Goverment oversight trial#
A thorough risk assessment of the trial should be conducted to identify the risks and then determine the strategies and procedures to mitigate them. those activities/data that, if incorrect, would have a negative impact on participant safety and trial results. It is recommended that a proportionate approach to the management and monitoring of the trial is undertaken based on the trial risk assessment that identifies the areas that matter to achieving the above key aim, i.e. The key aim is to ensure the rights, safety and wellbeing of the trial participants are protected and that the final results of the trial are reliable. Such an approach has been used traditionally and is extremely resource intensive. Monitoring may aim to assess compliance with every detail of the protocol and trial procedures and conduct checks of every data point for consistency with source documents and validity. Important factors in determining the oversight and monitoring strategy
The auditor would also assess the effectiveness of the monitoring activities and compliance with the processes outlined in the protocol/monitoring plan/SOPs. AuditĪudit activities are sample based and may occur during or after the trial is completed, or for cause in response to issues detected by monitoring activities. Non commercial trials have primarily taken a more centralised approach to monitoring activities with less reliance on on-site visits. Traditionally, “monitoring” has tended to focus on monitors visiting sites as part of quality control and this approach has been extensively used by commercial sponsors consisting of regular on-site visits covering the activities outlined in ICH GCP guidance. Effective monitoring may also provide an opportunity for feedback to the sponsor for process improvement. Monitoring is one of the key mechanisms whereby the sponsor can be assured that it is in compliance with the legislations, and the trial protocol/procedures. Oversight would usually involve assessment of the processes that are to be used by those delegated parties, regular review meetings with personnel, review and approval of specific documentation (such as site visit report, regulatory green light documentation) or perhaps visits or co-visits to investigator sites and audit. The delegated parties would typically be implementing some or all of the detailed processes decided from the monitoring strategy.
The sponsor should be approving documents and processes implemented to carry out the delegated functions such as (not exhaustive): The sponsor’s project management or governance should have sufficient processes in place to verify that the functions are being conducted appropriately. Oversight is important where the sponsor has delegated functions to other parties, either within the same organisation (for example, to a Chief Investigator within the Trust) or to an external CRO. sponsor with Contract Research Organisation (CRO)/Chief Investigator).Īudits and visits to the investigator site by a trial monitor and auditors to assess the conduct of the trial is considered to be part of oversight.
Oversight and monitoring activities can include a broad range of activities, for example
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