quality management systems in an nhs investigator site

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