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Good Documentation Practice & Data Integrity

A professionally developed, interactive and engaging online course essential for anyone working in Clinical Research.

Provided by Trainingonline4U Ltd

Summary

Price
£99 inc VAT
Or £33.00/mo. for 3 months...
Study method
Online
Course format What's this?
Reading material
Duration
2 hours · Self-paced
Access to content
90 days
Qualification
No formal qualification
Certificates
  • Certificate of completion - Free

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Overview

This professionally developed Good Documentation Practice (GDocP) and Data Integrity course explores data integrity and document requirements in detail and demonstrates how GDocP can be implemented into a number of roles.

Good Documentation Practice is mandatory to ensure that documentation (and ultimately products) meet industry standards and other legal responsibilities in the pharmaceutical sector.

Certificates

Certificate of completion

Digital certificate - Included

A certificate will be immediately downloadable upon completion.

Resources

  • GDocP & Data Integrity Leaflet - download

Description

Learning Objectives

  • To understand what GDocP is and why it is important
  • To understand the various types of essential documents
  • To explore which essential documents are required at which stage of the clinical trial process
  • To examine ICH GCP E6 R2 and its requirements in regard to essential documents and how to archive essential documents according to ICH GCP standards
  • To know about different types of documents
  • To understand different types of data
  • To understand the importance of data integrity and ALCOA+ and be able to implement these in your role
  • To understand the role of security and data protection in GDocP

Who is this course for?

This course is suitable for anyone working in clinical research.

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Provider

Trainingonline4U Ltd

Trainingonline4u are a team of dedicated professionals with a wealth of knowledge and experience. Our team has a vast array of expertise in several different areas. We have an extensive base of subject matter experts enabling us develop our e-learning projects for topics in Education, Clinical Research and Personal Development. We are experienced in developing  effective engaging e-Learning programs that are engaging and fully interactive. In addition, we have vast experience in developing training materials and course content to deliver face to face training. We are able to create bespoke training packages for our clients that give their workforce a fully immersive learning experience. 

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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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