Online Courses

About Course

The CRA plays an important role in clinical research especially in monitoring the processes of clinical trials. This course provides practical training related to CRA job function and covers all the activities to promote successful monitoring studies for investigational products whether drug, biologic, and device trials. The course also describes the basics of project management adapted to clinical trials and emphasizes on an overview of pharmacovigilance through a good understanding of the current principles and guidelines. Upon course completion, participants will be provided training CPD certificates.

Course describes the drug development process, the importance of Good Clinical Practice (GCP), and the roles and responsibilities of the research team
Describes a CRA management philosophy based on competencies, performance objectives and metrics based on effective communication skills
Course defines the IRB/IEC regulations and describe the elements of a protocol and amendments
Course outline required elements of the informed consent
Describes the processes of clinical trial management
Describes methods for managing clinical research projects more effectively
Defines the impact of quality assurance and audits in clinical research

Course Content

Introduction Video

Introduction / Clinical Research Associate online training course

03:15

Module 1: Drug Development Process & GCP guideline

History of Pharmacology

16:16
Drug development and Clinical Pharmacology

11:03
General Considerations for clinical trials

01:05:21
Design and types of clinical trials

24:25
Overview of The Drug Development Process

31:06
GCP Wheel

01:14:26
Ethics Committees

14:13
Sponsor’s Responsibilities

17:01
Principle Investigator’s Responsibilities

10:45
The European Union Clinical Trial Directive

14:29
Clinical Trial Regulation EU No 536/2014

14:15
Final Guidance on Statement of investigator – form FDA 1572

14:40

Module 2: Principles of Clinical Research Associate

Module 3: Study Documentation

Module 4: Clinical Trial Management

Monitoring and Source documents

16:23
Feasibility Process and Site Evaluation Visits

37:42
Site Evaluation Visit

20:40
Site Evaluation Visit Report

23:54
Investigators Meeting and CRA Training

14:47
Clinical study Initiation and Monitoring

57:34
Close Out of the clinical trial

31:44
Fraud Misconduct/Audit and Inspection

57:32
Drug Accountability

08:10
The Growing Demand for Referral Networks and Site Booster Visits – Drivers, Challenges and Solutions

41:20

Practice Quiz

Module 5: Project management

Module 6: Biostatistics

Module 7: Data Management

Course Summary

Final Exam

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About Course

What Will You Learn?

Course Content

Introduction Video

Introduction / Clinical Research Associate online training course

Module 1: Drug Development Process & GCP guideline

History of Pharmacology

Drug development and Clinical Pharmacology

General Considerations for clinical trials

Design and types of clinical trials

Overview of The Drug Development Process

GCP Wheel

Ethics Committees

Sponsor’s Responsibilities

Principle Investigator’s Responsibilities

The European Union Clinical Trial Directive

Clinical Trial Regulation EU No 536/2014

Final Guidance on Statement of investigator – form FDA 1572

Module 2: Principles of Clinical Research Associate

The role of Clinical Research Associate

Soft Skills 1 – Communication skills

Soft Skills 2 – Time management

Module 3: Study Documentation

Informed Consent Form

Protocol

Module 4: Clinical Trial Management

Monitoring and Source documents

Feasibility Process and Site Evaluation Visits

Site Evaluation Visit

Site Evaluation Visit Report

Investigators Meeting and CRA Training

Clinical study Initiation and Monitoring

Close Out of the clinical trial

Fraud Misconduct/Audit and Inspection

Drug Accountability

The Growing Demand for Referral Networks and Site Booster Visits – Drivers, Challenges and Solutions

Practice Quiz

Exercises – Practice Questions – Quiz

Module 5: Project management

Project Team

Project Management 1 – Role and expectations

Project Management 2 – Monitoring guidelines

Module 6: Biostatistics

Medical Statistics 1

Medical Statistics 2

Medical Statistics 3

Module 7: Data Management

Green Light Package: Documentation for Investigational Drug Release

Source document verification

Essential documents

Trial Master File

Pharmacovigilance in Clinical Trials – Concept and Definitions

Serious Adverse Events (SAE) Reporting

Safety Reporting

Course Summary

Summary

Final Exam

Final test

Feedback form

Feedback form

Student Ratings & Reviews