Requirements for investigators
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
Selection of recommended literature for investigators
- 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 (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)