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Quality First
A Program Any Site Can Implement
A site aligning compliance guide your site needs and
will be able to implement
Standards Committee - Our Charge
• Work with the Leadership Council and,
stakeholders to:
– Identify, Set and or, Endorse industry best site
practices.
2
Committee
Standards Committee Members
• Guido R. Visconti – Committee Chair
– Allegiance Research Specialists, LLC
• Deena Bernstein
– Discovery Clinical Research, Inc.
• Jeff Cooper, MD
– WIRB-Copernicus Group IRB
• Susan Donahue
– PMG
• Bruce K. Howson
– First Choice Insurance Intermediaries, Inc.
• Baber Khan, MD
– Longwood Research
• Liz Wool, CCRA, CMT
– QD-Quality & Training Solutions, Inc.
Special Contributors
– June Long
• Clinical Research Connections, LLC
– Brock McConnehey, DO
• Northwest Clinical Trials
3
Stakeholders
VOLUNTEERS
Sites &
Collaborators
Research
Industry
4
5
Safety
QualityCompliance
Safety Culture
• The enduring value and prioritization of worker and
public safety by each member of each group and in
every level of an organization. It refers to the extent
to which individuals and groups will commit to
personal responsibility for safety; act to preserve,
enhance and communicate safety concerns; strive
to actively learn, adapt and modify (both individual
and organizational) behavior based on lessons
learned from mistakes; and strive to be honored in
association with these values. VON THADEN, T.L. and GIBBONS, A.M. (2008) The safety culture
indicator scale measurement system (SCISMS)
6

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Site Safety Framework & Safety Culture

  • 1. Quality First A Program Any Site Can Implement A site aligning compliance guide your site needs and will be able to implement
  • 2. Standards Committee - Our Charge • Work with the Leadership Council and, stakeholders to: – Identify, Set and or, Endorse industry best site practices. 2
  • 3. Committee Standards Committee Members • Guido R. Visconti – Committee Chair – Allegiance Research Specialists, LLC • Deena Bernstein – Discovery Clinical Research, Inc. • Jeff Cooper, MD – WIRB-Copernicus Group IRB • Susan Donahue – PMG • Bruce K. Howson – First Choice Insurance Intermediaries, Inc. • Baber Khan, MD – Longwood Research • Liz Wool, CCRA, CMT – QD-Quality & Training Solutions, Inc. Special Contributors – June Long • Clinical Research Connections, LLC – Brock McConnehey, DO • Northwest Clinical Trials 3
  • 6. Safety Culture • The enduring value and prioritization of worker and public safety by each member of each group and in every level of an organization. It refers to the extent to which individuals and groups will commit to personal responsibility for safety; act to preserve, enhance and communicate safety concerns; strive to actively learn, adapt and modify (both individual and organizational) behavior based on lessons learned from mistakes; and strive to be honored in association with these values. VON THADEN, T.L. and GIBBONS, A.M. (2008) The safety culture indicator scale measurement system (SCISMS) 6