Enabling clinical health research and projects in the real world: collaboration, communication and collection

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1 Enabling clinical health research and projects in the real world: collaboration, communication and collection Trina Johnson, Ph.D. Covenant Health Research Day February 7, 2017

2 Presenter Disclosure Affiliation: Trina Johnson, Ph.D., ACRC Manager, Alberta Innovates Relationships with commercial interests: Grants/Research Support: None Speakers Bureau/Honoraria: None Consulting Fees: None Other: Employee of Alberta Innovates, Provincial Licensor of EDGE Clinical Research Management in Alberta

3 Presentation overview Build awareness of the ACRC, a provincial collaboration to support clinical health research Learn about two tools (EDGE & The Alberta Clinical Research Roadmap) to assist in collaboration, management, and continuous improvement of research studies and projects Discuss how the use of these tools can assist knowledge translation and the collective knowledge of living lab work in Covenant Health and the province

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5 Our vision is of high quality, integrated, efficient clinical research in Alberta. Alberta Clinical Research Consortium (ACRC): a collaborative effort BUILDING CAPACITY in Clinical Research Identify Barriers Facilitate discussions Gather Best Practice People & Training Tools & Templates Build Teams Implement Solutions Processes & Technology Integrating Health & Research

6 GUIDING the clinical research community Building relationships + gathering expertise + building tools Administration Privacy Legal Study Recruitment Metrics Training ACRC PLATFORMS: Enabling Quality, Efficient Clinical Research

7 From the experts PRIVACY PLATFORMS PROCESSES INDICATORS GUIDANCE & PROPOSED SOLUTIONS LEGAL TOOLS & TRAINING PARTICIPA- TION

8 Living Lab A Living Lab is a system enabling people, users/buyers of services and products, to take active roles as contributors and co-creators in the research, development and innovation process. A Living Lab has one main role, and this is to engage and empower users to participate in the generation of valuable and sustainable assets towards objectives set-up by its partners and customers.

9 ENoLL : Living Labs: Enabling Actions Pan-provincial collaboration platform Representational governance and advisory Mobile/virtual project management infrastructure Flexible scheduling/staffing/ enrollment Multi-site aggregation and reporting Multi- Stakeholder Participation Real-life Setting Multimethod Approach Co-creation Education and training Active User Involvement Collaboration framework / community platform Provincial portfolio of projects List of areas for development Secure location for sharing Clinical research training program Navigation support Participation / engagement platform

10 THINKING PROVINCIALLY: OUR SCOPE Reduce Administrative Approval Time & Workload Provide Clarity & Guidance Through Clinical Research Processes Implement Better Systems for Study Management Foster Professional Development and Training Opportunities 10

11 Delivering Training & Networking Opportunities Clinical Research Conference 2014 & 2015 Leadership in POR: Pragmatic Clinical Trials Certificate Clinical Research Source 12 Issues 11

12 INTERACTIVE CLINICAL RESEARCH NAVIGATOR ALBERTA CLINICAL RESEARCH ROADMAP

13 Providing Clarity & Guidance Research Roadmap One-Stop-Shop Online Interactive Process Ordered 13

14 Creating Researcher Tools 14

15 Developing Recruitment Tools 15

16 Establishing Provincial Indicators Defining Metrics Monitoring & Reporting Performance Drive Measurable Improvements 16

17 SEAMLESS EXCHANGE OF INFORMATION FOR RESEARCH TEAMS EDGE CLINICAL RESEARCH MANAGEMENT SYSTEM

18 Streamlining Processes Ethics Approval Letter + Study Documents: Protocol, Data Elements, ICF Seek Data Source Data Repository Approval s54 Research Agreement 18

19 Implementing Study Management Tools Secure, Cloud-Based Study Management System Study & Participant Management Staff & Site Coordination Study Activity Tracking for Finances In-Depth Reporting 19

20 One Province: One Project Participants Administrators Covenant Health Grey Nuns, Edmonton St. Mary s, Camrose Managers Clinical Staff Provincial Portfolio of Clinical Health Research St. Joseph s Vegreville Tom Baker Cancer Centre, Calgary Alberta Health Services Stollery Children s Hospital, Edmonton Red Deer Reg. Hospital, Red Deer

21 Easier Reporting: Together Health Region or Network Expertise Disease Participant Type Demographics Strategic Priority Organization Site Network/Team Researcher/PI Participants Staff Translating knowledge into practice Providing resources to enable evidence gathering

22 I AVOIDING SILOS: LIVING LABS ACROSS THE PROVINCE

23 The Living Lab Roadmap User Involvement Informed Consent Privacy Identifying participants Service Creation Common Language Portfolio Management Efficient Communication Technical/Service Roadmap Infrastructure IT architecture Identification and utilization of resources (money, space, time) Mulder et al. The Living Labs Harmonization Cube: Communicating Living Labs Essentials. ejov. Vol 10 (2008)

24 The Living Lab Roadmap Governance Climate of cooperation Scalability / Scope Privacy Agreements Methods & Tools Sharing Best Practice Collaboration platforms Interoperability Innovation Outcomes Shared objectives Territorial Relevance Responsive to new needs

25 Collaboration without Barriers