CDISC is a non-profit standards development organization that aims to develop data standards for clinical research to enable data sharing and interoperability. It has developed several standards including SDTM for submission data, ODM for data exchange, and Define.xml for metadata. The standards are used by clinical research organizations, sponsors, investigators, and regulators to facilitate communication and archive of clinical data. CDISC is working on additional standards and initiatives to further its mission of improving medical research and healthcare through data standardization.
Cómo en oracle usamos bat (business analysis tool) para agregar valor camilo ...Vicky Watson
Por Néstor Camilo, Enterprise Architect Senior Manager, Oracle.
En II Jornadas de Innovación http://www.austral.edu.ar/ingenieria/2012/10/ii-jornadas-de-innovacion/
The document discusses a presentation given by AARNet to the CAUDIT Spring Meeting. The agenda includes an overview of AARNet's strategy and customer focus, services available on the network, and future service development. AARNet aims to deliver a high-performance network while adding value through collaboration, content delivery, and mobility applications and services. Customers have expressed interest in these types of services to better utilize the core network. AARNet considers factors like customer benefit, cost reduction, existing infrastructure use, and support longevity when prioritizing new service development.
Laurea University of Applied Sciences has multiple Living Labs focused on user-driven innovation through co-creation. Dr. Tuija Hirvikoski directs Laurea's Living Labs network, which includes over 25 physical and virtual Living Labs. The network collaborates internationally, including with the European Network of Living Labs and the Sendai-Finland Wellbeing Centre in Japan. Living Labs are tools for open research and development that engage users, citizens, and customers in innovation.
STABU Foundation is a not-for-profit organization established in 1976 to promote clear communication in the Dutch construction industry. It develops standardized specification systems to facilitate information exchange at all stages of construction projects. STABU's products include specifications, contracts, and knowledge databases that integrate information from industry organizations. It is located in Ede, Netherlands and works nationally and internationally to adopt and influence standards while offering customized solutions for regional implementation.
The 1st ISO IT Forum will be held from 29 November to 1 December 2011 in Geneva. The forum will discuss IT trends and standards, understand ISO's technology products and services, and provide feedback on IT priorities. The 29-30 November portion will include keynote speeches and sessions on ISO's strategic plan, XML, e-learning, and eCommittees. Optional training sessions will be held on 1 December. The forum aims to simplify, accelerate and improve processes through information technology.
eSource, DIA EuroMeeting, Lisbon, March 2005AsseroLtd
The eSDI Group was formed to address issues with collecting and using electronic patient-reported outcomes data in clinical trials. The group has been meeting regularly and developing a draft white paper. Key areas of focus include interim analysis, psychometric and system validation, and moving towards electronic data collection while maintaining regulatory compliance. Next steps include further revising the white paper and soliciting broader feedback to help provide guidance on electronic patient-reported outcomes.
The document discusses electronic source data (ESD) and the Retrieve Form for Data Capture (RFD) profile. It provides an overview of the RFD profile, which allows clinical data stored in electronic health records to be retrieved and used in clinical trials, registries, biosurveillance and other systems using open standards. Several scenarios are described where RFD could be used, such as a physician discovering an adverse drug event and summoning a form from the drug manufacturer to report it. The presentation demonstrates how RFD enables clinical data to be reused across different systems without re-entry.
Artificial intelligence (AI) is everywhere, promising self-driving cars, medical breakthroughs, and new ways of working. But how do you separate hype from reality? How can your company apply AI to solve real business problems?
Here’s what AI learnings your business should keep in mind for 2017.
Cómo en oracle usamos bat (business analysis tool) para agregar valor camilo ...Vicky Watson
Por Néstor Camilo, Enterprise Architect Senior Manager, Oracle.
En II Jornadas de Innovación http://www.austral.edu.ar/ingenieria/2012/10/ii-jornadas-de-innovacion/
The document discusses a presentation given by AARNet to the CAUDIT Spring Meeting. The agenda includes an overview of AARNet's strategy and customer focus, services available on the network, and future service development. AARNet aims to deliver a high-performance network while adding value through collaboration, content delivery, and mobility applications and services. Customers have expressed interest in these types of services to better utilize the core network. AARNet considers factors like customer benefit, cost reduction, existing infrastructure use, and support longevity when prioritizing new service development.
Laurea University of Applied Sciences has multiple Living Labs focused on user-driven innovation through co-creation. Dr. Tuija Hirvikoski directs Laurea's Living Labs network, which includes over 25 physical and virtual Living Labs. The network collaborates internationally, including with the European Network of Living Labs and the Sendai-Finland Wellbeing Centre in Japan. Living Labs are tools for open research and development that engage users, citizens, and customers in innovation.
STABU Foundation is a not-for-profit organization established in 1976 to promote clear communication in the Dutch construction industry. It develops standardized specification systems to facilitate information exchange at all stages of construction projects. STABU's products include specifications, contracts, and knowledge databases that integrate information from industry organizations. It is located in Ede, Netherlands and works nationally and internationally to adopt and influence standards while offering customized solutions for regional implementation.
