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Quality Assurance

NWORTH Quality Management System

How can the NWORTH Quality Assurance team support your study?

The NWORTH Quality Assurance (QA) team provide specialist advice to trial teams and NWORTH staff, ensuring that every trial is conducted in compliance with Good Clinical Practice (GCP) and all relevant regulatory and ethical regulations, policies and guidelines. Our QA team can support trial teams with:

  • Conducting study risk assessments
  • Answering general QA queries throughout the trial鈥檚 lifetime
  • CRF and database verification and validation
  • Archiving of trial documentation

The QA team also provide overarching QA oversight to the NWORTH CTU. They are responsible for:

  • Development and review of standard operating procedures (SOPs)
  • Training NWORTH team members
  • Conducting internal audits to provide assurance that NWORTH systems and processes are fit for purpose & identifying opportunities for improvement
  • Identifying non-compliance with SOPs and regulations
  • Resolution of non-conformance & implementing corrective actions
  • Maintaining all quality records and documentation
  • Preparing for inspections/audits by regulatory bodies 

Underpinning documents

All NWORTH processes are underpinned and documented in Standard Operating Procedures (SOPs).  We鈥檝e also developed a suite of Work Instructions (WIs), which provide internal team members with more detailed instructions for several activities. These documents ensure that activities are carried out consistently by NWORTH staff and study teams, and are compliant with regulatory requirements. 
All of our SOPs are written in compliance with the applicable regulations, guidelines and principles governing clinical trials. This includes, but is not limited to,: 

  • UK policy framework for Health and Social Care Research
  • Medicines for Human Use (Clinical Trials) Regulations 2004 No.1031 (and all subsequent amendments) 
  • ICH Good Clinical Practice and Internal Guidelines
  • General Data Protection Regulations (GDPR)
  • NHS guidelines, policies & clinical governance