Course title :  Good Clinical Practice - ICH Guidelines E6 R2  

Explore Good Clinical Practice (GCP) through ICH Guidelines E6 R2. Gain a deep understanding of essential principles, ensuring ethical and high-quality clinical research.

Description

Dive into the world of ethical and high-quality clinical research with our "Good Clinical Practice - ICH Guidelines E6 R2" course. Compliant with the International Council for Harmonisation (ICH) guidelines, this course offers a comprehensive exploration of GCP principles and regulatory standards. Whether you're a clinical researcher, sponsor, or investigator, you'll learn how to conduct trials with integrity, ensuring the safety and well-being of human subjects. Prepare to excel in the clinical research field and contribute to the advancement of medical knowledge. Enroll today for a brighter career in healthcare and research.

Why Online ?

  • Cost effective - Typically UK diploma starts from GBP £3000 per annum, but with online study, you can enjoy saving more than 60% on your educational investment.
  • Practical Content - The coursework is immediately applicable to the careers, and you can earn long-term gains including increase in salary and promotions
  • Study anytime, anywhere - You don't have to attend a College campus, so you can study from anywhere in the world. The online delivery enables you to download the lecture notes, submit assignments wherever you are.
  • Assessments - Assessment is via assignment submission

Who is this course for?

Career path

Career opportunities upon completing this course include Clinical Research Coordinator, Regulatory Affairs Specialist, Clinical Data Manager, or Clinical Project Manager in pharmaceutical companies, research institutions, or contract research organizations. Unlock your potential in the field of clinical research and drive the development of life-saving therapies.

Duration

The programme is available in 2 duration modes:

    • 6 Months
    • 9 Months
Entry Requirements

In order to apply you should have either:

    • OR;
Course Content
    1. Introduction to Good Clinical Practice (GCP)

      • Overview of GCP principles and importance in clinical research.
    2. Historical Perspective on ICH Guidelines

      • Explore the evolution of ICH guidelines and their impact on global clinical trials.
    3. Structure and Content of ICH E6 R2

      • In-depth examination of the structure and key content within ICH E6 R2 guidelines.
    4. Ethics and Patient Rights in Clinical Research

      • Focus on ethical considerations, informed consent, and safeguarding patient rights.
    5. Investigator's Responsibilities and Obligations

      • Understand the critical role and responsibilities of clinical trial investigators.
    6. Regulatory Requirements and Clinical Trial Authorization

      • Review the regulatory landscape and the process of authorizing clinical trials.
    7. Essential Documents and Record Keeping

      • Learn about the essential documents, data integrity, and proper record-keeping practices.
    8. Adverse Event Reporting and Safety Monitoring

      • Explore procedures for reporting adverse events and ensuring patient safety.
    9. Quality Control and Quality Assurance

      • Delve into quality control measures and the importance of quality assurance in clinical trials.
    10. Audits and Inspections in Clinical Trials

      • Gain insights into audits, inspections, and how to prepare for regulatory scrutiny.
    ear47mtete|0000C012B042|EducationTraining|tbl_courses|CourseDetails|CCEC30A1-F1F1-44AE-A114-08BBDAA8D501
Assessment

Assessment is via assignment submission

Fee Structure

The fee for the programme is as follows:

    • 6 Months - Accelerated mode @ GBP £1250
    • 9 Months - Standard mode @ GBP £950
Fee payment plans

The programme offers following fee payment plans:

    6 months programme● Payment option (a): GBP £416 x 3 monthly instalments
    ● Payment option (b): GBP £1187.50 x 1 instalment (We offer 5% bursary on total fee for students opting to pay in full)
    9 months programme● Payment option (c): GBP £190 x 5 monthly instalments
    ● Payment option (d): GBP £475 x 2 quarterly instalments
    ● Payment option (e): GBP £902.50 x 1 instalment (We offer 5% bursary on total fee for students opting to pay in full)
Accreditation

The programme is awarded by London School of International Business

How to apply?

Simply follow the 2 steps given below to apply:
1. Fill application form on-line at https://www.educationtraining.org.uk/enrolment-form/start.html
2. Pay application fee of GBP £10
(This can be paid online using credit or debit card)

Please visit our online application form to apply.