The 1st ISO IT Forum will be held from 29 November to 1 December 2011 in Geneva. The forum will discuss IT trends and standards, understand ISO's technology products and services, and provide feedback on IT priorities. The 29-30 November portion will include keynote speeches and sessions on ISO's strategic plan, XML, e-learning, and eCommittees. Optional training sessions will be held on 1 December. The forum aims to simplify, accelerate and improve processes through information technology.
eSource, DIA EuroMeeting, Lisbon, March 2005AsseroLtd
The eSDI Group was formed to address issues with collecting and using electronic patient-reported outcomes data in clinical trials. The group has been meeting regularly and developing a draft white paper. Key areas of focus include interim analysis, psychometric and system validation, and moving towards electronic data collection while maintaining regulatory compliance. Next steps include further revising the white paper and soliciting broader feedback to help provide guidance on electronic patient-reported outcomes.
The document discusses electronic source data (ESD) and the Retrieve Form for Data Capture (RFD) profile. It provides an overview of the RFD profile, which allows clinical data stored in electronic health records to be retrieved and used in clinical trials, registries, biosurveillance and other systems using open standards. Several scenarios are described where RFD could be used, such as a physician discovering an adverse drug event and summoning a form from the drug manufacturer to report it. The presentation demonstrates how RFD enables clinical data to be reused across different systems without re-entry.
Artificial intelligence (AI) is everywhere, promising self-driving cars, medical breakthroughs, and new ways of working. But how do you separate hype from reality? How can your company apply AI to solve real business problems?
Here’s what AI learnings your business should keep in mind for 2017.
This three-day course is designed for engineers, scientists, project managers and other professionals who design, build, test or sell complex systems. Each topic is illustrated by real-world case studies discussed by experienced CONOPS and requirements professionals. Key topics are reinforced with small-team exercises. Over 200 pages of sample CONOPS (six) and templates are provided. Students outline CONOPS and build OpCons in class. Each student gets instructor’s slides; college-level textbook; ~250 pages of case studies, templates, checklists, technical writing tips, good and bad CONOPS; Hi-Resolution personalized Certificate of CONOPS Competency and class photo, opportunity to join US/Coalition CONOPS Community of Interest.
The document proposes expanding the scope of the Aldata Customer Association to represent the global Symphony EYC customer community following a merger between Aldata and EYC. It suggests enlarging the association's scope and representation to include the full Symphony EYC product set and interests of all customer communities. It also proposes maintaining the association's focus on collaboration and influence as an independent entity, enhancing the customer executive committee role, and responding to requests for more integrated global cooperation.
The document provides an overview of ArcelorMittal's self-awareness and development tool. It discusses how the tool aims to increase self-awareness through self-ratings and feedback to understand strengths and areas for development. The tool uses a personality and leadership style assessment to provide multi-source feedback to employees to help with personal development planning and is aligned with ArcelorMittal's values and competencies. The tool has been used by over 800 employees since its launch in 2008 and provides individual feedback sessions to help employees identify development objectives.
Learn about the Open Data Center Alliance Workgroups, Usage Models and Roadmap Structure from the perspective of the Alliance Technical Coordination Committee. This presentation was used in the Nov. 18, 2010 Alliance Webcast delivered by Howard Grodin, VP of Strategic Programs, Terrermark; Alliance Technical Coordination Committee Member, and Ravi Subranamiam, Intel Corporation; Alliance Technical Advisor.
For more information about the Open Data Center Alliance, visit www.opendatacenteralliance.org. You will also find the Webcast recording that accompanies this presentation there.
The document outlines the SIPs (Strategic Innovation Processes) process which includes four main phases: 1) Define & Discovery, 2) Design & Architecture, 3) Development & Execution, and 4) Roll Out. It also lists the roles involved in a project including founders, partners, team members, and users/stakeholders.
Enterprise Cloud Development and Agile Transformation Strategy - China 2012 Laszlo Szalvay
This is a seminar I gave throughout China the week of Oct 29th 2012. It covers the topics of Agile Software Development (Scrum, Lean, XP) and the new framework of Enterprise Cloud Development that CollabNet has been socializing. Please contact me for similar private talks at your company.
Stott & May is a boutique international search consultancy founded in 2009 and based in London specializing in finance, technology, IT, and infrastructure recruitment. The company has 50+ staff across offices in London and New York. It delivers permanent, contract, and interim recruitment services on a contingency, search, or retained basis. The senior management team includes Managing Director Stephen Stott, Chairman Laurence Rosen, and Giles Daniels who leads the permanent delivery practice and overall strategic development.
Using Six Sigma to Drive Tangible Service Desk Improvement and SavingsITSM Academy, Inc.
Kirk Holmes, itSMF USA National Capital President Emeritus, President of Holmes and Associates, will present his experience with using Sig Sigma to answer the question; How do you reduce Service Desk costs, improve quality, and fulfill the Service Desk mission?
The document summarizes a webinar hosted by the DASH7 Alliance on December 2, 2009. The webinar agenda included introductions to the DASH7 Alliance, an overview of the DASH7 technology, a case study by Evigia on their use of DASH7, and a discussion of DASH7 standardization and certification efforts. The DASH7 Alliance is a non-profit consortium advancing the use of DASH7 wireless sensor networking with over 30 global participants. Its goals include improving the DASH7 standard, certifying product compliance, educating the market, and encouraging new innovations.
