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

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

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

Identify Barriers

Facilitate discussions

Gather Best

Practice

Build Teams

Implement Solutions

Alberta Clinical Research Consortium (ACRC): a collaborative effort

Our vision is of high quality, integrated, efficient clinical research in Alberta.

BUILDING CAPACITY in Clinical Research

People & Training

Tools & Templates

Processes &

Technology

Integrating Health & Research

Administration

Privacy

Legal

Study Recruitment

Metrics

Training

Building relationships +

gathering expertise +

building tools

GUIDING the clinical research

community

ACRC PLATFORMS: Enabling Quality, Efficient

Clinical Research

From the experts…

GUIDANCE & PROPOSED SOLUTIONS

PRIVACY

PROCESSES

LEGAL

PARTICIPA-TION

TOOLS & TRAINING

INDICATORS

PLATFORMS

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.

Living Labs: Enabling Actions

• ENoLL : http://www.openlivinglabs.eu/node/1429

• Clinical research training program

• Navigation support • Participation /

engagement platform

• Collaboration framework / community platform

• Provincial portfolio of projects

• List of areas for development

• Secure location for sharing

• Education and training

• Pan-provincial collaboration platform

• Representational governance and advisory

Co-creation

Active User Involvement

Multi-method

Approach

Real-life Setting

Multi-Stakeholder Participation

• Mobile/virtual project management infrastructure

• Flexible scheduling/staffing/enrollment

• Multi-site aggregation and reporting

Provide Clarity & Guidance Through

Clinical Research Processes

Reduce Administrative Approval Time

& Workload

Implement Better Systems for Study

Management

Foster Professional Development

and Training Opportunities

THINKING PROVINCIALLY: OUR SCOPE

10

Delivering Training & Networking Opportunities

11

Clinical Research Conference 2014 & 2015

Clinical Research Source

12 Issues

Leadership in POR: Pragmatic Clinical Trials Certificate

ALBERTA CLINICAL

RESEARCH ROADMAP

INTERACTIVE CLINICAL RESEARCH NAVIGATOR

Providing Clarity & Guidance

13

Research Roadmap • One-Stop-Shop

• Online

• Interactive

• Process Ordered

Creating Researcher Tools

14

Developing Recruitment Tools

15

Establishing Provincial Indicators

16

Defining Metrics

Monitoring & Reporting Performance

Drive Measurable Improvements

EDGE CLINICAL RESEARCH

MANAGEMENT SYSTEM

SEAMLESS EXCHANGE OF INFORMATION FOR RESEARCH

TEAMS

Ethics Approval Letter +

Study Documents: Protocol, Data Elements, ICF

Streamlining Processes

18

Seek Data Source

Data Repository Approval

s54 Research Agreement

Implementing Study Management Tools

19

Study & Participant Management

Staff & Site Coordination

Study Activity Tracking for Finances

In-Depth Reporting

Secure, Cloud-Based Study Management System

Provincial Portfolio of Clinical Health

Research

Covenant Health

Grey Nuns, Edmonton

Participants

Administrators

Managers

Clinical Staff

St. Mary’s, Camrose

St. Joseph’s Vegreville

Alberta Health Services

Tom Baker Cancer Centre, Calgary

Stollery Children’s Hospital, Edmonton

Red Deer Reg. Hospital,

Red Deer

One Province: One Project

Easier Reporting: Together

• Translating knowledge into practice

• Providing resources to enable evidence gathering

Health

• Disease

• Participant Type

• Demographics

• Strategic Priority

Region or Network

• Organization

• Site

• Network/Team

Expertise

• Researcher/PI

• Participants

• Staff

AVOIDING SILOS: LIVING

LABS ACROSS THE

PROVINCE

I

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)

The Living Lab Roadmap

Governance

Climate of co-operation

Scalability / Scope

Privacy Agreements

Methods & Tools

Sharing Best Practice

Collaboration platforms

Interoperability

Innovation Outcomes

Shared objectives

Territorial Relevance

Responsive to new needs

Collaboration without Barriers