Health Level Seven®, Inc.
Project Scope Statement
1. Project Name and ID:
CDISC Content to Message Exploratory Project
A project ID will be assigned
by the PMO
2. Sponsoring Group(s)
RCRIM Technical Committee
3. Project Scope:
The project scope is to explore the creation of HL7 V3 message(s) from existing content
within the CDISC standard. This project will specifically include a) study summary (clinical trial
registry), b) eligibility criteria, c) trial design (including parts I and II: arms, elements visits,
planned assessments, and planned intervention(s)), d) statistical analysis plan, e) collected
data/study data tabulations and f) derived data/analysis datasets, all of which are currently
defined by the CDISC standard. The use case for this project is sending the aforementioned
content to a regulatory authority to support a regulatory submission.
Both CDISC and RCRIM use the BRIDG domain analysis model. CDISC will be in charge of
the content and business requirements and harmonization of the components of the CDISC
standard into the BRIDG model. This project will be responsible for mapping the relevant
BRIDG model sections to the RIM (DMIM) and to determine how many messages/projects
need to be created. The deliverables of this project is a DMIM and a recommendation on how
to move forward with other projects.
Although the message creation (RMIM) is not in scope for this project, the intention to create
messages for the aforementioned content.
4. Project Dependencies:
This project is dependent on CDISC projects completing their
domain analysis modeling and harmonizing these models into the
BRIDG.
5. Project Objectives:
Determine the number of message(s)/projects that will include the Date of completion is
unknown. We first need to
following components comprising the CDISC Standard.
a) Study Summary (Clinical Trial Registry):
Utilize the applicable elements of the Protocol Representation
Group’s Clinical Trial Registry (CTR) model, which will be
harmonized with the BRIDG. These elements define the protocol
and include the WHO trial registry elements. Standard, agreed-to
terminology must also be incorporated. Creating terminology is out
106752820
Last Updated: 6/1/2006
determine how many
messages will be created
based on our needs as
described.
Page 1 of 5
Health Level Seven®, Inc.
Project Scope Statement
of scope for this project. A standard set of study
summary/registration elements will enable companies to more
readily electronically exchange and communicate information
about the protocol, when it is developed, with various parties, e.g.
FDA and other regulatory agencies, WHO, development partners,
potential subjects for the research. These elements can be used
to track trial progress once the study has begun enrolment. This
project will create a structured representation of the applicable
elements from CTR and SDTM Study Summary.
b) Eligibility Criteria (EC):
Using the Trial Design Model Team and Protocol Representation
Group’s EC model, create a structured representation of a core set
of encoded protocol eligibility criteria, using accepted medical
terminology and vocabulary standards. Through uniform coding of
such a core set of eligibility criteria it will be possible to facilitate
more rapid efficient screening of potential participants for available
clinical trials worldwide, thereby speeding the discovery of new
interventions to treat, prevent or screen for disease among
patients. Coded eligibility criteria also will provide semantic
interoperability (the exchange of content and meaning) among
systems and stakeholders, serve as the underpinning for various
technical implementations for subject screening and recruitment,
facilitate electronic protocol authoring, and standardize the core
eligibility components of protocol registration across all trials. Work
is currently in progress to structure the Eligibility Criteria through
the Trial Design Model and the Clinical Trial Registry (Protocol
Representation Group and CDISC TDM team). The structured EC
will be modeled into the BRIDG.
c) Trial Design:
The CDISC TDM team will complete the CDISC and Protocol
Representation modeling of protocol Trial Design, Parts I and II,
and harmonization of these into the BRIDG. Using this BRIDG
representation of Trial Design, this project will develop a structure
to describe Trial Design Part I: Arms, Epochs, Elements, and Trial
Design Part II: Planned Assessments, and Interventions that are
planned to allow the trial to answer the scientific question(s) posed
by the trial. The time a subject participates in the trial is divided
into Epochs, time periods during which different experimental
treatments, or preparation for or follow-up of treatment, are
applied. During an Epoch in which treatments are applied,
subjects may be divided into groups which receive different
treatments. Time periods during which these different treatments
106752820
Last Updated: 6/1/2006
Page 2 of 5
Health Level Seven®, Inc.
Project Scope Statement
are applied, or of preparation for or follow-up after treatment, are
called Elements. Arms are "paths" a subject may take through the
trial.
An Arm can be seen as a sequence of Elements.