Hundreds of DoD contractors and commercial organizations have adopted the Capability Maturity Model Integrated (CMMI). Their published results show improved cost and schedule performance. Despite these results, there is still community debate over the value of CMMI, and whether CMMI ratings provide sufficient guarantees of program performance. Much of the confusion results from: (1) inaccurate CMMI ratings; (2) over-estimating the benefits that CMMI provides a customer; and (3) contractors not living up to their CMMI rating. This program will explore each of these topics individually.
Does CMMI Benefit the Customer?
What are the true benefits of Level X – to the customer? This presentation will explore the issues, by examining the fundamental principles behind the model, from a customer perspective. Costs and benefits to the customer will be emphasized, focusing on the relationship of CMMI practices to productivity, predictability and speed, as well as the cost of implementing CMMI-compliant processes. Timelines for impacting program performance, and practical tips and techniques for realizing the benefits will be highlighted.
How High Maturity Projects Fail
Process maturity supposed helps project deliver predictably on-time and on-budget. Why then, have we had a string of project failures from supposedly mature organizations, even ones that have achieved high maturity (Levels 4 and 5)? The presentation will examine the reasons why projects failure, and their relationship to process maturity. Some failures are due to non-process effects -- people, products, and technology. Mature processes diminish some of these effects and amplifying others. Some of the failures are due to projects not using the assets and capabilities of a mature organization. This presentation will identify the needed assets and discuss critical project start-up activities.
How to Get Contractors to Live Up to Their CMMI Ratings
Like many sports stars and teams, it is possible to have tremendous capabilities, but not live up to those in practice. Similarly, project teams may fail to live up to the capabilities implied by their CMMI level. This presentation describes simple, but effective ways to ensure CMMI practices are used on a project, and provide measurable benefits to the customer. Methods presented are based on techniques used successful by Northrop Grumman Corporation to monitor and manage their key suppliers.
The document provides an overview of TUSC, an IT consulting company that was purchased by Rolta. It discusses TUSC's core service areas including Oracle applications and BI implementation. It also provides an overview of Piocon, an Oracle BI expert firm that was purchased by TUSC. The document then details several case studies of TUSC/Piocon's work with clients such as IPSCO, AM Castle, Chevron, and VCA Antech to implement Oracle BI solutions.
The document discusses Oracle's enterprise architecture tools and reference architecture. It outlines key enterprise architecture activities including architecture reviews and recommendations using TOGAF. It presents Oracle's enterprise reference architecture diagram depicting core systems, integration systems, and access channels supported by enterprise infrastructure and information management. The activities aim to create an enterprise IT platform through initiatives for master data management, flexibility, business insights, operational excellence, and agile/secure infrastructure.
IT Strategic Alliances is an IT consulting and staffing firm with global presence and over 30 years of experience. They offer specialized services tailored to clients' unique needs and goals. Their strategy is to provide tailored solutions through full project teams, responsibility for deliverables, or complete accountability. They have capabilities in areas like ERP implementation, testing, legacy systems, BI, and application maintenance through locations in North America and Europe. Partnering with them can help reduce costs, control spending, and increase shareholder value through proven methodologies and risk mitigation.
The document summarizes a workshop on applying federated authentication standards like SAML to the GEOSS system. It introduces the COBWEB project and its goals of integrating crowdsourced environmental data. The workshop covered previous work using SAML, related work in GEOSS, and COBWEB's initial plans to pilot federated authentication for accessing data from multiple sources. Attendees were encouraged to participate in future COBWEB authentication activities.
090602 Isto Overview And Conformity Assessment LefkinPeter Lefkin
The document provides an overview of the IEEE-ISTO (Institute of Electrical and Electronics Engineers - Industry Standards and Technology Organization). It discusses:
1. The background and history of IEEE-ISTO since 1999, including its affiliation with IEEE and role as a forum for consortia.
2. The synergies between IEEE-ISTO and IEEE-SA (Standards Association), allowing each organization to benefit and meet customer needs through complementary standards processes.
3. IEEE-ISTO's vision, mission, board of directors, current programs, and areas of expertise like program management, conformity assessment, and interoperability testing.
The document discusses challenges in the electronics industry due to economic recession, including companies reducing resources for standardization and laying off standards experts. This delays standards development and can increase costs across the supply chain. It also introduces NeoKinetics Inc. (NKI) which offers expert representation for standards development at various levels of engagement in order to help companies focus resources on core activities and lead in standardizing their intellectual property.
The document provides an overview of Fusion Applications, including:
1) Fusion Applications is a new generation of business applications built using Fusion Middleware that combines and optimizes existing Oracle applications like EBS along with improved usability and business processes.
2) It features a process-centric and intuitive user interface aligned with real-life business processes, embedded analytical dashboards, and integrated collaboration features.
3) Fusion Applications are built on a service-oriented architecture using ADF, SDO, BPEL, and other Fusion Middleware components to provide a flexible and customizable platform.
