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Ressources Deliverables Working Groups


The PhUSE CSS Working Groups bring together academia, industry, technology providers and the FDA to collaborate on projects to address unmet computational science needs. This dashboard provides a single point of reference for active working groups and projects that are part of the PhUSE CSS Collaboration. The content developed by the PhUSE CSS Working Group Projects can be accessed via the PhUSE CSS Deliverables Catalog.

Have a look at the latest CSS Working Groups Achievements here.

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Working Groups

The development and adoption of data standards over the last decade has shown significant promise in improving efficiencies in the product submission and review process. However, there have also been gaps, issues and challenges in the interpretation and use of the standards. This group will identify specific gaps preventing FDA and industry from optimizing the use of standards and collaborate to close those gaps.


Traceability and Data Flow: Discuss and define traceability considerations and best practices for study-level and integrated dataset conversions for different data flow scenarios.


Analysis Data Reviewer's Guide (ADRG): Althoug ADaM provides a robus metadata framework, FDA Reviewers benefit from additional, human-readable, documentation of analysis methods, data sets, and programs that cannot be fully explained within the ADaM metadata. The development of an Analysis Data Reviewer's Guide (ADRF) template will ensure this documentation is provided to the agency in consistent and usable format.


(NEW) Best Practices for DataStandards Implementation: Identify ambiguities within CDISC documentation and draft best practice documentation for handling these ambiguities .


(NEW) Study Data Standardization Plan (SDSP): Development of a recommended study data standardization plan early in the development cycle to optimize implementation of CDISC SEND, SDTM, ADaM data standards is the focus of this new project. This is a new project and the Wiki page is currently under development


New project coming soon!

With the development and implementation of industry data standards, there is a great opportunity to develop standard reporting across industry and to support the needs of FDA medical and statistical reviewers. This working group will identify potential standard scripts for data transformations and analyses across an within therapeutic areas. The goal will be to begin the process of standardizing analyses across the industry, but also include examples of what can be done with a standardized data set.


Identification of Existing Scripts: Identifying scripts/tools/programs for data transformation, analysis, and reporting in the public domain and negotiating with the owners to bring said scripts/tools/programs into the PhUSE Code Repository (Repository)


Qualification Steps for Scripts in the Repository: Define minimum standards by which a script/tool/program included in the Repository can be considered validated and define the processes for validation.


Maintain and Enhance Repository: Establish the basic structure and management of the Repository.


Legal Ownership and Issues in an Open Source Repository: Examine the legal issues relating to open source repositories including code ownership and make recommendations for the Repository.


Templates and Metadata for Documenting Scripts and Coding Practices: Create templates for documenting shared scripts including requirement specifications, design documents, user guides, and release notes.


Working Group Communications: Develop and execute a communications plan for the Development of Standard Scripts for Analysis and Programming Working Group.


Display and Analysis White Papers: Development of white papers to provide recommended Tables, Figures, and Listings for clinical study reports and integrated summary documents.

This emerging technologies working group will be an open, transparent forum for sharing pre-competitive means of applying new technologies and is being challenged with creation of well-defined collaborative projects that will describe, prioritize, assess, and assist advancement of these opportunities. Possible topics include (but are not limited to) semantic web applications, analysis metadata, modeling, simulation, and “The Cloud”.


Metadata Management, Common Metadata Definitions: Develop common definitions regarding metadata (e.g. operational metadata, structural metadata, etc.).


Lowering the Barriers to Adoption of Cloud Technology: Differentiate actual barriers from perceived barriers to the adoption of cloud-based solutions by publishing use cases, best practices and decisions trees.


This workgroup will investigate how W3C semantic standards can support the clinical and non-clinical trial data life cycle from protocol to submission including the representation of CDISC Foundational Standards in RDF, modeling analysis results, and representing a protocol in RDF.


Representing CDISC Protocol Representation Model (PRM) in RDF: Represent the concepts in the PRM in RDF including elements related to a schedule of events and activities, a study’s experimental design, subject eligibility, and clinical trial registry.


Representing CDISC Validation Rules in RDF: Represent SEND, SDTM, and ADaM validation rules in RDF and link the validation rules to the CDISC standards represented in RDF.


(NEW) Modeling Analysis Results Metadata to Support Clinical and Non-Clinical Applications: Development of standard models and technical standards for the storage and usage of analysis results data and metadata to support clinical and non-clinical applications.


(NEW) keyCRF: Creation of a semantically annotated eCRF that enables the pre-popluation of the eCRF from linked data elements in an EHR summary and HL7’s Continuity of Care Document.


There is a need to improve nonclinical assessment and regulatory science by identifying key needs and challenges in the field and then establish an innovative framework for addressing them in a collaborative manner. The group created a framework for moving certain projects forward to support nonclinical informatics efforts and to develop specific implementation solutions and SEND.


Nonclinical Standardization Roadmap Team: Identify best practices for the implementation of nonclinical standards, prioritize standardization of nonclinical data types, and compile a list of key standards resources.
(NEW) Developing a "How to Design a Custom Domain" resource and running a pilot with unmodeled data.


NICE (Nonclinical Data Interconnectivity for Clinical Endpoint predictivity): Utilizing Information on drug labels to derive useful conclusions and clinical/nonclinical outcomes by pharmacologic class


Nonclinical Historical Controls: Collaboration between industry, academia, and regulatory agencies to identify projects related to historical control data and better ways to utilize historical control data.


Interorganizational SEND (I-SEND): Identify challenges and propose solutions to help Sponsors and CROs implementing SEND collaborate more efficiently.


SEND Implementation User Group: Provide a forum for users implementing SEND to ask questions and share knowledge.


Nonclinical Study Data Reviewers Guide: Build a Nonclinical SDRG work package.


(NEW) Nonclinical Source System Providers Engagement and Education: Facilitate greater participation of data system vendors in development and implementation of data standards through onboarding tools. (Wiki page to be created)


(NEW) Emerging Technologies Collaboration: Explore opportunities to support alignment between SEND and SDTM. (Wiki page to be created)


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Optimizing WG

!! Emerging Technologies

The development and adoption of data standards over the last decade has shown significant promise in improving efficiencies in the product submission and review process. However, there have also been gaps, issues and challenges in the interpretation and use of the standards. This group will identify specific gaps preventing FDA and industry from optimizing the use of standards and collaborate to close those gaps.

This emerging technologies working group will be an open, transparent forum for sharing pre-competitive means of applying new technologies and is being challenged with creation of well-defined collaborative projects that will describe, prioritize, assess, and assist advancement of these opportunities. Possible topics include (but are not limited to) semantic web applications, analysis metadata, modeling, simulation, and “The Cloud”.

Traceability and Data Flow : Discuss and define traceability considerations and best practices for study-level and integrated dataset conversions for different data flow scenarios.


Analysis Data Reviewer's Guide (ADRG) : Althoug ADaM provides a robus metadata framework, FDA Reviewers benefit from additional, human-readable, documentation of analysis methods, data sets, and programs that cannot be fully explained within the ADaM metadata. The development of an Analysis Data Reviewer's Guide (ADRF) template will ensure this documentation is provided to the agency in consistent and usable format.


(NEW) Best Practices for DataStandards Implementation: Identify ambiguities within CDISC documentation and draft best practice documentation for handling these ambiguities .


New project coming soon!

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Optimizing WG

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Emerging WG

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FDA comments are an informal communication and represent the individual's best judgment. These comments do not bind or obligate FDA. The contents of this wiki are from the individual contributors and do not necessarily reflect the view and/or policies of the Food and Drug Administration, the employers of the individuals involved or any of their staff.