Research Fundamentals Training Course

Description

 

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 program consisting of four units that may be applied towards your yearly CPD portfolio.

Each unit includes a series of topics, supported by videos, recommended readings and external resources, summary tables, diagrams, and custom infographics. A comprehensive reference list of accessible peer-reviewed journal articles and reputable web resources is provided for further learning.

At the end of each unit, there is an assessment quiz, consisting of multiple choice and interactive questions. A certificate of completion is awarded upon completion of the 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, however, we recommend following the set order. Each unit, including readings and assessment quiz, is expected to take around two hours. The total course offers approximately 8 hours of learning.

Learning Objectives

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.

Pricing

We are currently offering our Research Fundamentals Training Course for AUD $230 (inc. GST).
This includes:

• Immediate course access
• Approximately 8 hours of learning
• Downloadable study guides for each unit
• Automatically generated certificate of completion
• Free access to our Good Clinical Practice (ICH GCP) Training Course.

Registration Instructions

To register for the course, add the course product to your cart, view your cart, and proceed to the checkout page. If you already have an account with us, please click on the returning customer link to login, enter your payment details, and place your order. If you are new to our website, you will be asked to enter an account username and create a password on the checkout page. Your account will be automatically created and activated after you have completed checkout.

Once you have placed your order, you will be able to login and access the course from your Student Account.

Please view our Frequently Asked Questions for further instructions.

Note on bulk purchasing and purchasing on behalf of others:

Please note, our Research Fundamentals Training Course cannot be purchased in bulk. This course must be purchased individually, per user.

When purchasing a course, you will be asked to create an account (or login if you have already registered) on the checkout page. The course purchased will be tied to this account. If you are looking to purchase courses for multiple users, please complete checkout separately for each user, creating a new account for each user during checkout.

If purchasing a course on behalf of someone else, when filling out the Billing details section, please enter the name and email address of the person who will be completing the course as this is the name that will appear on the course certificate of completion. Users can edit their first and last name later if needed via the My Account page.

Terms & Conditions

Use of any Genesis Research Services Course is subject to the Online Education Terms and Conditions, which set out our Refund Policy, Cancellation / Variation details, Disclaimers and more. Please read these terms and conditions carefully prior to purchasing a course.