High-Quality IPTV Monthly Subscription for $15advik4387
Experience high-quality entertainment with our IPTV monthly subscription for just $15. Access a vast array of live TV channels, movies, and on-demand shows with crystal-clear streaming. Our reliable service ensures smooth, uninterrupted viewing at an unbeatable price. Perfect for those seeking premium content without breaking the bank. Start streaming today!
https://rb.gy/f409dk
This three-day course is designed for engineers, scientists, project managers and other professionals who design, build, test or sell complex systems. Each topic is illustrated by real-world case studies discussed by experienced CONOPS and requirements professionals. Key topics are reinforced with small-team exercises. Over 200 pages of sample CONOPS (six) and templates are provided. Students outline CONOPS and build OpCons in class. Each student gets instructor’s slides; college-level textbook; ~250 pages of case studies, templates, checklists, technical writing tips, good and bad CONOPS; Hi-Resolution personalized Certificate of CONOPS Competency and class photo, opportunity to join US/Coalition CONOPS Community of Interest.
The document proposes expanding the scope of the Aldata Customer Association to represent the global Symphony EYC customer community following a merger between Aldata and EYC. It suggests enlarging the association's scope and representation to include the full Symphony EYC product set and interests of all customer communities. It also proposes maintaining the association's focus on collaboration and influence as an independent entity, enhancing the customer executive committee role, and responding to requests for more integrated global cooperation.
The document provides an overview of ArcelorMittal's self-awareness and development tool. It discusses how the tool aims to increase self-awareness through self-ratings and feedback to understand strengths and areas for development. The tool uses a personality and leadership style assessment to provide multi-source feedback to employees to help with personal development planning and is aligned with ArcelorMittal's values and competencies. The tool has been used by over 800 employees since its launch in 2008 and provides individual feedback sessions to help employees identify development objectives.
Learn about the Open Data Center Alliance Workgroups, Usage Models and Roadmap Structure from the perspective of the Alliance Technical Coordination Committee. This presentation was used in the Nov. 18, 2010 Alliance Webcast delivered by Howard Grodin, VP of Strategic Programs, Terrermark; Alliance Technical Coordination Committee Member, and Ravi Subranamiam, Intel Corporation; Alliance Technical Advisor.
For more information about the Open Data Center Alliance, visit www.opendatacenteralliance.org. You will also find the Webcast recording that accompanies this presentation there.
The document outlines the SIPs (Strategic Innovation Processes) process which includes four main phases: 1) Define & Discovery, 2) Design & Architecture, 3) Development & Execution, and 4) Roll Out. It also lists the roles involved in a project including founders, partners, team members, and users/stakeholders.
Enterprise Cloud Development and Agile Transformation Strategy - China 2012 Laszlo Szalvay
This is a seminar I gave throughout China the week of Oct 29th 2012. It covers the topics of Agile Software Development (Scrum, Lean, XP) and the new framework of Enterprise Cloud Development that CollabNet has been socializing. Please contact me for similar private talks at your company.
Stott & May is a boutique international search consultancy founded in 2009 and based in London specializing in finance, technology, IT, and infrastructure recruitment. The company has 50+ staff across offices in London and New York. It delivers permanent, contract, and interim recruitment services on a contingency, search, or retained basis. The senior management team includes Managing Director Stephen Stott, Chairman Laurence Rosen, and Giles Daniels who leads the permanent delivery practice and overall strategic development.
Using Six Sigma to Drive Tangible Service Desk Improvement and SavingsITSM Academy, Inc.
Kirk Holmes, itSMF USA National Capital President Emeritus, President of Holmes and Associates, will present his experience with using Sig Sigma to answer the question; How do you reduce Service Desk costs, improve quality, and fulfill the Service Desk mission?
The document summarizes a webinar hosted by the DASH7 Alliance on December 2, 2009. The webinar agenda included introductions to the DASH7 Alliance, an overview of the DASH7 technology, a case study by Evigia on their use of DASH7, and a discussion of DASH7 standardization and certification efforts. The DASH7 Alliance is a non-profit consortium advancing the use of DASH7 wireless sensor networking with over 30 global participants. Its goals include improving the DASH7 standard, certifying product compliance, educating the market, and encouraging new innovations.
Hundreds of DoD contractors and commercial organizations have adopted the Capability Maturity Model Integrated (CMMI). Their published results show improved cost and schedule performance. Despite these results, there is still community debate over the value of CMMI, and whether CMMI ratings provide sufficient guarantees of program performance. Much of the confusion results from: (1) inaccurate CMMI ratings; (2) over-estimating the benefits that CMMI provides a customer; and (3) contractors not living up to their CMMI rating. This program will explore each of these topics individually.
Does CMMI Benefit the Customer?
What are the true benefits of Level X – to the customer? This presentation will explore the issues, by examining the fundamental principles behind the model, from a customer perspective. Costs and benefits to the customer will be emphasized, focusing on the relationship of CMMI practices to productivity, predictability and speed, as well as the cost of implementing CMMI-compliant processes. Timelines for impacting program performance, and practical tips and techniques for realizing the benefits will be highlighted.
How High Maturity Projects Fail
Process maturity supposed helps project deliver predictably on-time and on-budget. Why then, have we had a string of project failures from supposedly mature organizations, even ones that have achieved high maturity (Levels 4 and 5)? The presentation will examine the reasons why projects failure, and their relationship to process maturity. Some failures are due to non-process effects -- people, products, and technology. Mature processes diminish some of these effects and amplifying others. Some of the failures are due to projects not using the assets and capabilities of a mature organization. This presentation will identify the needed assets and discuss critical project start-up activities.
