Brookwood Global Online Training Brochure 2024

Contents	2
Introduction	3
Fundamentals of GCP	4
The Clinical Trial Master File Essentials	5
GCP for Sponsors	6
Essential GCP for Sponsors	6
GCP Refresher for Sponsors 1 – tallest buildings challenge	6
GCP Refresher for Sponsors 2 – inspection challenge	6
GCP for Investigators	7
Essential GCP for Investigators	7
GCP Refresher for Investigators 1 – tallest buildings challenge	7
GCP Refresher for Investigators 2 – inspection challenge	7
Are you ready for … a GCP inspection?	8
Risk Management in Clinical Trials	8
GCP for Clinical Data Management	8
Pharmacovigilance (PV)	9
Are you ready for … a PV inspection?	9
PV for ALL	9
Essential PV – Know PV	9
PV for the Local Safety Contact and L-QPPV	10
PV Refresher	10
Essential Safety Reporting for the Investigator Site	10
Non-interventional studies (NIS)	11
Non-interventional Studies, General Principles (Module 1)	11
NIS, Practical Aspects (Module 2)	11
NIS Essentials for Investigators	11
The Principles of the General Data Protection Regulation (GDPR)	12
GCP for Clinical laboratories – online training in GCLP	12
Learn & Refresh UK Clinical Trial Regulations	12
The EU Clinical Trial Regulation	13
CTR for ALL – a high-level overview of the EU CTR	13
Managing and Reporting Serious Breaches of the EU CTR	14
Essential Guide to the EU CTR	14
Clinical Investigator Site Awareness: the EU CTR	14

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