OUTSOURCING Quality management system elements Evidence of functioning QMS QMS Element Success indicator


 Scheduled/planned audit and QC process


Process


 SOPs biennial review  E6 R2 gap analysis performed  Methodology to be aware of regulatory updates in applicable regions


Risk management


 Ongoing identification, processing and communication of risks that matter


 Risk management processes (for example, SOPs) in place


 Risk management system in place Issue management


 Ongoing identification, processing, communication of issues that matter


 Issue management system in place


 All issues captured and adequately addressed (action plans developed and implemented)


 System usage metrics related to review within the acceptable range (per plan)


the risks that ClinOps faces, such as data risks, operational risks, safety risks and regulatory risks. The prevention strategy aims to protect ClinOps


from risks by designing and implementing controls and/or systems, such as Clinical QMS, elements, process development and metrics/KPIs. Monitoring and detecting observes and reports on the effectiveness of controls in the management of ClinOps exposure to risks, such as risk tools, metrics, dashboards and compliance QC programmes. Another objective is to lead or participate in


the resolution of compliance difficulties as they occur, such as CAPA participation and its outcome, as well as audit participation and outcome. Lastly, the advisory approach is to advise the business on risks and controls, such as ClinOps quality meetings, inspection/audit/CAPA support and general compliance support. In the table above, we present some basics used


to determine success and measure control, and offer examples of the elements noted in our QMS design. The success indicators are those processes, tools and systems, for example, required to drive successful implementation of the QMS elements. The control indicator will measure its success and understand if the element is under control.


The table is only an example – while it does provide sufficient examples of one method used


40 | Outsourcing in Clinical Trials Handbook


to plan and measure success, the elements and measures used should be adjusted in line with your function’s priorities and compliance design.


Implementation and ongoing management Now that we understand our needs, design, measurements, staffing and priorities, it is time to put all of this into practice and develop the capability. Although many of you will probably have your methods to implement a clinical compliance group, the following are some of the basic ideas we have found to be useful:  


establish a baseline


develop charters for major capabilities as appropriate


  


formulate plans to onboard required systems, metrics, and dashboards based upon the agreements made during the development phase issue management


dashboards and metrics


ongoing compliance support. This only scratches the surface of activities that


are involved with setting up a successful clinical compliance function and Clinical QMS. We hope readers will use this as an entry point and build upon the basic concepts and proposed processes.●


Control indicator


 Audit and QC results: No critical findings, <2 major findings


 E6 gaps are addressed within a process, metric, tracker or template


 All risks that matter should be adequately controlled and reviewed per plan


 Audit and/or QC of risk process: no critical findings, <2 major findings


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