How to Get Contractors to Live Up to Their CMMI Ratings
Like many sports stars and teams, it is possible to have tremendous capabilities, but not live up to those in practice. Similarly, project teams may fail to live up to the capabilities implied by their CMMI level. This presentation describes simple, but effective ways to ensure CMMI practices are used on a project, and provide measurable benefits to the customer. Methods presented are based on techniques used successful by Northrop Grumman Corporation to monitor and manage their key suppliers.
The document provides an overview of TUSC, an IT consulting company that was purchased by Rolta. It discusses TUSC's core service areas including Oracle applications and BI implementation. It also provides an overview of Piocon, an Oracle BI expert firm that was purchased by TUSC. The document then details several case studies of TUSC/Piocon's work with clients such as IPSCO, AM Castle, Chevron, and VCA Antech to implement Oracle BI solutions.
The document discusses Oracle's enterprise architecture tools and reference architecture. It outlines key enterprise architecture activities including architecture reviews and recommendations using TOGAF. It presents Oracle's enterprise reference architecture diagram depicting core systems, integration systems, and access channels supported by enterprise infrastructure and information management. The activities aim to create an enterprise IT platform through initiatives for master data management, flexibility, business insights, operational excellence, and agile/secure infrastructure.
IT Strategic Alliances is an IT consulting and staffing firm with global presence and over 30 years of experience. They offer specialized services tailored to clients' unique needs and goals. Their strategy is to provide tailored solutions through full project teams, responsibility for deliverables, or complete accountability. They have capabilities in areas like ERP implementation, testing, legacy systems, BI, and application maintenance through locations in North America and Europe. Partnering with them can help reduce costs, control spending, and increase shareholder value through proven methodologies and risk mitigation.
The document summarizes a workshop on applying federated authentication standards like SAML to the GEOSS system. It introduces the COBWEB project and its goals of integrating crowdsourced environmental data. The workshop covered previous work using SAML, related work in GEOSS, and COBWEB's initial plans to pilot federated authentication for accessing data from multiple sources. Attendees were encouraged to participate in future COBWEB authentication activities.
090602 Isto Overview And Conformity Assessment LefkinPeter Lefkin
The document provides an overview of the IEEE-ISTO (Institute of Electrical and Electronics Engineers - Industry Standards and Technology Organization). It discusses:
1. The background and history of IEEE-ISTO since 1999, including its affiliation with IEEE and role as a forum for consortia.
2. The synergies between IEEE-ISTO and IEEE-SA (Standards Association), allowing each organization to benefit and meet customer needs through complementary standards processes.
3. IEEE-ISTO's vision, mission, board of directors, current programs, and areas of expertise like program management, conformity assessment, and interoperability testing.
The document discusses challenges in the electronics industry due to economic recession, including companies reducing resources for standardization and laying off standards experts. This delays standards development and can increase costs across the supply chain. It also introduces NeoKinetics Inc. (NKI) which offers expert representation for standards development at various levels of engagement in order to help companies focus resources on core activities and lead in standardizing their intellectual property.
The document provides an overview of Fusion Applications, including:
1) Fusion Applications is a new generation of business applications built using Fusion Middleware that combines and optimizes existing Oracle applications like EBS along with improved usability and business processes.
2) It features a process-centric and intuitive user interface aligned with real-life business processes, embedded analytical dashboards, and integrated collaboration features.
3) Fusion Applications are built on a service-oriented architecture using ADF, SDO, BPEL, and other Fusion Middleware components to provide a flexible and customizable platform.
High-Quality IPTV Monthly Subscription for $15advik4387
Experience high-quality entertainment with our IPTV monthly subscription for just $15. Access a vast array of live TV channels, movies, and on-demand shows with crystal-clear streaming. Our reliable service ensures smooth, uninterrupted viewing at an unbeatable price. Perfect for those seeking premium content without breaking the bank. Start streaming today!
https://rb.gy/f409dk
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During the budget session of 2024-25, the finance minister, Nirmala Sitharaman, introduced the “solar Rooftop scheme,” also known as “PM Surya Ghar Muft Bijli Yojana.” It is a subsidy offered to those who wish to put up solar panels in their homes using domestic power systems. Additionally, adopting photovoltaic technology at home allows you to lower your monthly electricity expenses. Today in this blog we will talk all about what is the PM Surya Ghar Muft Bijli Yojana. How does it work? Who is eligible for this yojana and all the other things related to this scheme?
The Steadfast and Reliable Bull: Taurus Zodiac Signmy Pandit
Explore the steadfast and reliable nature of the Taurus Zodiac Sign. Discover the personality traits, key dates, and horoscope insights that define the determined and practical Taurus, and learn how their grounded nature makes them the anchor of the zodiac.
Best Competitive Marble Pricing in Dubai - ☎ 9928909666Stone Art Hub
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NIMA2024 | De toegevoegde waarde van DEI en ESG in campagnes | Nathalie Lam |...BBPMedia1
Nathalie zal delen hoe DEI en ESG een fundamentele rol kunnen spelen in je merkstrategie en je de juiste aansluiting kan creëren met je doelgroep. Door middel van voorbeelden en simpele handvatten toont ze hoe dit in jouw organisatie toegepast kan worden.
