clinical trials ontario streamlined research ethics review system susan marlin president and ceo...
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Clinical Trials Ontario
Streamlined Research Ethics Review System
Susan Marlin
President and CEO
CAREB NATIONAL MEETING 2015
ABOUT CLINICAL TRIALS ONTARIO
Clinical Trials Ontario is an independent not-for-profit organization
Established by the Province of Ontario in response to:
Significant decline in clinical research in Ontario Recognition of:
research strengths (e.g. excellent research capacity, high quality data) areas to improve (e.g. speed, cost)
Mandate for CTO
Support a streamlined approach to conducting multi-centre clinical trials in Ontario while ensuring the highest ethical standards for patient safety
First priority – implementing a streamlined research ethics review system
CTO STREAM LAUNCHED: MARCH 4, 2015
New streamlined system for research ethics review launched in Ontario
Press release posted on ctontario.ca
386 page views from Canada, UK, Japan, United States, Germany, India, Australia and Hong Kong.
Stakeholder Pick-up
Life Sciences Ontario
Ontario SPOR SUPPORT Unit
CAHO Catalyst
CAREB
MEDEC
The System
CTO STREAMLINED RESEARCH ETHICS REVIEW SYSTEM
Supports a single REB in providing research ethics review and oversight to multiple research sites; relies on a “REB of Record Model”
REB oversight responsibilities delegated by participating institutions to the REB of Record
Can be used for any multi-site clinical research, i.e. industry sponsored or investigator initiated
Currently can accept multi-site clinical trials; in future multi-site health research will be accepted as well
Primary components:
CTO REB Qualification Program
CTO Stream: Web-based Research Ethics Review System
The Three P’s: Policies, Procedures & Paperwork
CTO REB QUALIFICATION PROGRAM
Provides REBs planning to participate in the CTO Streamlined Research Ethics Review System with an external review of their governance, membership, operations and review procedures.
Based on the Toronto Academic Health Sciences Network (TAHSN) qualification process.
REBs are reviewed against a transparent standard, the CTO REB Qualification Checklist, that is informed by the applicable regulations, policies and guidelines. REB Qualification Manual available at www.ctontario.ca.
CTO REB Qualification checklist aligned with the N2/CAREB REB SOPS.
Each full visit is conducted by a Qualification Team composed of: Auditor with specific training relating to review of REBs CTO Program Coordinator Two experienced members from the research ethics community (e.g., REB Chair/Vice-Chair
and REB Director/ Manager/ Coordinator) selected from the CTO College of Reviewers.
CTO REB QUALIFICATION PROGRAM
REB SOPs reviewed prior to on-site visit; on site interviews with REB Chair(s) & operations team and review of facilities and documentation.
Report issued following visit; all items (200+) must be addressed before “Qualification” status issued.
Qualification status remains in effect for 3 years with submission of annual updates.
8 REBs are CTO Qualified in Ontario; 2 in process; several others preparing;
Lessons learned: Different ways to be compliant; documentation is key Common issues/questions/concerns:
quorum, incidental findings, appeals, finding and maintaining REB members (e.g. law, community); staying on top of emerging issues and education
REB Council to be convened soon (goal: 10 REBs qualified); composed of REB Chairs and REB Operation Leads from each qualified REB.
CTO STREAM
Standalone web-based electronic platform: Enables research ethics review, document management, and communication between
multiple institutions and multiple REBs Uses common application forms standardized for all types of clinical trials Built on Infonetica platform
CTO Stream is built using the latest technology and is continuously being improved based on community feedback
Supports the latest version of the most popular browsers (Internet Explorer, Google Chrome, Firefox, Opera and Safari)
Supports all mobile platforms and tablets (Apple, Android and Blackberry) Supports any file type for uploads (i.e., word documents, excel documents, pdfs and text files)
Built using smart questions and smart forms Uses electronic signatures for all applications User friendly easy to use environment with 24 hour support provided by CTO and Infonetica
Launched March 4, 2015 at the CTO Conference; studies going through system
Using the CTO Streamlined Research Ethics Review System
INSTITUTIONAL RESPONSIBILITIES
Per TCPS2
Accountable for the research carried out in its own jurisdiction or under its auspices.
Responsible for the ethical acceptability and ethical conduct of research undertaken within its jurisdiction or under its auspices.
Establish or appoint REB(s) to review their research; can be an REB external to the institution; can establish/appoint one or more.
Grants the REB the mandate to review the ethical acceptability of research on behalf of the institution, including approving, rejecting, proposing modifications to, or terminating any proposed or ongoing research involving humans. (TCPS2 Article 6).
Delegation of research ethics review responsibilities to another REB requires a formal agreement.
The REB is responsible for research ethics oversight, and protecting the rights, safety, and well-being of research participants (GCP and CGSB)
CTO PARTICIPATION AGREEMENT
Between CTO and Participating Institutions (e.g. academic hospital, community hospital, university)
Sets out CTO’s and the Participating Institution’s respective rights and obligations
Participating Institutions can serve as:
REB Host Institution: Institution has established an REB that is qualified (or to be qualified) by CTO and will serve as an REB of Record for multi-site clinical/health research
Recruiting Site: Investigators working under the auspices of the Institution will recruit participants to studies approved through the CTO System
Both
Includes as Schedule E the REB of Record Study Agreement, executed on a study-by-study basis Parties to the agreement: REB Host Institution of the REB of Record, Institution of the Recruiting Site, and
the Principal Investigator at the Recruiting Site. Template agreement formally delegates REB review and oversight responsibilities to the REB of Record and
must be executed prior to the start of the study at each Recruiting Site .
