Based on the considerations of a risk-based Quality Management (RbQM), clinical monitoring should be planned in a risk-oriented manner. The sponsor of a clinical study should make use of the so-called “monitoring mix”, consisting of the three components.
Onsite and remote monitoring will be taken care of by the function of clinical monitors, also named Clinical Research Associates (CRAs), while central monitoring will be the task of biometricians and data managers.
To be able to plan a risk-based clinical monitoring approach for a given clinical study, the sponsor needs to evaluate and assess the risks identified during the risk analysis during the planning phase of a clinical study. The clinical monitoring approach will need to be planned and prepared based on the results of this risk assessment. It is advisable and stipulated by ICH GCP E6(R2) and DIN EN ISO 14155:2020 to develop a Monitoring Plan (MP) prior to study start defining and justifying the monitoring approach.
As a Sponsor, you should consider the following key aspects:
When planning clinical monitoring services together with a CRO, it is advisable to consider the following aspects during the planning phase:
Know your needs.
Be aware, that clinical monitoring activities can cover a wide range. Only a thorough assessment of the risks of your clinical study that are associated with data integrity and patient safety can give you an idea of the range of monitoring services to be applied.
There is no “one size fits all”.
I know that each clinical study is an individual project with individual challenges. IMP/IMD, indication, investigational sites, and regions - these are the main influencing factors of your clinical monitoring plan. As an example, inexperienced sites in a new indication will demand intense monitoring in the start-up phase and a timely response to deviations identified by the clinical monitors. Central monitoring will help the CRO trigger onsite monitoring visits and can furthermore identify problems in an early stage of the trial; however, central processes need to be well established, and the interfaces must work smoothly.
Make sure that the monitors that you engage can fulfill the specific needs of your study.
Be clear in the minimum acceptable experience of the clinical monitors that you want the CRO to be involved in monitoring activities. The risk assessment and the monitoring plan will help you to assess whether e.g., CRAs with 1-2 years of experience will be acceptable or whether >5 years of experience in monitoring might be necessary due to the expected complexity of the study or unexperienced sites.
Optimize Your Clinical Monitoring Approach with Us! Let’s discuss how our expertise in risk-based monitoring can contribute to the integrity and safety of your clinical study.
Autor: Dr. Christoph Ortland, December 2023
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