Development of the Keele CTU Quality Management System

Ruth Beardmore

CTU QA Manager

Outline

• Evolution of the QMS – Wide portfolio of research

– Adaption for running CTIMPs

• Integration– University sponsorship

– CTU procedures for delivery

– Clinical Research Network (CRN)

Authors

Ruth Beardmore: CTU QA Manager

Jackie Gray: CTU Governance & QA Officer

Rhian Hughes: CTU Co-Director

Emma Skinner: Sponsor QA Manager

Jenny Stevens: Clinical Research Manager – Primary Care, CRN

Background

• SOPs developed for non CTIMPs

• Variety of research methodology

• Gap analysis

• Launch of Keele CTU QMS

• Intranet based

SOPCompliance

SOP Training&

Quality Assurance

Site Initiation and Study

Implementation

Project Development

to Approvals

Initial Concept to

Funding and Contracts

Analysis and Dissemination

Archiving

Site Initiation

and Study

Implementation

Project

Development

to Approvals

Initial Concept

to Funding

and Contracts

Analysis and

Dissemination Archiving

Project

Management

SOP 4

Site Initiation

SOP 5

Analysis and

Dissemination

SOP 16

Archiving

and Storage

SOP 17

SOP

Compliance

Development and

Management of

SOP Training

SOP 18

Writing and

Revising SOPs

SOP 1

Document Control

SOP 2

Deviations &

Breaches

SOP 21

Developing &

Submitting Grant

Proposals and

Contract Sign-off

SOP 3Study Master File

SOP 6

Document Design

and Development

SOP 7

Database Design

and Development

SOP 9

SLAs and Study

Costings

SOP 10

Regulatory

Submission

SOP 11

Research

Passports

SOP 12

The Set-up of Study

Administrative

Procedures

SOP 13

Recruitment and

Intervention

SOP 8

Monitoring, Audit

and Inspection

SOP 14

IMP Management

SOP 19

Safety reporting &

Pharmacovigilance

SOP 20

Study Closure

SOP 15

Clinical Trials of IMP

• Pharmacovigilance

• IMP management

• Clinical Trial Authorisation

• MHRA reporting

Joint Sponsor-CTU QA Office

CTU Director Head of Academic

Legal Services

CTU QA Manager Sponsor QA Manager

CTU Governance and

QA OfficerIntegrated QA Office

Keele Policies &

Procedures

CTIMP-specific frameworks / policies

Procedures for agreeing sponsorship, delegation of functions & sponsor

oversight

CTU operational SOPs

Trial-specific documentation

Integrated QMS

Streamlined Functions

• QA review of projects

• Contracting and Agreements with sites

• Pharmacovigilance

• Non-compliance

• Regulatory Inspections

Links with CRN

• Aligned processes

– Site identification

– Site set-up and initiation

– Participant identification

• Streamlined recruitment pathways

• Collaborative working

QMS Development Plans

• Comprehensive QMS review

• MHRA inspection and CAPA

• Aim to strengthen systems, including:

– Competency framework for all roles

– Training programme

– Monitoring and audit

Keele CTUDirectorate of

Engagement and Partnerships

Keele University, Keele, Staffordshire ST5 5BG

www.keele.ac.uk