Customised In-house Courses are designed for organisations wishing to train a group of your employees at a location of your choice.
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
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