Quality Assurance is an important part of safely conducting research. We must make sure that we give people chances to take part in high quality, ethical research, while protecting the integrity of the data collected.

We expect Researchers to follow:

  • Local, national, and international guidance and regulatory and legal requirements.
  • Principles of Good Clinical Practice. (This is the internationally recognised standard for designing, conducting, recording and reporting clinical research involving human participants.)
  • The Sponsor's Standard Operating Procedures (SOPs).
  • Any SOPs and guidance documents specific to the study.

Research hosted and sponsored by CNTW is subject to audit and monitoring procedures. We use a risk-graded assessment to decide how often these happen and what is required.

If you have any questions about ensuring quality assurance compliance in your research at CNTW, please contact 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. f there are significant changes to the content of GCP training, we may ask you to refresh your training earlier.

We encourage staff involved in any other research study at CNTW 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 evidence that they are properly trained and qualified to undertake the research activities delegated to them. They might demonstrate this using 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 ask for 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:

  • On-site Audits include study facilities and documentation, participant documentation, electronic health records, and study staff documentation. This includes checking that the right approvals are in place for a study, and that all staff are suitably qualified to undertake their delegated roles. An On-Site Audit also checks 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 include study and participant documentation, electronic health records, and study staff documentation, as with On-Site Audits. However, these checks will be done by the auditor remotely.
     
  • We use Self-Assessment Audits for lower-risk studies. The researcher comples a Self-Assessment Checklist and returns it to the auditor for review. The auditor may then ask for 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). This should contain the essential documents as outlined within our TMF/ISF Index, to give the auditor 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.)

The Deputy Research and Development Manager will carry out First Participant Audits on some studies at CNTW. We use a risk-graded assessment to select studies to be audited.

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

When you have consented and/or recruited the first participant into a study, please email research@cntw.nhs.uk. The Deputy Research and Development Manager may then contact you to arrange a First Participant Audit.