GCP for Investigators, e-course

About the course

Welcome to an e-course on Good Clinical Practice (GCP). This introductory course explains the fundamental principles and concepts of ICH GCP, with a focus on the investigator’s responsibilities. It provides you with knowledge on how ICH GCP is applied when conducting a clinical drug trial at an investigator site.

The course meets TransCelerate’s minimum criteria for ICH E6 GCP training for personnel at an investigator site. The course is given in Swedish (GCP för prövare).

Who Should Attend

This course is suited for those who have recently started, or plan to start, working with clinical drug trials and need an understanding of the various trial components and how GCP regulates a drug trial at an investigator site. The course focuses on the investigator’s responsibilities and is mainly aimed at the responsible physician/investigator. However, it is also relevant for research nurses or other support staff to whom an investigator may delegate tasks.

If you’re interested in an e-course that focuses on the practical implementation of a clinical drug trial at an investigator site, you may want to consider the e-course GCP och klinisk prövning – från studiestart till avslut.

Learning Objectives

To understand how GCP regulates the different aspects of a clinical drug trial.

Course Content

• Basic Principles
• Roles and Responsibilities
• Planning
• Agreements
• Training and Qualifications
• Delegation
• Initiation
• Recruitment of Research Participants
• Informed Consent
• Investigational Drug at the Trial Site
• Documentation
• Safety Reporting
• Monitoring Visits
• Audits and Inspections
• Closeout and Archiving
• What if the trial evaluates medical devices rather than drugs

The course is in Swedish, but quotes from ICH GCP are in English.

Övrigt

Course Certificate 
Once all elements are marked as complete, you can download a personalized course certificate. The certificate is available in the learning portal and can only be downloaded during the six months of course access.

TransCelerate Mutual Recognition 
This training 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 as necessary to enable mutual recognition of GCP training among trial sponsors.”