OUTSOURCING


Clinical activity assessment Activity


Monitoring


Representative questions to be asked to determine status


 Who conducts monitoring and evaluation of performance and oversight  SDV philosophy  Risk-based methodologies  In which regions/counties are studies conducted


Internal workflow


 Is it standardised across ClinOps  Are they electronic windows – do they work and have they increased efficiency


 Has an assessment of process application been performed  How is knowledge managed – for example, study lessons learned, therapeutic knowledge, non-controlled study templates


Process


 Has a fit for purpose analysis been performed  Are the processes up to date  Has an E6 R2 analysis been performed and acted addressed  Have there been any inspection findings related to process during the past three years


 What electronic system is in place to oversee data, safety and regulatory compliance


 Have there been any critical or major findings during the past three years


Inspection/audit findings


 What are the top five inspection findings  Are internal process audits conducted – if so, which processes, when, and what are the results


Once we establish the basic clinical compliance staffing requirements, we next perform a ClinOps analysis concentrating on process efficiency, understanding current challenges and compliance with E6 R2, and other relevant regulatory bodies. The table above outlines several examples of activities typically important within a ClinOps function and representative questions that may be asked to understand, and determine the current operational and quality status. It is recommended that you first look at the action


plan from a high level and subsequently develop a detailed project plan. However, no matter how this is approached, the development and ongoing management of a ‘change management plan’ is highly recommended.


Identification Prevention


To identify or set up systems to identify the risks that ClinOps faces.


To design and implement controls to protect an


organisation from those risks.


In the past, we have used the following two-step


approach for our initial action planning: an action plan and a plan for staffing and growth of the compliance group.


Finalise departmental design The proposed clinical compliance areas of concentration – in the figure below – consists of risk identification, prevention, monitoring and detection, and resolution, along with the establishment of a compliance advisory role. It is crucial to set up a strategy to address each of these categories; the following is a suggested approach to address these key areas.


One approach is identification, the objective of which is to set-up systems or capabilities to identify


Monitoring & detection


To monitor and report on the effectiveness of those


controls in the management of an organisation’s exposure to risks.


Resolution To lead or


participate in the resolution of compliance difficulties as they occur.


To advise the business on risks and controls.


Advisory


Outsourcing in Clinical Trials Handbook | 39


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