ISO 14155:2020 - Clinical Investigation Close Out
This course explores the requirements for both premature terminations and temporary suspensions of clinical investigations. It provides in depth review of the risk management processes to be applied when a clinical investigation is to be suspended for un-anticipated risks that occur. It also reviews the process of resuming routine clinical investigation close outs and the requirements and content of the clinical investigation report
Upon successfully completing this course, learners will be able to:
- Close down or temporarily suspend a clinical investigation in a given site or throughout all sites involved and understand the necessary activities under risk management.
- Recognize that documenting all actions is mandatory
- Take into account that the essential documents referred to in Annex E of ISO 14155 must be kept in a traceable manner for a period of time determined by regulatory authorities
- Understand the contents of a clinical report
- Apply the necessary regulatory steps such as integrating the report in the technical file and update necessary related risk management documents.
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.
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)