Clinical Trials - Introduction

About the Course

Our introductory course in clinical drug trials is one of our most popular offerings. Over the years, many have started their journey into clinical trial work with us at Läkemedelsakademin. This course is also a valuable place to start building a network with others in the field. The course is given in Swedish (Kliniska prövningar – grundkurs).

Who Should Attend

This course is designed for everyone working with clinical trials in the pharmaceutical industry, healthcare, academia, and pharmacy. It is primarily aimed at those who have recently started in the field; however, it is open to participants of all experience levels.

Learning Objectives

This course offers an overview of clinical trial work and relevant regulations, including Good Clinical Practice (GCP). By the end of the course, you will have gained knowledge in planning, conducting, closing, and meeting quality standards for a clinical study. You will also have a strong foundation for further professional development in the field.

Course Content

• Introduction to Clinical Drug Trials and the Clinical Trial Protocol
• Current Regulations for Conducting a Clinical Trial
• Planning a Clinical Study
• Statistical Aspects of Study Design
• Applications
• Initiation Visit
• Conducting Clinical Trials
• Study Closeout and Reporting

Preparing for the course

About one month before the course begins, you will gain access to our introductory e-course: GCP and Clinical Trials from Study Start to End. The e-course takes approximately 1-3 hours to complete, depending on your prior knowledge, and it is recommended that you complete it before the in-person course starts.

Meets the minimum criteria for TransCelerate GCP training

This ICH E6 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma, Inc. as necessary to enable mutual recognition of GCP training among trial sponsors.