ISO 14155:2020 - Responsibilities of Sponsor
ISO 14155:2020 - Responsibilities of Sponsor
This course examines the roles and responsibilities of the sponsor and monitor during clinical investigations.
It covers the following topics:
- Major areas of responsibility
- Specific sponsor responsibilities with clinical quality assurance, quality control, and outsourcing
- General work flow
- Preparation and planning of clinical investigations
- Monitoring and safety handling during clinical investigations
- Communication with regulatory authorities
ID: N184
45 minutes
2 modules
€ 161.00
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Learning Objectives
Upon successfully completing this course, learners will be able to:
- Monitor responsibilities during the setup, conduct, and close out of clinical investigations
- Be informed of whether the sponsor wants to outsource any functions or duties
- Understand that any outsourced work remains the sponsor’s primary responsibility
- Ensure all appropriate sub-contractor agreements are in place before the outsourcing process begins, including sub-contractor performance checks
- Understand Sponsor’s responsibilities throughout the clinical investigation up to closure.
Who Should Enroll
Clinical research associates (monitors), clinical study coordinators, assistant senior clinical research associates, clinical project and data managers, data entry personnel, ethics committee and institutional review board members, regulators, and notified body personnel involved in auditing clinical evaluations are all welcome to participate in this course.
Prerequisite Knowledge
The following material is required:
- A basic understanding of clinical investigations
- ISO 14155 - Scope (IDN158)
- ISO 14155 - Ethical Considerations (IDN175)
- ISO 14155 - Clinical Investigation Planning (IDN176)
- ISO 14155 - Clinical Investigation Conduct (IDN177)
- ISO 14155 - Clinical Investigation Close Out (IDN178)