Human Research Beyond Clinical Trials: Conducting HRO Projects
Short Course

This online course covers regulatory requirements and practical aspects of conducting human research projects that are not considered a clinical trial. Actually, these types of projects make up the majority of 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).

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

People working in clinical research (investigators, sponsor-investigators, study nurses, study coordinators, clinical research associates, study physicians, assistant physicians, etc.) who are planning a human research project that might fall under the Human Research Ordinance (HRO)

  • Dr. Verena Golz

Verena Golz, PhD
Training and Education Departement of Clinical Research (DKF), University of Basel
c/o University Hospital Basel
Spitalstrasse 8/12
CH-4031 Basel

verena.Golz@usb.ch
Phone +41 61 328 51 47
Training and Education Department of Clinical Research

Available Mon, Wed, Thu

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 reduction will be applied when registering for the program. 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.

Medical Faculty of the University of Basel

Course language: English

Training certificates will be issued electronically.

Location

Zentrum für Lehre und Forschung Hebelstrasse 20, 4056 Basel Kleiner Hörsaal


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