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Quality Assurance and Audit

Quality Assurance

Quality is about making an organisation perform for all of their stakeholders, from improving products, services, systems and processes, to making sure that the whole organisation is fit and effective. Quality Management is a never ending pursuit of excellence, striving to ensure all Clinical Trials, Research Studies and Systems within GG&C are not only fit for purpose, but keep improving.

 

The expected level of Quality for Research and Innovation is that which has been set by all of our Stakeholders as well as external Standards, from Sponsor Staff to Trial Teams, Suppliers to Patients, along with any and all applicable regulatory bodies. It is the responsibility of all staff to strive to meet this level and meet all of the applicable Standards which must be worked to (GCP, UK Policy Framework for Health and Social Care Research, etc). It is the responsibility of the Quality Team to assist everyone in meeting these standards.

 

The Quality System within Research and Innovation is the vehicle by which this is achieved, a set of controlled procedures are in place and under constant review for improvement and to assure compliance. The Quality Team have a number of activities and areas of influence to ensure this system is working effectively and maintained.

 

The two main areas of interest for the work of the Quality Team falls in to two main Categories, Quality Assurance(QA) and Quality Control(QC).

 

Quality Assurance is the “big picture” of Quality and looks to how Quality is baked in to our processes and activities, this is the consideration of how what we do will result in a Quality outcome. Quality Assurance is a proactive approach to achieving quality and is the consideration of what can be achieved before a task is performed, this involves an assessment of the fitness for purpose of a process. For example, QA is the review of the process defining how data is entered or transferred.

 

Quality Control is then a consideration of the fine detail, this looks at the output of an activity to ensure it meets the required standards, this level of activity is not solely the responsibility of the Quality Team but of all staff involved. Quality Control is the reactive element of Quality, it is the process of checking a completed activity to ensure it is compliant with set processes. For example, QC is the process of confirming that data entered or transferred is correct.

 

This is a symbiotic relationship and the Quality Control activity will feed in to the Quality Assurance, when an issue is identified through QC, QA will seek to prevent the issue from reoccurring.

 

The Quality Team are responsible for a number of important activities, a non-exhaustive list of some examples are:

  • Management of SOPs

Standard Operating Procedures (SOPs) form the backbone of the Quality Management System for R&I, as such their management is vital to ensure efficient, controlled and uniform conduct across all trials. It is the remit of the Quality Department to ensure all SOPs are constructed in accordance to a controlled format, routinely maintained, readily available and appropriately distributed.

This activity involves interaction with every individual who is involved with the content of SOPs, both in their design and in following the content. The quality department engages with owners of the SOPs during regular review periods, to review content and suggest improvements, to distribute to all designated stakeholders and gather evidence of training, compliance and instances of deviation from SOPs as well as identifying gaps in the existing suite of SOPs where new procedures are required. This is an ongoing cycle and feeds in to the continuous development of the department.

  • Vendor Assessments

For NHS GG&G Sponsored or Co-Sponsored CTIMPs that requires an external service, a vendor assessment will be required.   Examples include, but not limited to:

  • Commercial and academic laboratories out with NHS GG&C
  • Bio-repositories
  • Statistical services
  • Data management services
  • Safe Havens
  • Archiving facilities
  • IMP manufacturers

In the instance that services are required from an external provider, it is imperative that the provider has been adequately vetted to ensure they can meet the needs of the trial. To this end, the Vendor Assessment process is utilised to ensure that all Vendors used within GG&C trials are capable of what is required of them.

 

The assessment is based on technical criteria relevant to the facility, in addition to evidence key Sponsor governance requirements such as:

  • GCP compliance
  • Robust Quality Management System
  • Internal Audits and SOPs
  • Relevant and up to date training
  • Safety Reporting
  • Data Protection Processes
  • Reporting of non-compliance

For further information, please contact via: [email protected]

  • Audit

The Quality Department are responsible for conducting Audits across studies and trials within Research and Innovation. This can cover a wide range of different activities, looking at studies and trials and their activities as well as procedures within the Research and Innovation department itself. Audits are a mandatory requirement within Good Clinical Practice and defined as:

 

“A systematic and independent examination of trial related activities and documents to determine whether the evaluated trial related activities were conducted, and the data were recorded, analyzed and accurately reported according to the protocol, sponsor's standard operating procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).”

 

The Quality Department provide audits as a service which is delivered to other Departments and trial teams. As such, the audits are intended not only to ensure compliance to processes and protocols but to assist those being audited by identifying and removing issues, not only within the area of focus but with associated processes. If improvements can be made to remove waste and streamline activities, Audit is the key mechanism by which this can be achieved. When issues are identified, they can be removed. The audit team will always seek to engage fully with auditees and to form a consensus as those being audited will usually be the subject matter experts. An audit is an opportunity to improve and to influence processes.

 

It is important to have an accurate understanding of what an audit is, its intended purpose and also what activity takes place that is not considered and audit, generally speaking the separation between Audits, Monitoring, Quality Checks and Inspections are:

 

What is an Audit?

