BCCRIN Quality Management Task Force Objectives

Objective

Details

Timeline

Resources

Measuring Success

  1. To establish an organizational framework by which to deploy a quality management program (linking research sites with BCCRIN)

The BCCRIN Asset Map identifies a large number of clinical trials groups. There are even greater numbers of individuals affiliated (or not) with BC research organizations who are conducting patient-oriented research.

In evolution, 2010-2012

BCCRIN executive and steering committee

Each BCCRIN-affiliated patient-oriented research group will be identifiable on the BCCRIN organization map which will show institutional and functional groupings (by which to deploy and feedback on a quality program)

  1. To ‘set the quality bar’ (opting to use the UK Clinical Research Collaboration www.ukcrc.org certification programs and best practices to evaluate units.

The BCCRIN Quality Task Force has agreed on principles and criteria adapted from the UK Clinical Research Collaboration (UKCRC.org) that define minimum criteria as:

  • A track record and experience conducting studies
  • Presence of robust quality-assurance systems and processes to meet applicable regulations and legislation
  • Evidence of stability with longer-term viability and capacity

Completed January 2011

BCCRIN Quality Task Force

BCCRIN- affiliated patient oriented research (POR) groups “measure up”

  1. To determine ‘the gap’ between expected and actual quality management systems and practices

This can be assessed by external or internal review. A Self-Evaluation will help qualify the large number of groups identified in the Asset Map, and serve as the means to communicate the intent of BCCRIN to set standards for the conduct of patient-oriented research in BC.

2011-12

  • Financial for external consultants
  • Project manager/assistant to set-up and track Self-Evaluation
  • Communication

Reviews competed for each POR affiliated organization.

  • External consultant review completed for CFRI (May 2011)
  1. Develop a BCCRIN Quality Management Program
  • Establish Quality Management Systems for :
    • Document Management
    • Deviation, CAPA, and Investigations
    • Auditing and vendor qualification
    • Training
    • Continuous Quality Improvement
    • Other Quality Assurance Standard Operating Procedures
  • Create Standard Operating Procedures reflective of practice within each organization
    • Privacy
    • IT
    • Data Management
    • Institutional procedures
    • Project and study management
    • Quality policy and procedures
    • Study Site specific procedures
    • Biometrics
  • Establish viable IT platform with validated and secure computerized systems
  • Establish viable Data Management program
  • 5. Develop Training at all levels

2011-2014

  • Financial
  • FT Project manager to develop, oversee and coordinate activities within/between BCCRIN-affiliated organizations
  • Communication and networking

Systems and procedures will be in place and there will be a broad awareness of these within research organizations, amongst research staff, and research study participants

Cross-institutional Data and Safety Monitoring Board (DSMB)will be established

  1. Establish systems and procedures for continuous monitoring, evaluation and improvement of quality measures
 

2012 –

  • Financial
  • FT Project manager to develop, oversee and coordinate activities within/between BCCRIN-affiliated organizations
  • Communication and networking

A quality network within BCCRIN will represent all POR affiliated research organizations, and provide a means for CQI.
The BCCRIN Quality Program interacts with other national and international programs.