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Clinical Trials Audit Preparation
Trainingonline4U Ltd

This course will ensure you are competent and confident in your role in an audit.

Summary

Price
£109 inc VAT
Or £36.33/mo. for 3 months...
Study method
Online
Duration
3 hours · Self-paced
Access to content
90 days
Qualification
No formal qualification
CPD
2 CPD hours / points
CPD What's this?
Certificates
  • Certificate of completion - Free
Assessment details
  • End of course exam (included in price)
2 students purchased this course

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Overview

This is a professionally developed, interactive and engaging online course suitable for anyone working within clinical trials who wishes to gain an in depth knowledge of audits and inspections. The course describes what investigational medicinal product sponsors, contract research organisations and clinical investigators can expect when they undergo inspection or audit, including the purpose of audits/inspections, benefits and limitations, the auditing/inspection cycle, check lists, data gathering, analysis and interpretation and reports.

Audits are very much part of clinical research and it is vital for individuals and companies to ensure they are audit ready at all times rather than wait until an audit is expected. The course helps to prepare all those working within clinical research to understand the audit process. It will ensure each individual is competent and confident in their role in an audit.

Certificates

Certificate of completion

Digital certificate - Included

Assessment details

End of course exam

Included in course price

The exam at the end of the course requires a score of 80% or more to pass. All answers are contained within the course; you can re-take the exam if you need to.

CPD

2 CPD hours / points
Accredited by The CPD Certification Service

Resources

  • Clinical Trials Audit Preparation Leaflet - download

Description

This course helps to prepare all those working within clinical research to understand the audit process. It will ensure each individual is competent and confident in their role in an audit. Audits are very much part of clinical research, and it is vital for individuals and companies to ensure they are audit ready at all times rather than wait until an audit is expected.

Learning Objectives

    • Understand what an audit/inspection is and the purpose of it within clinical research
    • Explore the various types of audits/inspections
    • Develop extensive knowledge of the audit process itself, from preparation to report stage
    • Learn what the expectations are of you during an audit, and how to successfully navigate the audit process

Who is this course for?

This course is suitable for professionals in roles such as:

  • Clinical Research Associates (CRAs)

  • Clinical Trial Managers and Study Coordinators

  • Quality Assurance Personnel

  • Regulatory Affairs Specialists

  • Investigators and Clinical Site Staff

  • Clinical Trial Assistants (CTAs)

Questions and answers

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Reviews

3.0
Course rating
40%
Service
100%
Content
40%
Value

Legal information

This course is advertised on Reed.co.uk by the Course Provider, whose terms and conditions apply. Purchases are made directly from the Course Provider, and as such, content and materials are supplied by the Course Provider directly. Reed is acting as agent and not reseller in relation to this course. Reed's only responsibility is to facilitate your payment for the course. It is your responsibility to review and agree to the Course Provider's terms and conditions and satisfy yourself as to the suitability of the course you intend to purchase. Reed will not have any responsibility for the content of the course and/or associated materials.

FAQs

Study method describes the format in which the course will be delivered. At Reed Courses, 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.

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 Courses, many of which can be completed online.

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.

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.
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