Study cover for Good Clinical Practice
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Good Clinical Practice

Elevate Academy

1 days
Duration
135 EUR/full
135 EUR/full
Unknown
Tuition fee
Unknown
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Apply date
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Start date

About

The Good Clinical Practice program from Elevate Health is the international ethical and scientific quality standard on how clinical trials should be set up, conducted and reported. 

Visit the official programme website for more information

Overview

The Good Clinical Practice program from Elevate Health is the international ethical and scientific quality standard on how clinical trials should be set up, conducted and reported. Furthermore, it defines the responsibilities and tasks of people with key roles – such as investigators, sponsors and monitors – and identifies documents essential for clinical trials. This online medical course explains the context of the ICH-GCP Guideline and is comprehensively structured to follow the various phases of a clinical trial: preparation, execution and close-out. This makes the training suitable for all healthcare professionals that are involved in clinical research which includes participation of human subjects.

By the end of this training, you will understand the framework of international laws and regulations governing clinical trials, the applicability, purpose and key aspects of ICH-GCP. In addition, you will be able to identify the key parties in a clinical trial and understand their responsibilities, requirements and tasks throughout the different phases of a clinical trial.

Certificate & accreditation

Upon successful completion of this training, you will receive a recognized certificate from Elevate Health that is valid for 4 years. Furthermore, the training contents provide a great basis for the GCP-WMO registry exam by EMWO, for those that need to be registered in the Netherlands. This is further amplified by the strong focus on transferring knowledge into practice due to a continuous case.

This ICH-GCP E6 (R2) Investigator Site Training is fully accredited by TransCelerate BioPharma to enable mutual recognition of Good Clinical Practice training among trial sponsors. For medical specialists, additional accreditation (3,5 points) for general training clusters 1, 2 and 3 by KNMG (ID: 403508) is also in place.

Accreditation

This ICH-GCP E6 (R2) Investigator Site Training is fully accredited by TransCelerate BioPharma to enable mutual recognition of Good Clinical Practice training among trial sponsors. For medical specialists, additional accreditation (3,5 points) for general training clusters 1, 2 and 3 by KNMG (ID: 403508) is also in place.

Programme Structure

Topics include:

  • The first learning unit explains the motives behind the development of international laws and regulations, using historical facts as a basis. 
  • Three phases of a clinical trial through the perspective of three different roles: The second learning unit introduces the three phases of a clinical trial: the preparation phase, the execution phase and the close-out phase. In addition, we will also cover the three main players in a clinical trial: the investigator, the sponsor and the monitor.
  • Course closure: The third learning unit contains an extensive overview and summary of all the previous materials in the course. In addition, it provides you with practical information regarding the exam. Completion of the course exam is compulsory in order to receive the official certificate issued by Elevate. 

Key information

Duration

  • Part-time
    • 1 days

Start dates & application deadlines

You can apply for and start this programme anytime.

Language

English

Delivered

Online
  • Self-paced

Academic requirements

We are not aware of any academic requirements for this programme.

English requirements

We are not aware of any English requirements for this programme.

Other requirements

General requirements

To enroll in this course, you need:

  • An (academic) qualification in the medical field
  • Sufficient proficiency in English reading and writing

Tuition Fee

To alway see correct tuition fees
  • International

    135 EUR/full
    Tuition Fee
    Based on the tuition of 135 EUR for the full programme during 1 days.
  • National

    135 EUR/full
    Tuition Fee
    Based on the tuition of 135 EUR for the full programme during 1 days.

ICH-GCP Plus: € 155

Funding

Studyportals Tip: Students can search online for independent or external scholarships that can help fund their studies. Check the scholarships to see whether you are eligible to apply. Many scholarships are either merit-based or needs-based.

Fresh content

Updated in the last 6 months

Check the official programme website for potential updates.

Our partners

Good Clinical Practice
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Elevate Academy

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