Quality Assurance (QA) Team

The purpose of the QA team is

  • To assure that all clinical trials sample analysis and associated activities (such as method validation) are conducted in accordance with GCP, EU and UK Clinical Trials Regulations, Directives and Amendments
  • To promote and support a culture of quality leading to scientific excellence within the GCP team of CEP​

The Quality Assurance team are routinely involved in the following activities:

Project Activation Reviews

  • To ensure compliance with GCP, regulatory and contractual requirements and local CEP procedures

Document Reviews

  • To ensure compliance with GCP, regulatory requirements, relevant guidance and local CEP procedures

Compliance Advice

  • To promote and support a culture of compliance via guidance in the interpretation of GCP, regulatory and contractual requirements and local CEP procedures

Auditing

  • Internal auditing is conducted to confirm compliance, minimise any risks of non-compliance, identify any procedural gaps and maintain continuous improvement in a systematic way

Data Audits

  • To ensure the validity and accuracy of laboratory data prior to release to sponsor(s)

Non-Conformance Support

  • To correct the consequences of errors that have the potential to impact integrity or reliability of trial data, patient confidentiality, patient consent or patient safety and to minimise the likelihood of reoccurrence

Document Control

  • To ensure documents are reviewed, approved and distributed appropriately and that superseded and withdrawn/suspended documents are retained, but are secured to prevent unintended use

Archiving

  • To prevent unauthorised access and changes to, or loss of, retained records and materials. Access to the archive is controlled by, and restricted to, the archivist and a deputy archivist

Quality Management System (QMS) Development Projects

  • Current projects include the introduction of a new non-conformance process, a new change control process and assessing the impact of the new EU clinical trials regulation on the CEP QMS

Organisational Structure