PharmaSchool:
Sponsor Responsibilities for Clinical Trials
Please contact Jo Burmester at jo.burmester@pharmaschool.co.uk to find out more about in-house courses and discuss your specific needs.
Duration:
1 day
Description:
This course provides a working knowledge of the key responsibilities of Sponsors of clinical trials
Who it is suitable for:
The course is aimed at those assuming sponsor responsibility for clinical trials and is particularly useful for those who contract out the bulk of the operational aspects of the trial, or non-commercial organisations new to the role of sponsor.
Example content:
Introduction to the clinical trial process
 Clinical Trial Lifecycle
Key roles and responsibilities
ICH GCP Chapter 5
Definition of a sponsor
Sponsor responsibilities
Roles and delegation
EU Legislation
Sponsor responsibilities under EU directives
Approvals/licenses required
Local legislation where applicable
Contracts
Managing subcontractors
Key contents for contracts
Managing investigational sites
Customised In-house Courses are designed for organisations wishing
to train a group of your employees at a location of your choice.
For information about Open Courses click here or for
online learning click here
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