Research Fundamentals Training Course

Introduction

Genesis Research Services is dedicated to delivering accessible, contemporary training resources for clinical research professionals. Our goal is to support professional growth by providing tailored content that meets the needs of individuals across all backgrounds, roles, and experience levels in the research industry.

A successful career in clinical research requires a strong foundation in clinical trial concepts and an ongoing awareness of the industry’s ever-evolving landscape. To support this, we developed the Research Fundamentals Training Course to offer a comprehensive introduction to key aspects of clinical trials, breaking down complex concepts often encountered in the world of clinical research.

The course is ideal for those new to clinical research, looking to enter the industry, or seeking to strengthen their understanding of essential trial concepts. The material is relevant to all professionals involved in the design, conduct, management, analysis, and reporting of clinical trials.

This course was developed by a team of experienced clinical research professionals, including site managers, medical researchers, and clinical trial coordinators.

Course Overview

The Research Fundamentals Training Course is an online, self-paced learning course that consists of four (4) lessons (units) that may be used towards your yearly CPD portfolio.

Each unit is organised into a series of topics. Written content is accompanied by videos, links to recommended readings (journal articles and other resources), summary tables, and diagrams (including our own purpose-made infographics). A comprehensive reference list of accessible peer-reviewed journal articles and reputable web resources is also provided to further support your learning.

Each unit includes a reflection of learning activities in the form of an assessment quiz, consisting of various multiple choice and interactive questions.

A certificate of completion is issued upon the successful completion of the training course.

The units are designed to complement each other and expand your level of clinical trials knowledge. The units can be completed at your own pace, at a time that suits you. We highly recommend completing the units in the set order.

The expected duration of each unit, including the recommended readings and assessment quiz, is 2 hours.

Course Units

Unit 1: Introduction to Clinical Trials

This unit provides a comprehensive introduction to clinical research. It covers the research roadmap and the four phases of clinical trials and discusses the differences between pharmaceutical and medical device trials.
You will also learn about key aspects of research planning and trial development, including formulating a research question, hypotheses, and study objectives, outcome measures and endpoints, as well as protocol development and site selection. You will gain insights into participant recruitment strategies, enrolment processes, and study visits.

Unit 2: Clinical Trial Regulation, Roles and Responsibilities

This unit offers an overview of the regulatory landscape that governs human research, including Australian regulatory requirements and ethical review of clinical trials.
This unit also outlines the roles and responsibilities of key stakeholders involved throughout the lifecycle of a clinical trial, including sponsors, contract research organisations, investigators, human research ethics committees, study coordinators, trial monitors, and other healthcare professionals.

Unit 3: Clinical Research Study Design

In this unit, you will learn about the fundamental elements of clinical research design, including randomisation, blinding, and controls. Common study designs, such as randomised controlled trials, crossover studies, and cohort studies, are discussed, including their unique purposes, strengths and weaknesses.
This unit also covers how to mitigate bias and confounding factors through appropriate study design. Levels of evidence are also introduced.

Unit 4: Understanding Clinical Trial Results

This unit introduces fundamental statistical concepts necessary to interpret clinical trial data. You will learn about descriptive statistics, and inferential statistics, and the importance of hypothesis testing and determining statistical significance. Statistical methods to account for bias and confounders are discussed.
This unit discusses the importance of correct interpretation and critical appraisal of trial results, assessing clinical relevance, and transparency in reporting trial outcomes.

Instructions

Please read the instructions by clicking on the tabs below. Following these instructions will ensure that your progress is updated correctly and that your certificate displays the correct information. If you are experiencing any issues with the course, please refer to the Frequently Asked Questions before contacting us.

Course Progression

Assessment Quizzes

Course Certificate