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Good Clinical Practice - Basic Principles

2 Days

This interactive course with workshops is designed to bring you up-to-date with the current regulatory expectations and European GCP requirements. The course aims to provide an overview and practical advice on the application and implementation of international accepted principles for GCP and clinical research.

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Anyone involved in Clinical Research and Management

Time Schedule
08:30 - 09:00
Registration & coffee
09:00 - 17:00
Course (lunch included)
€ 1740

per participant    (excl. VAT)

✓ Exclusive learning approach

✓ Personal course documentation

Lunch, water, coffee & tea


✓ Course certificate after completion


Quastion Learning Center (Qplus consult BVBA)

Leuvensesteenweg 643 bus 7, 1930 Zaventem, Belgium

Your Trainer

Kristina Bindus


Introduction to ICH-GCP

  • Why ICH-GCP guidelines were established

  • Legislation

  • Clinical development program

Clinical Trial Protocol

  • What does it all contain?


Ethics Committee

  • Which responsibilities

  • Which requirements to follow


Sponsor and Investigator

  • Which responsibilities

  • How to choose

Patient Recruitment

  • Informed Consent: what's in a name?

  • How to recruit?

Conduct and Monitoring

  • Data handling: is it easy or not?

  • What needs to be monitored?

  • Who will monitor?

Safety Data

  • What's the difference between an Adverse Event and an Adverse Drug Reaction?

  • How to report safety data

Essential Documents

  • What, where and when?


  • Is it time to closure?

Result Analyses and Interpretation

  • How to obtain a Clinical Study Report

Communication of Trial Results

  • How to communicate on Clinical trial results

  • What about the publication?

Data Filing and Registration

  • How to file your clinical trial data and registration

Participants about this course:
Contact Quastion for more information about this Good Clinical Practice - Basic Principles training.
Other courses you might be interested in:

On demand

Good Clinical Practice - Advanced Principles

3 Days

Heading 6

+32 (0) 2 899 05 68

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Leuvensesteenweg 643 bus 7

1930 Zaventem


TAV: BE 0822 940 179

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a division of

Qplus consult BVBA