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Essential Documents (Clinical Trials)

An enagaging and interactive online course in Essential Docments for clinical trials, includes a course certificate.

Trainingonline4U Ltd

Summary

Price
£29 inc VAT
Study method
Online
Course format What's this?
Reading material
Duration
1 hour · Self-paced
Access to content
90 days
Qualification
No formal qualification
Certificates
  • Certificate of completion - Free
3 students purchased this course

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Overview

This is a professionally developed, interactive and engaging online Essential Documents training course. It will provide an overview of essential documents, including which stage of the Clinical Trial process they will normally be generated. This course has been updated in 2022 to ensure all current Regulations are covered.

Resources

  • Essential Documents Course Leaflet - download

Description

Course Contents

  • Defining essential documents and their purpose
  • Types of essential documents
  • Essential documents before, during and after a Clinical Trial
  • ICH GCP E6 R2 and its requirements in regards to essential documents.
  • The purpose of the Trial Master File (TMF)
  • eTMF systems and their place in accurate storage and retrieval of essential documents
  • The roles and responsibilities of a monitor, sponsor and investigator regarding essential documents
  • How to archive essential documents according to ICH GCP standards

Who is this course for?

This course is suitable for anyone carrying out or involved in clinical research who needs to gain knowledge of essential documents and an understanding of their importance during each stage of a clinical trial.

Questions and answers

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Certificates

Certificate of completion

Digital certificate - Included

A certificate will be immediately downloadable upon completion.

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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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