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Clinical Research Professionals

An Introductory course for those who are looking to go into a career of a Clinical Research Professional.


Trainingonline4U Ltd

Summary

Price
£499 inc VAT
Or £55.44/mo. for 9 months...
Study method
Online, self-paced
Duration
3 hours
Access to content
90 days
Qualification
No formal qualification
CPD
10 CPD hours / points
Additional info
  • Tutor is available to students
  • Certificate of completion available and is included in the price

1 student purchased this course

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Overview

Since 1996, when the ICH GCP E6 guidance was established, the role of the monitor has evolved, becoming increasingly accountable and complex. More sponsors have implemented risk-based monitoring approaches. E6 R2 discusses this risk-based approach in more detail and how this impacts the reporting and monitoring plan.

This interactive an engaging online course has been designed to provide an in depth understanding of the roles and responsibilities of a Clinical Research Professional. It is mainly aimed at the role of a CRA/monitor but it is also suitable for other roles that support a monitor such as a Clinical Trials Assistant, Project Managers or site staff wanting to gain a greater understanding of Clinical research. A. On completion of this training, participants will be able to apply their knowledge and skills to become an effective Clinical Research Professional. A certificate will be available once the assessment at the end of this course is completed with a pass rate of 80% or more.

CPD

10 CPD hours / points
Accredited by The CPD Certification Service

Course media

Resources

Description

Chapter 1 - What is Clinical Research?

  • Introduction to clinical research

  • Sponsor responsibilities

Chapter 2 - Ethics Committees / IRB

  • Ethics Committees/Institutional Review Boards

  • IEC and Competent Authorities (CA)

  • Review of IEC/CA responsibilities

Chapter 3 - Monitoring

  • Introduction to monitoring
  • Why Monitor a Trial?
  • Types of monitoring
  • Risk based monitoring

Chapter 4 - Informed Consent

  • Informed Consent-introduction

  • The 5 Steps of the Informed Consent Process

  • Informed Consent in detail

  • What should an ICF contain?

  • How to monitor the informed Consent process

Chapter 5 - Patient Safety

  • Patient safety- introduction

  • The reasons for and elements of safety reporting

  • What to do when AE, SAE or SUSAR occur

  • Monitoring and reporting-patient safety

  • Reporting of ADR and SUSAR

Chapter 6 - Essential Documents

  • Essential Documents

  • Documentation before, during and after a clinical trial

  • General rules for archiving Essential Documents

  • Monitor Responsibilities- Essential Documents

Chapter 7 - Investigation Product

  • Investigational Products

  • How to monitor IP

Chapter 8 - Source Document Verification

  • What is source documentation?

  • Verifying Subject data, the monitoring report and plan.

  • Types of data- knowledge check

  • ALCOA+

  • Late entries and corrections

  • Electronic Medical Records (EMR)

Chapter 9 - Questionable Data

  • Definitions

  • What should a monitor look for?

Chapter 10 - Queries

  • What are queries?

  • Dealing with queries

Chapter 11 - Audit and Inspection

  • What are audits and inspections?

  • Monitor conduct-Audits and Inspections

Chapter 12 - Knowledge Check

Who is this course for?

All people working within Clinical research looking to gain a greater understanding.

This course takes approx. 4 hrs to complete. This time will vary depending on the users previous knowledge and as the course contains lots of links to more information, it will also depend how many the user choose to access.

At the end of the course the user can download and print their own certificate as a record of their course completion.

Career path

It is mainly aimed at the role of a CRA/monitor but it is also suitable for other roles that support a monitor such as a Clinical Trials Assistant, Project Managers or site staff wanting to gain a greater understanding of Clinical research. A. On completion of this training, participants will be able to apply their knowledge and skills to become an effective Clinical Research Professional.

Questions and answers

Currently there are no Q&As for this course. Be the first to ask a question.

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FAQs

What does study method mean?

Study method describes the format in which the course will be delivered. At reed.co.uk courses are delivered in a number of ways, including online courses, where the course content can be accessed online remotely, and classroom courses, where courses are delivered in person at a classroom venue.

What are CPD hours/points?

CPD stands for Continuing Professional Development. If you work in certain professions or for certain companies, your employer may require you to complete a number of CPD hours or points, per year. You can find a range of CPD courses on reed.co.uk, many of which can be completed online.

What is a ‘regulated qualification’?

A regulated qualification is delivered by a learning institution which is regulated by a government body. In England, the government body which regulates courses is Ofqual. Ofqual regulated qualifications sit on the Regulated Qualifications Framework (RQF), which can help students understand how different qualifications in different fields compare to each other. The framework also helps students to understand what qualifications they need to progress towards a higher learning goal, such as a university degree or equivalent higher education award.

What is an ‘endorsed’ course?

An endorsed course is a skills based course which has been checked over and approved by an independent awarding body. Endorsed courses are not regulated so do not result in a qualification - however, the student can usually purchase a certificate showing the awarding body’s logo if they wish. Certain awarding bodies - such as Quality Licence Scheme and TQUK - have developed endorsement schemes as a way to help students select the best skills based courses for them.