Course Description

Selecting Investigation Sites

Course Description:

This course illustrates the steps involved in site qualification, a mandatory phase for sponsors before they can commit to working with a particular investigator or institution.

It covers the following topics:

  • Practical instructions on how to perform investigation site selections
  • Essential tools
  • Pertinent questions
  • Ensuring all players on the site are in agreement
  • Remediating deficiencies before deciding whether or not the clinical investigation site should participate in the study Examples and case studies demonstrating how to handle difficult situations

Learning Objectives:

Upon successfully completing this course, learners will be able to:

  • Define criteria for qualifying investigation sites, including preparing qualification lists
  • Conduct a qualification process, including the preparation, management, and follow-up of a qualification visit
  • Assist the study manager in making appropriate decisions on whether or not to include a given investigator or institution

Who Should Enroll:

Monitors, clinical project managers, investigators, study coordinators, quality assurance, regulatory, and marketing professionals involved in the site qualification process, and pharmaceutical clinical professionals wanting to understand the differences in medical device site qualifications are all welcome to enroll in this course.

Prerequisite Knowledge/Requirements:

A thorough knowledge of the elements involved in the preparation of clinical investigations, including the basics of good clinical practice for medical devices, clinical investigation plans, the informed consent process, and the EC and IRB processes is required.

Subject Matter Expert:
Danielle Giroud

45 min

Related resources:

Case studies:

Basic Account: € 146.00
Premium Account: € 110.00

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