BASIC
SIARA- AA001- INTRODUCTION TO GCP: The history of GCP • The purpose of GCP • The principles of GCP
BASIC
SIARA- AA002- INFORMED CONSENT IN CLINICAL TRIALS: The purpose of the Informed Consent • The content of he Informed Consent Form • The Informed Consent Process • How to obtain informed consent in accordance with ICH GCP
BASIC
SIARA- AA003- ESSENTIAL DOCUMENTS AND SOURCE DOCUMENTS: Requirements for Source Data and Source Documents. • The Essential Documents required for the conduct of a clinical trial. • The importance of good documentation practice.
BASIC
SIARA- AA004- SAFETY IN CLINICAL TRIALS: The definition of Adverse Events -AEs- and Serious Adverse Events -SAEs • Understand the reporting timelines for AEs and SAEs • Understand the Investigator Obligations in reporting AEs and SAEs
BASIC
SIARA- AA005- INVESTIGATIONAL PRODUCT -IP- MANAGEMENT: The importance of good Investigational Product management • Investigator Responsibilities for Investigational Product management
BASIC
SIARA- AA006- ROLES AND RESPONSIBILITIES OR IRBs -IECs IN CLINICAL RESEARCH: The roles and responsibilities of the IRB-IEC • The required composition and function of the IRB-IEC as per ICH GCP • The Investigators role in communication with the IRB-IEC