The user-friendly Risk Assessment Form can be used to make a step-by-step assessment of a clinical research project's potential risks; it is in line with current GCP requirements.
This form helps you to identify potential quality risks of your clinical research project, evaluate these risks, and develop strategies to overcome them. As risks differ widely with different trials, the form’s instructions provide many examples for additional guidance. This form covers risks at both the system level and the clinical trial level.
This form is suitable for both clinical trials initiated in an academic setting and for project leaders running research projects according to the Human Research Ordinance (HRO). Part A applies to the system level and can be reused for different research projects running at the same site.
This form was developed by the SCTO’s Auditing Platform and first published in December 2019.
According to the Good Clinical Practice Guideline from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), referred to as ICH GCP E6(R2), it is the sponsor’s responsibility to ensure that an adequate QMS is in place to manage a clinical trial and address potential risks. Using this form helps you bring your risk assessment in line with the current requirements of ICH GCP E6(R2).
According to the Declaration of Helsinki and data privacy guidelines, it is the project leader’s responsibility to ensure that an adequate QMS is in place that can be used to oversee the project and address potential risks to the research project.
The complementary user instructions provide many practical examples and contain a step-by-step guide on how to complete the form.
This form is licensed under CC BY-NC 4.0. Its content can be shared and adapted as long as you follow the terms of the license. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc/4.0/.
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