Comparisons between groups of subjects assigned to different
Arms are used to address the scientific questions posed by the
trial. The Planned Assessments and Planned Interventions (time
and events table) provides a means to compare what was planned
in a study compared to what was actually done (the results/data).
This information can also drive/define the development of the case
report forms for collecting the results.
d) Statistical Analysis Plan (SAP):
Using the BRIDG representation of a structured SAP, create a
structured representation of the aspects of statistical analysis plan
that are relevant to the trial design/protocol and to interpretation of
the analyses that are done with the results. The initial target will
be statistical analysis planning and delivery for regulated clinical
research, including, relationship of conducted analyses to planned
analyses, and rationale for differences and representation of
analysis artefacts (analysis results and displays thereof). The
Protocol Representation Group is in the process of defining a
structured SAP and modeling this into BRIDG.
e) Study Data Collection:
Create a structure that defines study data that are to be submitted
as part of a product application to a regulatory authority (study
data tabulations from case report forms). Data tabulation datasets
are one of four ways to represent the human subject Case Report
Tabulation (CRT) and equivalent animal data submitted to the
FDA. One benefit to industry of submitting data tabulation datasets
that conform to the standard structure is that it minimizes the need
to submit the same data in multiple formats. One benefit to the
regulators is to provide regulatory reviewers with a clear
understanding of the datasets provided in a submission by
communicating clear descriptions of the structure, purpose,
attributes, and contents of each dataset. Such a standard format
also enables the use of standard review tools and the population
of a cross-study database. The CDISC Study Data Tabulation
Model (SDTM) defines the standard format for such data and it
has been modeled into the BRIDG.
f) Derived Data and Analysis Datasets
Using the BRIDG representation of the CDISC ADaM and
define.xml, this project will create an appropriate structure.
106752820
Last Updated: 6/1/2006
Page 3 of 5
Health Level Seven®, Inc.
Project Scope Statement
Certain derived data may be submitted along with study
tabulations.
Also, analysis datasets developed through the
statistical analyses of the results (following the Statistical Analysis
Plan) should be produced and submitted to regulatory reviewers.
The CDISC Analysis Dataset Models (ADaM) have been
developed as standards for submission of such derived data and
analyses.
Because ADaM is an extension of SDTM and because the
linkages between the observed and derived data are critical, this
project will also include in its structure the requirements met by
define.xml. Define.xml provides the working integration of SDTM
and ADaM as a single data model. It also provides the
transparency for the reviewer for flags, imputations, source code,
metadata, analysis files, and derivations performed by the
sponsor.
6. Project Status and Dates:
Initiated
Approved by Sponsor
Reviewed by PMO
Approved
Amended
7. Project Intent, Categorization and Collaboration (for HISB)
The mission of ANSI Healthcare Informatics Standards Board (HISB) is to provide
an environment that facilitates, coordinates and harmonizes national and
international healthcare informatics standards.
The following represents some minimal information needed to assist in that effort.
Project Intent
CDISC is an open, multidisciplinary, non-profit organization that has
established worldwide industry standards to support the electronic
acquisition, exchange, submission and archiving of clinical trials data and
metadata for medical and biopharmaceutical product development. The
mission of CDISC is to develop and support global, platform-independent
data standards that enable information system interoperability to improve
medical research and related areas of healthcare. CDISC also has a
formal relationship with HL7; CDISC initiated the HL7 Clinical Trial SIG,
which has become the HL7 RCRIM Technical Committee and has a
CDISC representative as co-chair of RCRIM.
106752820
Last Updated: 6/1/2006
Create new standard
Revise current standard
Supplement to a current standard
Withdraw current standard
Page 4 of 5
Health Level Seven®, Inc.
Project Scope Statement
Collaboration Efforts
Collaborating with
CDISC
1
MOU Status1
Nature of MOU2
2001;
renewed
2004
CDISC and HL7 have
MOU– formed RCRIM TC
through relationship
Comments3
Includes agreement to harmonize
standards, Outreach Committee, exchange
of representation on Boards/Advisory
Boards
Memorandum of Understanding (MOU) Status types are: Negotiating or Signed (please indicate the date signed.) Leave blank if there is
no MOU in place. Refer to http://www.hl7.org/about/agreements.cfm for a current listing of HL7’s MOU agreements.
2 Indicate the nature of the MOU, e.g., agreement for reciprocal meeting rights, joint meetings, etc.
3 Use this cell to document failed collaboration attempts.
106752820
Last Updated: 6/1/2006
Page 5 of 5