  • An Audit is a systematic, documented and independent review of any trial, study or process
  • An Audit will provide a “snapshot” of a moment in time and confirm “if you are doing what you say/think you are doing”
  • An Audit is part of sponsor Quality Assurance and feeds into quality systems

 

What is not an Audit?

  • Monitoring is a continuous and systematic process throughout the lifetime of the trial conducted by clinical trial monitors not independent of the trial who have not been involved in completing the activity.
  • Inspections are Independent regulators verifying study data whose primary interest is the protection of the public, e. Medicines and Healthcare products Regulatory Agency (MHRA), Human Tissues Authority (HTA).
  • Quality Checks are a continuous and systematic process throughout the lifetime of the trial conducted by clinical trial monitors not independent of the trial who have been involved in completing the activity.

 

Beyond this, the separation between audit activity, Research and Service Evaluation is defined in the following table:

Audit/ Quality Improvement

Research

Service Evaluation

Designed and conducted to produce information to inform delivery of best care

The attempt to derive generalizable new knowledge including studies that aim to generate hypotheses as well as studies that aim to test them.

Designed and conducted solely to define or judge current care.

Designed to answer the question: Does this service reach a predetermined standard?’

Quantitative research – designed to test a hypothesis. Qualitative research – identifies/explores themes following established methodology.

Designed to answer: “What standard does this service achieve or is it complying with best practice?”

Measures against a standard.

Addresses clearly defined questions, aims and objectives.

Measures current service without reference to a standard or best practice.

Involves an intervention in use only (the choice of treatment is that of the clinician and patient according to guidance, professional standards and/or patient preference).

Quantitative research – may involve evaluating or comparing interventions, particularly new ones. Qualitative research – usually involves studying how interventions and relationships are experienced.

Involves an intervention in use only. The choice of treatment is that of the clinician and patient according to guidance, standards, best-practice and/or patient preference.

Usually involves analysis of existing data, but may include administration of simple interview or questionnaire

Usually involves collecting data that are additional to those for routine care but may include data collected routinely. May involve treatments, samples or investigations additional to routine care.

Usually involves analysis of existing data but may include administration of interview or questionnaire.

No allocation to Intervention groups: the health professional and patient have chosen intervention before quality improvement.

Quantitative research – study design may involve allocating patients to intervention groups. Qualitative research – uses a clearly defined sampling framework underpinned by conceptual or theoretical justifications.

No allocation to intervention: the health professional and patient have chosen intervention before conducting quality improvement.

 

For further guidance on and definitions to establish if your project is clinical audit, post market surveillance, service evaluation or research, please refer to:

http://www.hra-decisiontools.org.uk/research/

 

 

  • Non CTIMP training

A large number of the trials Sponsored by Greater Glasgow & Clyde are classed as non Clinical Trial of an Investigational Medicinal Product (non CTIMP), in this instance the Quality Department provides regular training sessions to support the Trial Teams in setting up and maintaining their site file. This is viewed as a preventative measure for Research and Innovation to ensure Trial Teams for Non CTIMPs are adequately trained and able to follow the required SOPs to produce the site file, this will ensure common issues which have been identified through Monitoring and Auditing activity are discussed with Trial Teams to avoid occurrence in future trials. This training session is also a useful opportunity for trial teams to ask for study specific advice on how to navigate study conduct and management at site from set up to close out.

 

Training Sessions are convened on a regular basis and the list of attendees is generated using standard extracts from the research database and asked to attend by a member of the Governance Team. The sessions are small, informal and friendly, giving researchers a chance to network with their peers, identify study related issues and challenges and participate in group discussions. 

 

The sessions are aimed at individuals employed by NHS GG&C only, who are new to research within the study team; researchers who are Chief Investigator for the first time, or Investigators new to NHS GG&C Sponsored research. Ideally, attendance should be prior to study recruitment. A sample site file index and supporting documentation is also provided prior to the training and study start up, which will be used as the basis for the session.

 

These sessions cover applicable regulatory frameworks; applications of Good Clinical Practice (GCP); good documentation practice and how each section of the site file index relates to the research.  In addition, processes that may also apply to the research are covered, i.e. amendments, study non compliances.  Common research audit findings are also discussed as exemplars of study non compliances and strategies discussed on how to avoid them.

 

Guidance, applicable legislation, responsibilities and principles of good clinical practice for researchers and research teams can be found here:

https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/uk-policy-framework-health-social-care-research/

For further information, please contact via: [email protected]

 

  • Develop and Maintain the processes within Quality Management Tool (Q-Pulse)

A standard toolset is utilised by Research and Innovation for a number of activities, the aim of which is to allow these activities to be controlled in a uniform and predictable way to make the access and sharing of information easier for all those involved.

 

Q-Pulse is a Quality Management System for the control of Audits, Corrective and Preventative Action (CAPAs), Documents, Incident & Occurrences, People and Training. It utilises a number of modules which can be tailored for the specific requirements of all the processes within R&I. The Quality Department are responsible for developing and managing the content of Q-Pulse and generating reports to informing others of  what actions are required and when.

Last Updated: 11 June 2021