quality management systems in an nhs investigator site
TRANSCRIPT
Bringing Quality to Life: Quality Management Systems
in an NHS Investigator Site
Piran Sucindran
Quality Manager
Oncology and Haematology Clinical Trials
Guy’s and St Thomas’ NHS Foundation Trust
London, UK
Bringing Quality to Life
Who is the OHCT?
What is the OHCT QMS?
What is the impact of a QMS at an investigator site?
How can a QMS be implemented?
How do you engage the investigator site team?
Framework for investigator site QMS
Oncology and Haematology
Clinical Trials (OHCT)
Research support team
Safety & Support team
Clinical trials infrastructure
Patient experience and scientific integrity
7 1715
The OHCT Quality
Management System
The OHCT Quality
Management System
The OHCT Quality
Management System
Quality Management in Frontline
Clinical Trials
Challenges
Change existing system
Generic SOPs
Quality Assurance
Lack of uniformity
Importance of quality systems
Resources
Senior management buy-in
Team engagement
Quality Improvement Group
Monthly group
All levels of the team
Management
Research Nurses
Trial Practitioners
Trial Coordinators
Primary aims:
SOPs & WDs
Risk Management
Innovation
The OHCT Quality
Management System
Deviation Reporting
Standard Operating
Procedures
Quality Improvement
Group
Engagement and Shared
Vision
TrainingInternal
Monitoring
Resource Management
Knowledge Management
Evaluation of the OHCT QMS
What is the impact of the implementation of a quality
management system in frontline NHS research?
How can a clinical trials team most effectively implement
and maintain a quality management system in an NHS
investigator site?
How does one engage a clinical trials team in an NHS
investigator site in the development of and compliance to
a clinical quality management system?
Impact of an Investigator Site
Quality Management SystemStandard Operating Procedures
80% used SOPs as regular source of reference
• Amendments
• Patient Expenses Reimbursement
• Archiving
60% referenced SOPs to Sponsors
• Code of Connection
• Equipment Maintenance
100% compliance with SOP sign-off
Reassurance for Sponsors
Continual improvement
Impact of an Investigator Site
Quality Management SystemInternal Monitoring Systems
82% felt comfortable reporting deviations
• Blame-free culture
• Support, Improvement and Safety
Reassurance that issues are detected and CAPA in place
Impact of an Investigator Site
Quality Management SystemInternal Monitoring Systems
82% felt comfortable reporting deviations
• Blame-free culture
• Support, Improvement and Safety
Reassurance that issues are detected and CAPA in place
Performance metrics
50%
55%
60%
65%
70%
75%
80%
85%
90%
95%
Qtr 1 13-14 Qtr 2 13-14 Qtr 3 13-14 Qtr 4 13-14 Qtr 1 14-15 Qtr 2 14-15 Qtr 3 14-15 Qtr 4 14-15 Qtr 1 15-16
% C
om
plia
nce o
f S
ourc
e D
ocum
enta
tion
Visit Date
Implementation and
Maintenance of a QMSComprehensive QMS
Mirroring Sponsor/CRO QMS
Sponsor engagement
Deviation reporting
Identifying issues
CAPA management
Clinical limitations
Protocol requirements
Continual improvement
Limited by ‘over-processing’
Engagement of SiteTeam
94% team engaged
Regular quality input in meetings
Senior management
Clinical team
Non-clinical team
Quality Improvement Group
External engagement
Conferences
Protocol consultation
Sponsor collaboration
Engagement
QMS Framework
QIGProcessesInternal
Monitoring
Resource Management
Training and Competencies
Knowledge Management
Risk Management
Acknowledgements
@GSTTohct
Thank you
Piran Sucindran
Quality Manager
Oncology and Haematology Clinical Trials
Guy’s and St Thomas’ NHS Foundation Trust
London, UK