ASSIGNING THE REB OF RECORD
Industry Sponsored/Led Studies: CTO will look first at matching the study area to REB expertise If more than one qualified REB with expertise, will assign REB based on balancing workload
of CTO studies amongst REBs
Investigator Led Studies: Preference will be to assigning to the ‘home’ REB of the lead investigator; REB likely to have
the expertise, and some desire expressed in the community for having more institutional support for Investigator led studies
If ‘home’ REB not possible, CTO will look to match REB expertise If more than one qualified REB with expertise, will assign REB based on balancing workload
of CTO studies amongst REBs
REB REVIEW FEES – INDUSTRY SPONSORED TRIALS
Industry Sponsor Charged $3000 for each of the 1st 5 participating sites; $2000 for each of the next 5 and
$1500 for each additional site after 10; $500 for the 4th and subsequent major amendments
REB of Record Institution Receives $5000 for the initial review and $250 for each participating site after 2; $500 for the
4th and subsequent major amendment
Recruiting Site Institution Receives $500 per CTO trial they participate in, if they have an internal REB or support an
institutional REB – allocated to support REB activities
JOINING THE CTO SYSTEM
Learn about the CTO System: CTO website, webinars, manuals + customized visits, presentations, webinars etc.
Understand and implement what policy, governance, procedural changes etc. need to implemented to use the system; all non-ethics local requirements for study initiation will need to be met
If your institutions intends to be a REB Host institution and is not qualified, prepare for REB Qualification (N2/CAREB SOPs)
Review and sign the CTO Participation Agreement
Customized training provided: REBs, investigators, institutional representatives
REB OF RECORD MODEL
Initial Application Process
REB application submitted by any registered investigator/site, i.e. “Provincial Applicant”
CTO assigns REB of Record (any Qualified REB in Ontario) and advances application
REB of Record reviews application and resolves any issues with applicant
Once issues are resolved REB of Record approves study
Recruiting Institution signs REB of Record Agreement, delegating ethics review and
oversight to REB of Record; Local PI adopts approved consent form and submits site
application focused on site specific information
Site application advances to REB of Record
REB of Record Host Institution signs REB of Record Agreement and REB reviews
application (usually expedited) and resolves any issues with site applicant
Step 1Applying for a New Multi-Centre
Clinical Trial
Step 2 Adding New Investigators /
Research Sites
Sites wishing to participate are notified and given access to REB materials in CTO
system
REB of Record issues approval for site to participate
Continuing Oversight and Approval
Documentation submitted by “Provincial Applicant”
REB of Record reviews submission and resolves issues with provincial applicant
Once issues are resolved, approval or acknowledgement is issued by REB of Record
and sent simultaneously to all approved participating sites
REB of Record reviews submission and resolves issues with research site
Approval or acknowledgement issued by REB of Record
New overall (study-level) event, e.g. amendment, Data Safety Monitoring
Board report, safety update
New site level event, e.g. continuing (annual) review, local Serious Adverse
Event, protocol deviation
Documentation submitted by research site
REB OF RECORD MODEL
Building the System
LEARNING FROM WHAT HAS BEEN DONE
Programs/Systems/Expert Papers etc. reviewed
Other programs for streamlining/harmonization – provincial, international E-REB systems, locally and internationally TAHSN REB System RFP TAHSN REB Qualification Manual AAHRPP accreditation process Processes/policies etc. from multiple REBs OCREB’s “Everything”, in detail CIHR External Advisory Committee on Streamlining Health Research Ethics Review (SHRER) Forms from multiple REBs Consents from multiple REBs, groups etc. CAREB guidance – e.g. SAEs N2/CAREB REB SOPs
LEARNING FROM THOSE WHO DO IT
BUILDING TOGETHER
External Committees/Groups REB Streamlining Working Group Legal and Liabilities Working Group IT and Metrics Working Group Research Ethics Review Advisory Group College of reviewers Technical/Operations Committee E-REB RFP Evaluation Committee E-Forms Working Group (Clinical Trials) Model Clinical Trials Agreement Participant Engagement Advisory Group Industry Advisory Group CTO Participation Agreement Advisory Group E-Forms Working Group (non-clinical trials)__________________________________________Total = 109 Volunteers
Community Experts Hired PT/Seconded: 9 CTO In-house Team: 7
CTO 2015 CLINICAL TRIALS CONFERENCE
“TO DO LIST”
Streamlined Research Ethics Review System Initiate the CTO REB Council Support multi-centre health research (non clinical trials) Implement CTO Registry & Reporting capabilities Develop template consent form (clinical trials) Explore opportunities for provincial collaborations Develop and offer CTO Stream for local REB review
Other Streamlining Measures Clinical Trial Agreements Determine other opportunities for streamlining/efficiencies
Participant/Public Engagement Landscape review: Determine programs/areas where CTO can add value Public / Participant surveys – partner with BCCRIN Engage with health charities & patient advocacy groups Develop participant & public facing materials for the website Engage participant & public in program development where appropriate (e.g. sample consent
forms)
CONTACT INFORMATION
Website: www.ctontario.ca
E-mail: susan.marlin @ctontario.ca
@clinicaltrialON
linkedin.com/company/clinical-trials-ontario
Clinical Trials Ontario661 University Avenue, Suite 460MaRS Centre, West TowerToronto, Ontario Canada M5G 1M1 Tel / 416.276.1381
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