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Background
Over the past few years in the UK there have been significant developments in inspection risk management and the strategies of a number of regulators were reviewed by the MHRA.
It is considered that the scope, frequency and depth of inspections should be dependent on how the regulated organisation takes responsibility for compliance with the regulations. While the company or organisation has always had legal responsibility for compliance, the notice of inspection has for some been a trigger for compliance assessment instead of a continuous compliance programme being in place.
Good Clinical Practice (GCP) - Risk-based inspection process
The GCP risk-based inspection (RBI) process was launched in May 2009 and was implemented from October 2009. It uses a combination of information provided to the MHRA on the Compliance Report, internal information about previous inspection history, organisational changes and other compliance reports with the results of intelligence gathering to determine an organisation’s control of their risk.
The resulting risk assessments will be categorised into high, medium and low risk and inspections prioritised for the companies with the highest risk category. For internal control purpose, a small proportion of organisations from the medium and low-risk categories will be randomly selected for inspection. Inspections will be scheduled according to how much inspection resource is available in the upcoming year and the results of the compliance report used to determine an approximate amount of inspection time required to conduct the inspection.
Completion of the Compliance Report by sponsors, contract research organisations (CROs) or hosting sites is not mandatory. These organisations, however, should be aware that failure to submit a completed Compliance Report will result in being assigned to a high-risk category. Currently, phase 1 units, clinical labs and individual investigators not acting as sponsors of clinical trials are not required to complete a Compliance Report.
The results of the risk assessment will be provided to the organisation. If there are any concerns regarding the risk assessment this should be send to the GCP risk-based inspection mailbox (gcpriskbasedinspections@mhra.gsi.gov.uk).
Compliance report
Organisations engaged in clinical trials will be encouraged to complete a Compliance Report as a biannual activity. The MS-Excel versions of the Compliance Report can be found on the right hand side of this page for download. The Compliance Report contains detailed guidance on the terms used in the questions. The Compliance Report should be returned to the GCP risk-based inspection mailbox in electronic form.
Feedback has been received via stakeholder meetings, individual queries and comments from Compliance Reports. The frequently asked questions (FAQs) have been revised to address ambiguities and misunderstandings.
Inspection process
Once the risk assessment has been determined and an inspection scheduled, the organisation to be inspected will be contacted and requested to complete a GCP Inspection Dossier as previously. The reason for continuing with provision of the dossier is that it contains the detailed information about how the organisation operates, which is used for inspection preparation rather than scheduling. The inspection will be undertaken as previously and will conclude as usual with a closing meeting where findings will be verbally reported to the organisation. Further information on the inspection process can be found on the GCP web page.
Any questions or comments on risk-based inspection should be addressed to the GCP risk-based inspection mailbox (gcpriskbasedinspections@mhra.gsi.gov.uk) in the first instance.
Major updates
The GCP RBI process has now been implemented for two years. In order to streamline the process and reduce the burden to stakeholders, the following major changes have been made:
- Compliance Reports are only required to be submitted once every two years. There is no need to provide a CR in June 2011 if your organisation has submitted a CR in the last 12 months, if your organisation has been inspected between 1 July 2010 and 30 June 2011 (excluding investigator site inspections) or your organisations have a confirmed GCP inspection between July 2011 and September 2011.
- Hosting sites (trial sites not acting as a sponsor of a clinical trial) with less than 20 non-commercial clinical trials in IMP are not required to submit a CR.
What should UK clinical trials organisations do next?
Step 1: Download MS-Excel® versions of the Compliance Report from the MHRA GCP web page.
Step 2: Complete the Compliance Report (someone within the organisation should have specific responsibility for this task to avoid duplicate submissions).
Step 3: Submit the completed Compliance Report electronically to gcpriskbasedinspections@mhra.gsi.gov.uk by 30 June 2010. Questions about the Compliance Report should also be submitted to the mailbox. Please also provide the completed Excel file even when you submit scanned documents or pdf files.
