FAQ’s – Quality Assurance

• Good Clinical Practice, or ‘GCP’ is the ethical, scientific and practical standard that clinical research is held to.

• It is an internationally recognised standard for the design, conduct, recording and reporting of clinical trials involving human participants.

• It is considered best practice for all clinical research but it is a legal requirement for Clinical Trials of Investigational Medicinal Products (CTIMPs)

• All staff named on the delegation of duties log for a Clinical Trial of an Investigational Medicinal Product (CTIMP) must have GCP training every three years.

• Staff involved in any other research study at CNTW are encouraged to complete GCP training as good practice. Where 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 within their CV and any study specific training logs or certificates.

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

GCP training can be accessed on the NIHR Learn Website. If you are not registered you can create an account and access all online training here.

Data should only ever be stored in accordance with GDPR, your IRAS form and/or other regulatory approval documentation and reflecting the information provided to participants in their Participant Information Sheet (PIS) and Informed Consent Form (ICF). The practicalities of the proposed data storage method should be considered prior to submitting for approval e.g. whether your organisation is able to password protect folders and/or documents stored electronically. Patient identifiable data should always be stored separately from sensitive data such as study outcomes and assessments documented within Case Report Forms (CRFs).

First Participant Audits are carried out by the Quality Assurance Lead on some studies at CNTW dependent on a risk-graded assessment. This is an informal opportunity to iron out any potential site file issues at an early stage in the study. When the first participant has been consented and/or recruited into a study, R&D should be notified of this. Where appropriate, the QA Lead will then be in contact to arrange a First Participant Audit with you.

• Prior to submitting your study for approval, documents should be version controlled as Draft – V1 – date. Subsequent draft versions should be labelled as Draft – V2 – date; Draft – V3 – date etc.

• When submitting your study for approvals (e.g. via the HRA/NHS REC) the version of your document should be V1 – date. Subsequent amended versions should be labelled as V2 – date; V3 – date etc.

• Previous version of study documents should be superseded by striking a line through the document, noting the date that the document was superseded by a new version, and initialling.

• Depending on the risk associated with a particular study, a number of different methods may be used to conduct an audit.

• On-site Audits include study facilities and documentation, participant documentation, electronic health records (EHRs) 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 (PIS) and regulatory and ethical approvals.

• Remote Audits will include study and participant documentation, EHR and study staff documentation as with On-Site Audits. However, these will be conducted with the auditor remotely via MS Teams and it is expected that the researcher would have access to the TMF/ISF to be able to provide the auditor with the requested information throughout the audit.

• A Self-Assessment Audit is utilised for lower risk studies and involves the researcher completing a Self-Assessment Checklist and returning to the auditor for review. The auditor may then request follow up information and/or look at EHRs for participants independently. If the Self-Assessment Audit raises any concerns, or if researchers do not engage with the process, this may result in an escalation to another audit method.

• What documentation do I need for an audit?

• It is expected that the researcher has 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. You can request a copy of the applicable index via [email protected] to aid your document management and/or preparation for an audit.

As a minimum, the following studies are audited annually at CNTW:

• All studies sponsored by CNTW
• All hosted Clinical Trials of Investigational Medicinal Products (CTIMPs)
• All hosted Medical Device Trials
• 10% of the remaining hosted studies open to recruitment, selected as a result of a risk-graded assessment
• When the first participant is recruited into a study where deemed appropriate depending upon a risk-graded assessment

Additionally, study teams can request ad hoc audits where they feel this would be helpful by emailing [email protected]. The QA Lead may also audit studies if there is suspicion of non-compliance by those conducting the study.

A First Participant Audit is conducted for some studies running at CNTW dependent on a risk-graded assessment. This is an informal opportunity to iron out any issues with the study documentation at an early stage of the study following the first participant being recruited.