GxP online courses

ICH GCP E6 (R2) training for sponsors, investigators, regulators and others in 14 languages

GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors.

Everyone involved in the conduct of clinical research must be competent to perform their tasks, qualified by education, training and experience. All available training courses address the GCP aspects of this requirement and have been updated with ICH GCP Integrated Addendum E6 R2.

All our courses are accredited by the SOTE Continuing Education Center, thus all certificates released are accepted for regulatory submissions by Hungarian Competent Authority (Nemzeti Népegészségügyi és Gyógyszerészeti Központ - NNGYK) and the Central Ethics Committee (ETT-KFEB).

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GCP face to face (ILT) courses

We provide customized instructor-led (ILT) or virtual instructor-led training (VILT) tailored to our clients' needs in conjunction with Brookwood Global.

The venue of the face-to-face ILT is chosen by the client.

Online courses

Essential GCP for Investigators

Online training available in 14 languages: English, French, German, Italian, Polish, LatAm Spanish, Brazilian Portuguese, Chinese, Japanese, Russian, Turkish, Serbian, Czech and Hungarian.

Based on the investigator responsibilities laid down in Section 4 of the ICH GCP E6(R2) guidelines.

Users can choose between a narrated or read-only (no sound) track.

The training is divided into key sections, each with interactions.

Integral quizzes and an online multi choice test at the end of the training confirm knowledge.

Those who attain the 80% pass mark receive certification.

Test answers can be reviewed and the test retaken.

Takes approximately 2 hours.

Participation fee: 55.000 HUF + VAT

GCP Refresher for Investigators

An interactive quiz game to scale the highest buildings of the world – it adds fun and interest to GCP training.

Investigator-specific questions cover a wide range of GCP topics based on ICH E6(R2).

11 levels of slightly increasing difficulty – complete them all to pass.

5 questions at each level – must get 4 correct to proceed (80%).

Feedback given for incorrect answers, with
opportunity to review and repeat the level.

Compulsory ‘Did You Know?’ sections to
enhance learning.

Takes approximately 1 hour.

Participation fee: 45.000 HUF + VAT