Unlocking WhatsApp Marketing with HubSpot: Integrating Messaging into Your Ma...Niswey
50 million companies worldwide leverage WhatsApp as a key marketing channel. You may have considered adding it to your marketing mix, or probably already driving impressive conversions with WhatsApp.
But wait. What happens when you fully integrate your WhatsApp campaigns with HubSpot?
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We take a look at everything that you need to know in order to deploy effective WhatsApp marketing strategies, and integrate it with your buyer journey in HubSpot. From technical requirements to innovative campaign strategies, to advanced campaign reporting - we discuss all that and more, to leverage WhatsApp for maximum impact. Check out more details about the event here https://events.hubspot.com/events/details/hubspot-new-delhi-presents-unlocking-whatsapp-marketing-with-hubspot-integrating-messaging-into-your-marketing-strategy/
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2. Agenda
CDISC
Background
Method & Analysis
User Requirements
Scenarios
Benefits
Next Steps
Summary
EMEA. June 7th, 2006 2
3. The CDISC Mission
Clinical Data Interchange Standards
Consortium
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.
EMEA. June 7th, 2006 3
4. CDISC Organisation
CDISC Coordinating Committee CDISC Board Committees
Leaders, Japan & Europe
Board of Directors • Executive
• Financial Oversight
• Governance
Industry Advisory Board • Global Strategy
• Global Communications
President
Global Operations
Board and IAB Support International Operations Support
Member Services New Opportunity Exploration
PR/Communications Program Management
Business Case Alliance Management
Website/IT; Interchanges Member Services
Technical Advisory Committee
Production Standards Implementation Services Innovation Initiatives
• Production Standards Updates • Education Courses • BRIDG Modeling
(SDTM, SEND, define.xml, ODM, • Global User Network Support • SDTM-ADaM Pilot
LAB, ADaM, Glossary) • Regional CDISC Coordinating Comm. • Submission in ODM XML
• End-to-end Documentation (Japan, Europe) • eSource Data Interchange
• Implementation Guide/Std • U.S. Networks • Terminology and NIH Grants
Enhancement (e.g. TDM, PK, • Implementation Enablers ( proto- • Protocol Representation
device, vaccine) tools ) • Healthcare Link
• Help Desk • Industry Architecture Proposal
EMEA. June 7th, 2006 4
5. History
CDISC Volunteer CDISC CDISC SDTM into
Group Europe Japan guidance
DIA SIAC CDISC Define.XML
Formed Incorporated guidance
1997 1998 1999 2000 2001 2002 2003 2004 2005
ODM V1.1 LAB V1.0 ODM V1.2
ODM V1.0 SDS V2.0 SDS V3.0 SDTM V1.0
(*) (*) (*)
* Note: SDS became SDTM
EMEA. June 7th, 2006 5
8. Operational Data Model
CRO Sponsor
ODM
Archive
ODM
SDTM
ODM ADaM
Investigator ODM
Define.XML
• Exchange & Archive of
clinical data
Archive
Subject
• Production Version 1.2.1
LABs
• Protocol
XML Schema
EMEA. June 7th, 2006 8
9. Laboratory Data Model
CRO Sponsor
ODM
Archive
ODM
• Exchange of LAB
data SDTM
ODM ADaM
• Production ODM
Investigator
Version 1.0.1 Define.XML
• Implementations
through SAS,
Archive
ASCII, XML/ODM
Subject LABs
and HL7 V3 RIM Protocol
message
EMEA. June 7th, 2006 9
10. Study Data Tabulation Model
CRO Sponsor
ODM
Archive
ODM
SDTM
• Submission data (Case Report
ODM ADaM
Tabulations; analysis data)
Investigator ODM
Define.XML
• Production Version 1.1
• Referenced as a specification in
Archive
FDA Guidance - 21 July 2004
Subject LABs
Protocol
EMEA. June 7th, 2006 10
11. Standards for the Exchange of Non-clinical
Data (SEND)
CRO Sponsor
ODM
Archive
ODM
• Non-clinical (animal) data SDTM
ODM ADaM
• Based upon CDISC SDS V3.1
Investigator ODM
• Included in SDTM model now Define.XML
referenced in FDA Guidance
Archive
Subject LABs
Protocol
EMEA. June 7th, 2006 11
12. Analysis Dataset Models
CRO Sponsor
ODM
Archive
ODM
• General Considerations
Document and Examples of
ODM
SDTM
ADaM
Standard Analysis Datasets ODM
Investigator
for Submissions Define.XML
Archive
Subject LABs
Protocol
EMEA. June 7th, 2006 12
13. Protocol Representation
CRO Sponsor
ODM
Archive
ODM
SDTM
ODM ADaM
• HL7-CDISC-NCI Collaboration
Investigator ODM
• Objective to develop a standard,
Define.XML
structured, machine-readable clinical
Archive
protocol representation
Subject LABs
Protocol
EMEA. June 7th, 2006 13
14. Terminology
CRO Sponsor
ODM
Archive
ODM
SDTM
ODM ADaM
Investigator ODM
Define.XML
• Covers the work of all teams
Archive
Subject LABs
Protocol
EMEA. June 7th, 2006 14
15. CDISC Projects - A Sample
• End-to-End Production Use
– How are the models used end-to-end in detail
• Device Domain
– SDTM Domain
• SDTM-ADaM Pilot
– In conjunction with the FDA
• Submission in ODM XML
– Removal of SAS Transport Files
• The Link with Healthcare
– Integrating the Healthcare Enterprise (IHE)
Profile
EMEA. June 7th, 2006 15
16. Background
• FDA Presentation, August 2004 - Reviewers
– Operational Data Model (ODM)
– The Archive Use Case
– Define.xml
• FDA Presentation, November 2004 - DSI
– ODM
– Regulations
• Suggested changes to CSUCT guidance
document
EMEA. June 7th, 2006 16
17. eSDI Group
• The electronic Source Data
Interchange (eSDI) initiative
• Started in November 2004 with the
encouragement from the Food and
Drug Administration (FDA)
EMEA. June 7th, 2006 17
18. eSDI Mission
Produce a document that would benefit
industry and FDA by providing
recommendations for the use of the
CDISC standards with associated
processes that can promote the
enhanced use of eSDI within the context
of the existing regulations for regulated
clinical research.
