This 1-day course on Clinical Service Provider Audits will allow you to:
- Consider the types of risk associated with the engagement of clinical service providers in the conduct of clinical trials
- Understand sponsor oversight of clinical service providers
- Develop a risk based clinical service provider audit program
- Plan for successful clinical supplier audits
- Conduct and report clinical supplier audits
The course includes cases studies, short exercises and a final evaluation to encourage understanding.
Clinical Service Provider audits are a valuable addition to your company audit and supplier oversight program. In the new ICH GCP E6 R2 world, sponsors are required to maintain oversight of the activities they delegate to clinical service providers by adopting a risk-managed approach to clinical trials, including audits. The volume of outsourcing by the pharma and biotech industries along with huge variety in clinical service providers, can make the life of the QA group difficult when trying to decide who to audit and when.
The conduct of clinical supplier audits can be challenging as they require;
- An understanding of the company outsourcing strategy
- An awareness of the service providers being used, the services they provide and how the trials are managed
- An ability to assess the impact of the clinical service suppliers on the successful completion of the trial
Clinical auditors and outsourcing professionals will need to have the skills and confidence to embrace these challenges and understand the concept of clinical service provider audits and their application in the delivery of high quality audits.
This course provides you with the grounding that will allow you to become familiar with the impact clinical service providers can have on the successful execution of clinical trials and the key aspects of planning, preparing, developing, conducting and reporting clinical service provider audits.
Course time09h00 - 17h00
Who should attend
Clinical auditors, other quality professionals engaged in the process of outsourcing clinical research activities.
Individuals should have at least 1-2 years’ experience in clinical auditing or in the selection and qualification of clinical service providers.
- Who are clinical service providers
- How to assess the risks associated with your clinical service providers
- ICH GCP E6R2 and sponsor oversight
- Quality Agreements, Key Risk Indicators and Metrics
- Risk managed approach to the clinical service provider audit program
- The pros and cons of when to audit
- How to engage with your clinical service provider
- Planning for successful audits
- How to maintain control of your clinical service provider audit
- Reporting and follow-up of clinical service provider audits
- Common challenges observed at audit
- Appreciate the role of clinical service providers and the associated risks
- Understand how a risk managed audit program can support the sponsor oversight activities
- Be able to plan, conduct, report and follow-up a clinical service provider audit
This course covers competencies that are part of the ECCRT Competency Framework
- Scientific Concepts & Research Design ()
- Ethical & Participants Safety Considerations ()
- Investigational Product Development and Regulation ()
- Clinical Studies Operations (GCPs or ISO 14155) ()
- Study and Site Management ()
- Data Management and Informatics ()
- Leadership and Professionalism ()
- Communication ()
- Teamwork ()
- Business acumen ()
Be aware that attending one of ECCRT open course does not guarantee that the competency is acquired but only guarantees that the related knowledge has been trained