Anforderung an Prüfärzte

Requirements for Courses on Research Ethics and GCP, Investigator Level
  • Introduction to Research Ethics
  • Good Clinical Practice
English
2.0
updated: 24. 11. 2016
Requirements for Courses on Research Ethics and GCP, Sponsor-Investigator Level

In addition to requirements for Investigator Level

English
2.0
updated: 06. 03. 2015
Requirements for GCP Refresher course

Learning objectives (LO) and list of content (LC): Investigator and Sponsor-Investigator Level

English
1.0
updated: 17. 04. 2019
Guidance for researchers regarding Research Ethics and GCP Training
English
3.0
updated: 09. 05. 2017

Auswahl empfohlener Literatur für Prüfärzte

  • Forschung mit Menschen. Ein Leitfaden für die Praxis 2., überarbeitete Auflage 2015. Herausgegeben von der Schweizerischen Akademie der Medizinischen Wissenschaften (SAMW). (link)
  • Ethical Framework for Responsible Data Processing in Personalized Health Research Version 2 (07.05.2018). ELSI Advisory Group, Swiss Personalized Health Network (SPHN). Ein Projekt der Schweizerischen Akademie der Medizinischen Wissenschaften (SAMW). (link)
  • Helsinki-Declaration (1964/2013) Ethical principles for medical research involving human subjects (web link)
  • Emanuel E et al., What makes clinical research ethical? JAMA 2000; 283:2701-2711
  • Temple R and Ellenberg SS, Placebo-Controlled Trials and Active-Control Trials in the Evaluation of New Treatments. Part 1: Ethical and Scientific Issues; Annuals of Internal Medicine 2000; 133:455-463 (link)
  • Rid A et al, Evaluating the risks of clinical research, JAMA 2010; 304(13):1472-1479 (web link)
  • Grady C, Enduring and emerging challenges of informed consent, NEJM 2015; 372: 855-862
  • Guideline for Good Clinical Practice ICH-GCP E6(R2) (web link)