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monitoring audit and inspection

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Monitoring, Audit & Inspection

The majority of sponsor oversight is achieved by central monitoring and information management systems; and where third parties are involved this also includes the monitoring of activities delegated out through executed contracts.  Noclor may also schedule face-to-face meetings with the Chief Investigator throughout the study; these sponsor oversight meetings provide the opportunity for both parties to update on progress, review milestones, flag up any concerns/unforeseen risks and agree action plans.  The requirement for (and frequency of) sponsor oversight meetings will be discussed with the Chief Investigator at the time the sponsorship request is reviewed (as part of the risk assessment) and will be proportionate study design/identified risks.  All meetings should be minuted and records retained by the Chief Investigator in the Study/Trial Master File (S/TMF).

Noclor operates a centralised model for quality management of the research activities by its partners to ensure oversight is maintained from the outset.  Noclor guidance and instructions apply to all stages of the research life-cycle for all research studies that are sponsored by a Noclor partner.  

All sites and third parties participating in a research study sponsored by a Noclor partner agree (through signed agreements) to the data and documentation pertaining to that study being made available on request for the purposes of monitoring, inspection or audit.

Monitoring

Monitoring is designed to verify the quality and safety of a study and ensure that it is conducted, recorded and reported according to the protocol (and any conditions of approval or subsequent amendments), written procedures, GCP and the applicable regulatory requirements.

The monitoring requirements for a study should be considered early on in the study development and incorporated in the protocol (as there may be cost implications). The protocol and risk assessment will be used to inform the overall approach for sponsoring and managing a specific study. Clinical trials are likely to have additional monitoring requirements and these will need to be documented in a study-specific monitoring plan.

Where there is a requirement for a study-specific monitoring plan for a study this must developed and agreed by Noclor and the Chief Investigator prior to study activation. The monitoring plan should clearly define the elements of the study that require monitoring and the method that will be used to monitor.  The monitoring plan will be amended as required, for example, if new risks are identified during the trial.

There are a number of different approaches that can be used to monitor; the type and combination of monitoring activities will be adapted to suit a particular trial.

Monitoring activities (of specific research studies as opposed to system-based monitoring activities) should be conducted by someone who is familiar (trained) in the protocol and all other applicable documents, procedures and the relevant regulatory requirements. This will usually be the responsibility of the dedicated trial manager, however Noclor may perform monitoring activities directly themselves or outsource to a third party (such as a CRO or freelance monitor).

All monitoring activities performed must be documented and retained in the Study/Trial Master File (S/TMF)

Noclor maintains oversight by conducting various central monitoring activities.  This allows Noclor to assess what is happening as it is happening (real-time);  pick up on trends, potential red-flags and unforeseen risks (i.e risks that were not identified at the initial risk assessment) so that the necessary preventative or escalation measures can be initiated. 

Audit

Audits are used to check and evidence that the Noclor quality management systems are working (assessment after the event); providing assurances that sponsored research is compliant to the protocol, Noclor procedures, GCP, relevant guidelines and/or legislation whilst at the same time identifying any gaps or failures within the system (and where improvements can be made or further training/clarity of process is required).

Noclor apply a risk-based approach to the frequency and nature of audit activities of sponsored research.  Audits may be triggered as a result of a potential red-flags that require further investigator (i.e  review of minutes of a meeting, a monitor report or email correspondence that raises concern or a formal complaint) or as part of a routine review of  sponsor oversight systems (where a site or study maybe selected for audit or one particular area across all sponsored studies will be audited (such as consent or document version control)). 

Audits are conducted by personnel independent of the study team (where the audit is of a site or study activity) and the auditor must be able to demonstrate that they have expertise relevant to the area being audited (for example: if auditing a CTIMP the auditor should be able to demonstrate a sound working knowledge of the current legislation so that they can assess whether the organisation is meeting the requirements of the legislation).

Where a site is selected for a Noclor audit they will be contacted to arranged a convenient date and then the audit will be conducted according to the following basic programme:

  • Introductory Meeting
  • Review of Investigator Site Files (ISF)
  • Interviews with key study personnel (which must include the Principal Investigator)
  • Review of CRFs and other documents and check against source records
  • Visit to laboratory/pharmacy (if applicable)
  • Audit close out meeting

Audits will be written up by the auditor and reported to Noclor within agreed timeframes.  Noclor will disseminate audit reports as appropriate to other parties.  Signed audit reports and correspondence should be retained by the Chief Investigator in Study/Trial Master File (S/TMF)

Where a study sponsored by a Noclor partner is selected for internal audit by the host site (Trust R&D), the Noclor Sponsor Representative should ideally be notified in advance of the audit. A copy of the audit report should be provided for review by Noclor (as this may flag up non-compliance or issues that are study-wide as opposed to site-specific and left unreported may escalate to serious breaches ) and retained by the Chief Investigator in Study/Trial Master File (S/TMF).

If a site or member of the research team is notified of audit of a study sponsored by a Noclor partner by any party other than Noclor or the host site, the Noclor Sponsor Representative should be informed immediately by calling 020 3317 3757 (prior to the audit being conducted). 

Inspection

Clinical Trials that are within the scope of The Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 1031) as amended may be subjected to MHRA inspection. UK Inspectors have statutory rights; these include the rights to enter premises involved in CTIMPs to carry out inspections, take samples, request documentation and take copies of the documentation and to seize substance, articles and documents. It is a criminal offence to obstruct an inspector during a statutory inspection.

The types of inspection that may be conducted that are applicable to non-commercial research are:

  • Routine system inspection – these are scheduled inspections and the organisation would be notified in advance. Inspectors may select a number of trials to test the systems of an organisation or one study and that tests how procedures are applied in practice (this may involve selecting external sites or vendors involved on the trial)
  • Triggered inspection- as a result if information received by the MHRA. In these circumstances the organisation may receive little or no notification of the inspection

If a third party (host site or vendor) is notified of a statutory/triggered MHRA inspection of a clinical trial that is sponsored by a Noclor partner, the Noclor Sponsor Representative should be notified immediately by calling 020 3317 3757, as Noclor may need to assign specific resources to assist with the inspection preparation or advice on a particular course of action.

We appreciate that inspections can be stressful for all those personnel involved; in the event of your sponsored study being selected for inspection rest assured that the Noclor team will be here to support you throughout the process. Try to see the inspection process as an opportunity to demonstrate compliance (we should be inspection-ready at all times) and use the process as a learning experience (working with the inspectors to further improve our systems).