Program Overview

AMG/GCP-Refresherkurs Blended Learning

This course consolidates and refreshes the fundamental knowledge for members of the examination team according to AMG and EU Regulation 536/2014 in a compact form.

Kursinformationen

The course aims to provide examiners, study assistants, and all other employees involved in clinical trials with the opportunity to refresh and deepen their knowledge. Participants will also gain an overview of the relevant innovations in this field. Such training certificates are required by ethics committees, in accordance with the curriculum of the Federal Medical Association.

Zielgruppe

The course is aimed at all parties involved and interested in clinical trials.

Abschluss

A written learning control is carried out via a multiple-choice exam. Upon successful completion, a certificate is issued.

Zeitrahmen

The course takes place via blended learning, consisting of two parts:

• Teil 1: On-demand modules with 3 units of theoretical instruction
• Teil 2: A virtual presence seminar with 1 unit of instruction, including practical exercises and a final MC test

Zertifizierung

For medical participants, the corresponding further training points are applied for at the Berlin Medical Association.

Bildungszeit

The course is recognized as professional further education by the Senate Department for Integration, Labor, and Social Affairs Berlin.

Evaluierung

The courses are evaluated by the participants and assessed by the training management.

Teilnahmegeb³hr

The participation fee for the course is 400 (including course materials and examination fees). Employees of Charitķ and public institutions receive a discount:

• Charitķ employees: 200
• Public institutions: 250

Kursinhalte

The course covers the following topics:

• Rechtliche und Ethische Grundlagen: Declaration of Helsinki, ICH-GCP (R3), AMG, 4. AMG─ndG, EU Regulation 536/2014, and the Professional Code for Physicians
• Planung und Vorbereitung: Responsibilities of the principal investigator, interfaces, resource checking, task delegation
• Durchf³hrung: Patient recruitment, patient information and consent, treatment according to the study plan, documentation
• Arzneimittelsicherheit: AE/SAE/SUSAR
• ▄berwachung: Monitoring