EMEA. June 7th, 2006 18
19. Issues
• How to transition from the paper world to the
e-World in terms of audits, reviews,
compliance to regulations
• No regulatory basis for Trusted Third Parties
• Concern about Interim Analysis
• Collection of data without adequate
psychometric validation
• Inadequate validation and control of systems
used for data collection
EMEA. June 7th, 2006 19
20. History
• Expert Focus Groups Invited for Comment
– 23rd February, Philadelphia
– 7th March, Lisbon
• 1st Draft 14th March 2005
– 4th & 5th April, DIA ePRO Conference, Arlington
– 11th April, SAS Users Forum
• 2nd Draft 25th May 2005
• 3rd Draft 11th August 2005
• 4th Draft 29th August 2005
• 5th Draft 16th September 2005
• 500+ individual comments
• 6th Draft Q2 2006
EMEA. June 7th, 2006 20
21. Content
• Psychometric validation not in document
– Now being looked at by a DIA group
• Interim Analysis
– Small reminder of current regulations and
guidance
• eSource
– Main focus of document
– How standards can help
EMEA. June 7th, 2006 21
22. Motivation and Aims
• Motivation
– Desire to solve the issue and increase adoption
• Aims
– Something tangible to shoot at, detailed enough
to allow debate and be practical
– Simple check list, well understood (a what not
how)
– Allows all stakeholders (FDA, Sponsors, Vendors
& Investigators) to assess current and future
technologies
EMEA. June 7th, 2006 22
23. Method
• Examine the paper process; if well executed,
it meets the regulatory requirements
• What are the requirements that source
documents must meet?
• What do the FDA, Sponsors and
Investigators need (key requirements) from
source documents?
• Consider
– Regulations
– Data Quality & Integrity
– Subject Safety
EMEA. June 7th, 2006 23
24. Outcome
• Checklist
– A checklist that allows industry to assess any
technology and process now or in the future
• Scenarios
– Suggested ways to move forward
EMEA. June 7th, 2006 24
25. Criticism of Approach
• Criticisms
– We don’t want to preserve paper
– Why look at the paper process
• Fundamental Question
– Why do we have source documents and data?
EMEA. June 7th, 2006 25
26. Fundamental Questions
• How do we ensure that the data submitted
are the data captured?
• How do we ensure the data captured is
accurate?
• How do we ensure the subject's safety?
EMEA. June 7th, 2006 26
27. User Requirements
• 12 in total
• As they stand today
• Open for review, discussion and debate
• The detail is in the white paper
• All are mapped to regulations
EMEA. June 7th, 2006 27
28. Requirement 1 (Old Text)
An instrument used to capture source
data shall be an accurate representation
of the protocol ensuring that the data as
specified within the protocol is captured
correctly.
EMEA. June 7th, 2006 28
29. Requirement 1 (New Text)
An instrument used to capture source
data shall ensure that the data is
captured as specified within the protocol
EMEA. June 7th, 2006 29
30. Requirement 2
Source data shall be Accurate, Legible,
Contemporaneous, Original, Attributable,
Complete and Consistent (the ALCOA
and Data Integrity requirement).
EMEA. June 7th, 2006 30
31. Requirement 3
An audit trail shall be maintained as part
of the source documents for the original
creation and subsequent modification of
all source data.
EMEA. June 7th, 2006 31
32. Requirement 4
The storage of source documents shall
provide for their ready retrieval.
EMEA. June 7th, 2006 32
33. Requirement 5
The investigator shall store the original
source document or a certified copy.
EMEA. June 7th, 2006 33
34. Requirement 6
The mechanism used to maintain source
documents shall ensure that source data
cannot be modified without the
knowledge or approval of the investigator.
EMEA. June 7th, 2006 34
35. Requirement 7
Source documents and data shall be
protected from destruction.
EMEA. June 7th, 2006 35
36. Requirement 8
The source document shall allow for
accurate copies to be made.
EMEA. June 7th, 2006 36
37. Requirement 9
Source documents shall be protected
against unauthorised access.
