Brookwood Global Online Training Brochure 2023

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Contents2
Introduction3
Fundamentals of GCP4
The Clinical Trial Master File Essentials5
GCP for Sponsors6
Essential GCP for Sponsors6
GCP Refresher for Sponsors 1 – tallest buildings challenge6
GCP Refresher for Sponsors 2 – inspection challenge6
GCP for Investigators7
Essential GCP for Investigators7
GCP Refresher for Investigators 1 – tallest buildings challenge7
GCP Refresher for Investigators 2 – inspection challenge7
Are you ready for … a GCP inspection?8
Risk Management in Clinical Trials8
GCP for Clinical Data Management8
Pharmacovigilance (PV)9
Are you ready for … a PV inspection?9
PV for ALL9
Essential PV – Know PV9
PV for the Local Safety Contact and L-QPPV10
PV Refresher10
Essential Safety Reporting for the Investigator Site10
Non-interventional studies (NIS)11
Non-interventional Studies, General Principles (Module 1)11
NIS, Practical Aspects (Module 2)11
NIS Essentials for Investigators11
The Principles of the General Data Protection Regulation (GDPR)12
GCP for Clinical laboratories – online training in GCLP12
Learn & Refresh UK Clinical Trial Regulations12
The EU Clinical Trial Regulation13
CTR for ALL – a high-level overview of the EU CTR13
Managing and Reporting Serious Breaches of the EU CTR14
Essential Guide to the EU CTR14
Clinical Investigator Site Awareness: the EU CTR14

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