Course Description

ISO 14155:2011 - Clinical Investigation Close Out

Course Description:

This course explores the requirements for both premature terminations and temporary suspensions of clinical investigations. It also reviews the process of resuming routine clinical investigation close outs. 

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Learning Objectives:

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
  • 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

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/Requirements:

The following material is required:

  • A basic understanding of clinical investigations
  • ISO 14155: 2011 - Scope (ID 61)
  • ISO 14155: 2011 - Ethical Considerations (ID 62)
  • ISO 14155: 2011 - Clinical Investigation Planning (ID 63)
  • ISO 14155: 2011 - Clinical Investigation Conduct (ID 64)

Subject Matter Expert:
Danielle Giroud

20 min

Release date:

Related resources:

Case studies:

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