EMEA. June 7th, 2006 37
38. Requirement 10
The sponsor must never have exclusive
control of a source document.
EMEA. June 7th, 2006 38
39. Requirement 10
The sponsor must never have exclusive
control of a source document.
“Comments were also made
indicating that this was not a new
requirement, but intrinsic to
complying with FDA regulations
regarding clinical trials.”
EMEA. June 7th, 2006 39
40. PRO Guidance Document
• FDA Guidance for Industry.
– Patient-Reported Outcome Measures: Use in
Medical Product Development to Support
Labeling Claims
• Lines 848 & 849
– Sponsors should also plan to avoid the following:
• Direct PRO data transmission from the PRO data
collection device to the sponsor (i.e., the sponsor
should not have exclusive control of the source
document)
EMEA. June 7th, 2006 40
41. Requirement 11
The location of source documents and
the associated source data at all points
within the capture process shall be clearly
identified.
EMEA. June 7th, 2006 41
42. Requirement 12 (Old Text)
When source data are copied, the
process used shall ensure that the copy
is an exact copy having all of the same
attributes and information as the original.
EMEA. June 7th, 2006 42
43. Requirement 12 (New Text)
When source data are copied, the
process used shall ensure that the copy
is an exact copy preserving all of the data
and metadata of the original
EMEA. June 7th, 2006 43
44. Recommendations (1)
• Source at Site
– Electronic equivalent of paper
– Must be easy (practical) for the investigator
– The CDISC Operational Data Model (ODM) can
assist greatly
Source
Data
Investigator ODM
Sphere of investigator Sponsor
control
EMEA. June 7th, 2006 44
45. Recommendations (2)
• eSource System Provider
– Works on behalf of the investigator
– Must document how the 12 core requirements
are met
– This document must be open to inspection by
the FDA
Investigator
eSource System
Provider
Sponsor
EMEA. June 7th, 2006 45
46. Recommendations (3)
• Single Source Concept Sponsor
Sponsor
Database
– Single entry of data
using an EHR
– Data used, as required,
in both healthcare and
clinical research ODM
– Use of “ODM Store”
helps facilitate
compliance with the
Source
regulations EHR
Data
ODM
EMEA. June 7th, 2006 46
47. Recommendations (4)
• EHR Extraction and Sponsor
Sponsor
Investigator Verification Database
– Data extracted from the
EHR database
– Investigator verifies the
data
– Protects against 21 CFR
11 “creep”
EHR EHR
Database
EMEA. June 7th, 2006 47
48. Recommendations (5)
• Direct Extraction Sponsor
Sponsor
– Data extracted from the Database
EHR database
– EHR must be 21 CFR
Part 11 Compliant
EHR
Database
EHR
EMEA. June 7th, 2006 48
49. Next Steps - The Ideal Picture?
eSource System Provider
Investigator Sponsor
Source
Doc
EMEA. June 7th, 2006 49
50. Next Steps - The Ideal Picture?
eSource System Provider
• Read
• Create
• Read
• Update
Investigator Sponsor
Source
Doc
• Read
• Update With
Approval
EMEA. June 7th, 2006 50
51. Fundamental Questions
• How do we ensure that the data submitted
are the data captured?
• How do we ensure the data captured is
accurate?
• How do we ensure the subject's safety?
EMEA. June 7th, 2006 51
52. Output From Work
• 12 User Requirements
• 5 Scenarios
• Recommendations
• Checklist for Investigators
• Sponsor Audit Report Template
EMEA. June 7th, 2006 52
53. Summary
• The work of the eSDI group provides a clear
way forward in the use of eSource
• Core requirements and recommendations
provide the foundation stone for the building
of true e-Clinical systems
• Draft 6 being worked on, will be released via
the CDISC website, www.cdisc.org
EMEA. June 7th, 2006 53
54. Information and Contacts
• eSDI Group Leaders
– Rebecca Kush
rkush@cdisc.org
– Dave Iberson-Hurst
dave.iberson-hurst@assero.co.uk
EMEA. June 7th, 2006 54
55. Contributors
• Ethan Basch • Michael Noonan
Memorial Sloan-Kettering Cancer Asthma Research
Center
• Lisa Olson
• Peter Black SEC Associates
Scirex
• Shaghig Palanjian
• David Detoro Perceptive Informatics
Schering Plough
• Jay Pearson
• Hugh Donovan Merck & Co.
Siemens
• David Reasner
• Greg Fromell Sepracor
University of Pennsylvania
• Dana Stone
• Ed Helton Merck & Co.
SAS
• Mark Weiner
• John Jordon University of Pennsylvania
Schering Plough
• Wallace Wormley
• Suzanne Markel-Fox University of Pennsylvania
GSK
EMEA. June 7th, 2006 55
56. FDA Liaisons
• Laurie Burke
Director Study Endpoints and Label Development, Office of New Drugs
CDER
• Joanne Rhoads
Director, Division of Scientific Investigations, CDER
• Joe Salewski
Deputy Director, Division of Scientific Investigations, CDER
• Jane Scott
Study Endpoints and Label Development, Office of New Drugs, CDER
• Steve Wilson
Deputy Director, Division of Biometrics II, CDER
EMEA. June 7th, 2006 56