t
have to write it up yourself. Please contact
Julie
Evans.
- You can join a User
Network.
- You can comment on standards posted for
comment.
- You can volunteer to join one of our
various project teams by sending your contact
information and information on your interests
and skill sets to Shirley
Williams.
How
does CDISC communicate with its members and
non-members?
CDISC distributes bi-monthly electronic newsletters
and other electronic messages to all those
interested in CDISC. CDISC maintains a database
of all its member organizations and anyone
who has expressed a desire to be kept informed
of the CDISC activities and opportunities.
CDISC keeps confidential all email addresses.
To get on the CDISC mailing list, click
here.
How
can we provide input to the CDISC standards?
The following avenues are available for providing
input to the CDISC standards:
- Review draft standards for comment and
provide feedback to the authoring team.
Draft standards can be found on the CDISC
website.
- Post suggestions to the CDISC public
Discussion Forum.
- Provide a case study detailing your implementation
experiences with one or more CDISC standards.
If you are willing to do this, we will even
provide someone to interview you so that
you don’t have to write it up yourself.
Please contact Julie
Evans.
- Participate on a CDISC project. Send an
e-mail to Shirley
Williams expressing your interest in
becoming involved in a project and any further
information that would permit an assessment
of opportunities that will fit your skill
set and interests.
- Join one of the many User Networks groups
and make your thoughts known.
Why should a company join CDISC?
- Show support for industry-wide clinical research standards that facilitate exchange of information among partners (e.g. biopharmaceutical companies, CROs, technology vendors, regulatory authorities).
- Gain access to the Members Area of the website. This area contains Case Studies, CDISC Business Case; Introduction to CDISC Course, access to CDISC Team minutes (the latest information on new standards in development as well as future releases of existing standards), and free access to tools (e.g. ODM viewer and more to come).
- Receive discounts for CDISC Educational Courses and Events (e.g. Interchanges in US, Europe, Japan and China 2008).
- Have direct influence on and input to the standards that are in development or those being enhanced. (See next question since Sponsors have more influence than Members.)
- Funding from the CDISC membership makes it possible for CDISC to fulfill its mission; it is an integral requirement to continue the development and maintenance of the CDISC standards for the global benefit of the biopharmaceutical industry and clinical research, in addition to supporting CDISC communication and implementation services.
Why become a Corporate Sponsor vs. a Corporate Member?
- Corporate Sponsors receive substantially greater discounts for CDISC Educational Courses and Events than do Members.
- Sponsors have a seat on the Industry Advisory Board. This Board has the following roles in CDIS
- Provide input into the CDISC Strategy (developed by the CDISC Board Strategy Committee).
- Provide input into the CDISC Technical Roadmap.
- Elect one representative from the IAB to the CDISC Board of Directors.
- Have two ex-officio members on the CDISC Board (IAB Chair and Chair-elect).
- Have IAB members on Board Committees (Strategy, Technical Advisory, Governance, and Financial Oversight).
- Recognition by your peers and regulators as an organization that is willing to financially support CDISC’s extremely valuable contribution to the betterment of the biopharmaceutical industry and biomedical/clinical research.
