Quality assurance and regulatory affairs

Our quality management system includes:

• personnel roles and responsibilities
• training, policies and procedures
• risk management
• quality assurance and auditing
• document management
• record retention and reporting
• Corrective And Preventive Actions (CAPA)
• a procedure for investigating suspected fraud and misconduct.

We use Q-Pulse to effectively manage the Centre-wide quality management system. Q-Pulse is an electronic quality management system that helps organisations manage quality, safety and risk effectively. It provides employees with a central focal point for all compliance data, materials and activities. In addition, Q-Pulse makes management aware of areas in need of attention to ensure ongoing and current compliance status.

Q-Pulse provides a suite of integrated modules to manage business functions effectively and efficiently including:

• document control
• issues and CAPAs
• audits and findings
• mandatory reporting system
• staff competency and development
• other specialised modules, including asset, customer and supplier management.

We have a qualified and responsible management team to provide governance for the whole study process.

We are committed to staff education, learning and development. Our aspiration is to help each other to be the best and to do our best, recognising the different needs and aspirations of every individual. We help and support staff to manage their own learning so that they maximise their potential, develop their skills, improve their performance and contribute to the knowledge and performance of their teams.

Our audit programme is determined by applying the principles of quality risk management.

Our Internal Audit Group meets at least biennially to monitor and review the audit function in terms of independence, objectivity and effectiveness of internal audit. The Audit Group recommends the audit programme based on the level of risk.

Independence

Audit is performed by individuals independent of those conducting the activity i.e. not involved in the day to day activities and/or separate line management. Our auditor performs audits which are designed to determine whether the quality control (QC) activities have been implemented effectively, and to assure management of compliance with the principles of good practice. Audit involves review of a sample of data to test the system.

We have an internal Quality Management Group, Risk Assessment Group, Standard Operating Procedure (SOP) Steering Group and Learning and Development Group, to steer the delivery of high quality processes, risk management, training and documentation at the Centre.

Our quality management system consists of process documents including policies, SOPs, templates, forms and controlled documents which are all managed through the document module of Q-Pulse. This replaces the previous SOPs for our clinical trials units. The clinical trials unit (CTU) SOPs and experience from previous Medicines and Healthcare products Regulatory Agency (MHRA) inspections have been used to develop Centre SOPs. The processes have been streamlined and improved upon.

Process and review

Process documents are available for all areas of work including funding, contracts, trial management, data management, document management, statistics, pharmacovigilance, quality assurance, training, business continuity and qualitative. The process documents cover all the UK Clinical Research Collaboration (UKCRC) essential areas.

Review dates are set in Q-Pulse for all process documents. The document owner is responsible for reviewing and revising process documents as required. Any member of staff can raise a change request against any process document. Ad hoc changes to process documents may be made outside of the review period if necessary.

Standard Operating Procedure Steering Group

The Standard Operating Procedure (SOP) Steering Group reviews acknowledgements, change requests and status of SOP reviews periodically. Draft SOPs are reviewed and approved by relevant staff prior to authorization by a Director. All draft SOPs are reviewed for regulatory compliance by a member of the QA team prior to authorization by the Director. Once authorized by the director an impact assessment form is completed which documents the training required, review period and impact of new process document on current trials. Quality checks are performed prior to and during the activation of the process document.

SOP distribution

Once the SOP is activated it is distributed to relevant staff in Q-Pulse. Staff are required to read and acknowledge SOPs in Q-Pulse, and also receive all appropriate training prior to the SOP active date.

Ongoing refresher SOP training is provided where required. A SOP training matrix documents which staff require what level of training for each SOP and policy.

A SOP route map is also available to guide staff to which SOPs are applicable to each stage of the trial and study, from initial adoption by the Centre for Trials Research, through to funding, sponsorship, trial set up and initiation, development of trial documentation (including protocol and case report form (CRF)), database development, data collection and management, and reporting.

Our centralised quality assurance (QA) and regulatory affairs (RA) team is responsible for delivering quality assurance, audit, and regulatory affairs including pharmacovigilance and safety for the Centre for Trials Research for a wide range of trials and studies, across all our research areas.

Auditor

Responsible for independent audit of Centre trials, systems and processes.

Quality assurance managers

Responsible for providing advice and guidance, training and developing, and leading specialist areas within QA and RA. QA Managers:

• review trial documentation (including trial protocols, risk assessments, CRFs, participant information sheets) prior to finalization
• review process documents prior to finalization
• perform a quality check of clinical database documentation prior to the database becoming live.

Specialists in pharmacovigilance and safety

Responsible for providing expertise to the trial teams for receiving, administering and onward reporting of reporting serious adverse events. Their role also includes:

• the provision of specialist pharmacovigilance training and advice to trial teams (including investigators)
• the design of high quality safety reporting procedures in protocols and SOPs for phase 1 to phase 3 trials.

The quality assurance and regulatory affairs team offer services in the following areas to investigators and organisations (including NHS Trusts, universities and other clinical trials units):

• Pharmacovigilance and safety reporting
• Development of a Quality Management System (including SOP development)
• Audit
• Regulatory inspection
• Quality assurance and regulatory affairs training

The QA and RA team has 20 years plus experience of working in clinical trials quality assurance, regulatory affairs and pharmacovgilance and safety reporting.  This includes commercial and non-commercial clinical trials of investigational medicinal products phase I to III, and clinical and non-clinical studies.  We have a broad range of skills and expertise within a team that comprises of the Head of QA & RA, Quality Assurance Managers, an independent auditor, a Regulatory Affairs Manager and a team of Pharmacovigilance and Safety Specialists with administrative support.

For further information please contact: