Clinical Research
GCP Quality Assurance for Clinical Research
Good Clinical Practice quality assurance for staff working on clinical trials and at research sites, covering site readiness and trial documentation.
- Level
- Core
- Delivery
- Online (live)
- Certification
- Nestra Klinikal Certificate in GCP Quality Assurance
Who this is for
- Clinical research associates and coordinators
- Research site quality and regulatory staff
- Laboratory staff supporting clinical trials
What you will be able to do
- Apply GCP requirements to day-to-day site activity
- Maintain a trial master file that withstands inspection
- Prepare a research site for sponsor and regulatory audit
Curriculum
- 01
GCP principles
The ethical and scientific basis of the standard.
- 02
Site responsibilities
Investigator and site staff obligations.
- 03
Documentation and the trial master file
What must be kept, for how long, and in what condition.
- 04
Audit and inspection readiness
Preparing for and hosting an audit.
Entry requirements
- Involvement in, or intention to work in, clinical research