Quality Assurance is an integral part of safely conducting research. We must ensure that patients are given opportunities to participate in high quality, ethical research, while protecting the integrity of the data collected.

Researchers are expected to follow

  • Local, national, and international guidance and regulatory and legislative requirements.
  • Principles of Good Clinical Practice. (This is the internationally recognised standard for the design, conduct, recording and reporting of clinical research involving human participants.)
  • Sponsor's Standard Operating Procedures (SOPs), and any study-specific SOPs and guidance documents.

Research hosted and sponsored by CNTW is subject to audit and monitoring procedures. How often these happen, and what is required, is determined by a risk-graded assessment.

If you have any questions about ensuring quality assurance compliance in your research at CNTW, please contact us at research@cntw.nhs.uk. 

Good Clinical Practice (GCP) training

All staff named on the delegation of duties log for a Clinical Trial of an Investigational Medicinal Product (CTIMP) must have Good Clinical Practice (GCP) training every three years. Where there are significant changes to the content of GCP training, you may be asked to refresh your training earlier. 
Staff involved in any other research study at CNTW are encouraged to complete GCP training as good practice. 

Complete GCP training on the NIHR Learn Website.

If GCP training is not completed, all staff on the delegation log must have documented evidence that they are appropriately trained and qualified to undertake the research activities delegated to them. This might be demonstrated by their CV and any study-specific training logs or certificates.

The Chief Investigator or Principal Investigator is responsible for ensuring that the study team have received all necessary training to allow formal delegation of duties and responsibilities.

Audits

As a minimum, we audit the following studies each year:

  • All studies sponsored by CNTW open to recruitment and follow-up (to include 5% of national locations of regulated trials open at the point of audit). 
  • All hosted CTIMPs open to recruitment and follow up.
  • All hosted Medical Device Trials open to recruitment and follow up.
  • At least 5% of the remaining interventional hosted studies open to recruitment and follow up, selected as a result of a risk graded assessment.
  • Sponsored and hosted regulated trials, shall be subject to a first participant audit following the first participant recruited to the study. 

Study teams can request an ad hoc audit if they feel this would be helpful, by contacting research@cntw.nhs.uk. 

The Deputy Research and Development Manager may also audit studies for cause if there is possibility of non-compliance.

Depending on the risk associated with a particular study, we may use a number of different methods to conduct an audit:

  • On-site Audits include study facilities and documentation, participant documentation, electronic health records, and study staff documentation. This would include checking that the appropriate approvals are in place for a study, and that all staff are suitably qualified to undertake their delegated roles. Additionally, an On-Site Audit would involve ensuring that participants have been provided with the correct study information, and that their data is stored appropriately in accordance with the Participant Information Sheet and regulatory and ethical approvals.
  • Remote Audits will include study and participant documentation, electronic health records, and study staff documentation, as with On-Site Audits. However, these will be conducted with the auditor remotely. 
  • Self-Assessment Audits are used for lower-risk studies. This involves the researcher completing a Self-Assessment Checklist and returning it to the auditor for review. The auditor may then request follow up information and/or look at electronic health records for participants independently. If the Self-Assessment Audit raises any concerns, or if researchers do not engage with the process, we may escalate to another audit method.

We expect researchers to have access to the Trial Master File (TMF) or Investigator Site File (ISF), and that this should contain the essential documents as outlined within our TMF/ISF Index, to be able to provide the auditor with the requested information throughout the audit. (Email research@cntw.nhs.uk to request a copy of the applicable index to support your record management and/or preparation for an audit.)
 

First Participant Audits are carried out by the Deputy Research and Development Manager on some studies at CNTW dependent on a risk-graded assessment.

This is an informal opportunity to iron out any potential issues at an early stage in the study.

When the first participant has been consented and/or recruited into a study, please tell us (research@cntw.nhs.uk). Where appropriate, the Deputy Research and Development Manager will then contact you to arrange a First Participant Audit.