/ 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
  1. Sponsoring Group(s)

RCRIM Technical Committee
  1. 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.
  1. Project Dependencies:

This project is dependent on CDISC projects completing their domain analysis modeling and harmonizing these models into the BRIDG.
  1. Project Objectives:

Determine the number of message(s)/projects that will include the 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 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 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. 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. / Date of completion is unknown. We first need to determine how many messages will be created based on our needs as described.
  1. Project Status and Dates:

Initiated
Approved by Sponsor
Reviewed by PMO
Approved
Amended
  1. 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. / Create new standard
Revise current standard
Supplement to a current standard
Withdraw current standard
Collaboration Efforts
Collaborating with / MOU Status[1] / Nature of MOU[2] / Comments[3]
CDISC / 2001; renewed 2004 / CDISC and HL7 have MOU– formed RCRIM TC through relationship / Includes agreement to harmonize standards, Outreach Committee, exchange of representation on Boards/Advisory Boards

CDISCContentProjectHL7RCRIMProjectDescriptionV2.doc Last Updated: 6/1/2006 Page 1 of 5

[1] 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.