Human Research Beyond Clinical Trials: Conducting HRO Projects
This online course covers regulatory requirements and practical aspects of conducting human research projects that are not considered a clinical trial. Those types of projects make up most of the human research conducted in Switzerland. They are based on the collection or reuse of health-related personal data and/or biological material from participants and regulated in the so-called Human Research Ordinance (HRO).
The course content focusses on the specific requirements in Switzerland.
Main topics covered during this course will be: Swiss regulations and project categorisation, qualification and reporting requirements, authorisation procedure, project implementation from planning to publication including informed consent, registries and biobanks, institutions and resources providing support.
| Course language: | English |
| Duration: | 2-4 h, depending on previous knowledge and personal needs |
| Next Start: | online course, to be completed at every time and at own pace |
Online course that can be completed at your own pace at any time through self-study.
This course consists of five online training modules. At the end of each module, acquired competencies will be checked by an online quiz.
Welcome and introduction: Why is human research regulated, Clinical trials versus human research projects, Definitions and synonyms
Module 1: «Key aspects of HRO projects»: Types of HRO projects, Categorisation of HRO projects, Responsibilities and qualifications, Contracts and insurances, Informed consent, Handling of data and samples, Data registries and biobanks, Authorisation and reporting
Module 2A: «HRO projects based on the collection of biological samples and health-related data»: Informed consent, Handling of data and samples, Authorisation and reporting
Module 2B: «HRO projects involving further use of existing samples and data»: Informed consent, Handling of data and samples, Authorisation and reporting
Module 3: «Further aspects when conducting HRO projects»: Ensuring project quality, Setting up your project, Project completion
Duration: approx. 2-4h, depending on previous knowledge and personal needs.
This course is open for everyone interested in regulatory and practical aspects of human research apart from clinical trials.
It is especially appropriate for people working in clinical research (investigators, sponsor-investigators, study nurses, study coordinators, clinical research associates, study physicians, assistant physicians, etc.) who are planning or conducting a human research project that might fall under the Human Research Ordinance (HRO).
Fee CHF 200
Reduced course fee DKF research group members (for details see *)
*) The Department of Clinical Research (DKF) offers training grants for members of DKF research groups which result in the possibility to participate for free. The price reduction will be applied when registering for the course. Please note, that training grants can only be offered to DKF clinical research group members, who are working at the group leaders’ local study center.
Directors of Studies:
- Verena Golz, PhD
Mareike Gräter
Training and Education
Department Clinical Research (DKF), University of Basel
c/o University Hospital Basel
Spitalstrasse 8/12
CH-4031 Basel
mareike.graeter@clutterusb.ch
Tel. +41 61 556 59 76
Please register here.
Medical Faculty of the University of Basel