Self-Paced, Self-Learning Courses

• ICH GCP Guidelines 
• Introduction to ICH E2A Guidelines (Expedited Reporting) 
• Introduction ICH E2F Guidelines (Development Safety Update Report - DSUR) 
• Clinical Study Report (CSR) Preparation (ICH E3)

Module 1 - Introduction to Clinical Research 

• Definitions and Significance of Clinical Research 
• Overview and Functions of BA-BE and Clinical Trials 
• Overview Of Drug Discovery 
• Types Of Clinical Trials, Clinical Trials Phases and Clinical Trial Designs 

Module 2 - Applicable Regulations and Law in Clinical Research 

• Historic Perspective and Evolution of Clinical Research Guidelines 
• ICH GCP Guidelines 
• Part C, Division 5 - Health Canada Food and Drug Regulations 
• Data Integrity and Good Documentation Practices (GDP) 
• 45 U.S. Code of Federal Regulations - Part 46 

Module 3 - Essential Documents 

• Essential Documents, Record keeping and Trial Master File (TMF) 
• Investigator’s Brochure Development, Usage and Importance 
• Protocol Development and Review Process 
• Inform Consent Document (Development, Usage and Importance) and Informed Consent Procedure 
• Case Report Forms (Design and Use) 

Module 4 - Regulatory Compliance and Ethics 

• Regulatory Submission and Approvals 
• Protection of Human Subjects (Informed Consent) (21 CFR Part 50) 
• Institutional Review Board (IRB) and Ethics Committee (21 CFR Part 56) 
• Investigational New Drug Application (21 CFR Part 312) 

Module 5 - Site selection, Initiation and management 

• Site Management Activities and Clinical Study Files/Trial Files 
• Investigator Selection and Site Qualification 
• Site Initiation Visit (SIV) and Site Activation 

Module 6 - Site Activities and Handling 

• Participant Recruitment and Retention 
• Investigational Product (IP)/Drug Management 
• Biological Sample Collection, Handling, processing, Storage and Documentation 
• Bio-Analytical Process Overview, Sample Management, Processing and Record Keeping 

Module 7 - Pharmacovigilance and Safety Reporting 

• Introduction of Pharmacovigilance 
• Introduction to ICH E2A Guidelines (Expedited Reporting) 
• Introduction ICH E2F Guidelines (Development Safety Update Report - DSUR) 

Module 8 - Study Close-out and Reporting 

• Study Close-out Procedure and Documentation 
• Clinical Study Report (CSR) Preparation (ICH E3) 
• 21 U.S. Code of Federal Regulations – Parts 11 
• 42 CFR Part 11 (Clinical Trials Registration and Results Information Submission) 
• TCSP2_Ethical Conduct for research involving humans

Module 1 - Introduction to Clinical Research 

• Definitions and Significance of Clinical Research 
• Overview and Functions of BA-BE and Clinical Trials 
• Overview Of Drug Discovery 
• Types Of Clinical Trials, Clinical Trials Phases and Clinical Trial Designs 

Module 2 - Applicable Regulations and Law in Clinical Research 

• Historic Perspective and Evolution of Clinical Research Guidelines 
• ICH GCP Guidelines 
• Part C, Division 5 - Health Canada Food and Drug Regulations 
• Data Integrity and Good Documentation Practices (GDP) 
• 45 U.S. Code of Federal Regulations - Part 46 

Module 3 - Essential Documents Essential Documents, 

• Record keeping and Trial Master File (TMF) 
• Investigator’s Brochure Development, Usage and Importance 
• Protocol Development and Review Process 
• Inform Consent Document (Development, Usage and Importance) and Informed Consent Procedure 
• Case Report Forms (Design and Use) 

Module 4 - Regulatory Compliance and Ethics 

• Regulatory Submission and Approvals 
• Protection of Human Subjects (Informed Consent) (21 CFR Part 50) 
• Institutional Review Board (IRB) and Ethics Committee (21 CFR Part 56) 
• Investigational New Drug Application (21 CFR Part 312) 

Module 5 - Site selection, Initiation and management 

• Site Management Activities and Clinical Study Files/Trial Files 
• Investigator Selection and Site Qualification 
• Site Initiation Visit (SIV) and Site Activation 

Module 6 - Site Activities and Handling 

• Participant Recruitment and Retention 
• Investigational Product (IP)/Drug Management 
• Biological Sample Collection, Handling, processing, Storage and Documentation 
• Bio-Analytical Process Overview, Sample Management, Processing and Record Keeping 

Module 7 - Data Collection, Verification, Monitoring and Data Management 

• Clinical Data Collection, Entry and Validation 
• Source Data Verification (SDV) 
• Monitoring Plan Development, Monitor’s Responsibilities and Clinical Site Monitoring (SMV) 
• Clinical Data Management (CDM) workflow 
• Statistical Analysis Plans (SAPs) and Fundamentals of Data Interpretation 

Module 8 - Types of Clinical Trial Monitoring, Safety Reporting and Quality Assurance 

• Risk-Based Monitoring (RBM) 
• Centralized Monitoring 
• Medical Monitoring, SAE/ADR Classification and Causality Assessment of SAE 
• Safety Reporting in Clinical Trials 
• Protocol compliance and Deviation Handling 
• Quality Management System (QMS) in Clinical Research 

Module 9 - Pharmacovigilance and Safety Reporting 

• Introduction of Pharmacovigilance 
• Introduction to ICH E2A Guidelines (Expedited Reporting) 
• Introduction ICH E2F Guidelines (Development Safety Update Report - DSUR) 

Module 10 - Study Close-out and Reporting 

• Study Close-out Procedure and Documentation
• Clinical Study Report (CSR) Preparation (ICH E3) 
• 21 U.S. Code of Federal Regulations – Parts 11 
• 42 CFR Part 11 (Clinical Trials Registration and Results Information Submission) 
• TCSP2_Ethical Conduct for research involving humans 

• ICH GCP Guidelines 
• Clinical Study Report (CSR) Preparation (ICH E3) 
• TCSP2_Ethical Conduct for research involving humans 
• Part C, Division 5 - Health Canada Food and Drug Regulations 
• Data Integrity and Good Documentation Practices (GDP) 

• ICH GCP Guidelines 
• Clinical Study Report (CSR) Preparation (ICH E3) 
• Data Integrity and Good Documentation Practices (GDP) 
• 21 U.S. Code of Federal Regulations – Parts 11 
• Protection of Human Subjects (Informed Consent) (21 CFR Part 50) 
• Institutional Review Board (IRB) and Ethics Committee (21 CFR Part 56) 
• Investigational New Drug Application (21 CFR Part 312) 
• 45 U.S. Code of Federal Regulations - Part 46