Learning outcomes

Upon completion, students will be able to:

• Understand the challenges of conducting clinical trials across multiple countries and regions.

• Apply effective project management techniques in an international context.

• Monitor and manage global studies using risk-based approaches

Goals

This course provides participants with the knowledge and practical skills needed to manage and monitor international clinical trials.

Content

Module 1: International Project Environment

Module 2: Monitoring of clinical trials

Module 3: Budgeting in global studies

Exercices

The course will include different learning Activities:

  • Case studies and role-playing
  • Group discussions
  • Real-world examples

Teaching methods

PowerPoint presentation will be used during classes - will be made available on Webcampus.

Assessment method

Written exam

Multiple-choice questions based on selected module

Sources, references and any support material

Recommended Reading Material:


• Regulation N° 536/2014 on clinical trials on medicinal products for human use, repealing directive 2001/20 EC - 16 April 2014: http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2014.1…

• EU directive 95/46/EC on the protection of individuals with regard to the processing of personal data and on the free movement of such data: http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=URISERV:l14012

• What makes clinical research ethical? Ezekiel J. Emanuel and all; JAMA May 24/31, 2000 – Vol. 283 N°20

• Reflection paper on ethical and GCP aspects of clinical trials of medicinal products for human use conducted in third countries and submitted in marketing authorisation applications to the EMA. (http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/…

• Global Clinical Trial Liability Insurance By Frank Goudsmit in Journal of Clinical research Best Pratices Vol. 9, No. 2, February 2013.

• GENERAL PRINCIPLES FOR PLANNING AND DESIGN OF MULTI-REGIONAL CLINICAL TRIALS E17 Current Step 2 version dated 6 May 2016 (http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Ef…

• INTEGRATED ADDENDUM TO ICH E6(R1): GUIDELINE FOR GOOD CLINICAL PRACTICE E6(R2) STEP 4 NOVEMBER 2016 (http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Ef…

• Ensuring compliant TMF practices: common regulatory inspection pitfalls and how to avoid them. Sarah Ray, Senior Research Analyst at Cutting Edge Information. Cutting Edge White paper

• FDA Guidance: Use of Electronic Informed Consent, Questions and Answers. (https://www.fda.gov/downloads/drugs/guidances/ucm436811.pdf

Language of instruction

English