Aiming to simplify your clinical trials?
We streamline processes.

Associate member

The SCTO is an independent organisation and is based on a joint initiative of the Swiss National Science Foundation and the Swiss Academy of Medical Sciences.

As of 2017, the SCTO is a research infrastructure of national importance funded by the State Secretariat of Education, Research and Innovation and the Swiss National Science Foundation.

Auditing

Coordination

Dr Anja Eskat and Dr Nicole Leisinger, UniversityHospital Zurich, CTU Zurich

SCTO Auditing Platform

tools

Align your risk assessment with Good Clinical Practice using these new tools

The Auditing Platform is pleased to share with you our Risk Assessment Form and its User Instructions, first released in December 2019.

These tools can facilitate improved, more informed decision-making and better use of available resources. We aim to provide you with guidance on risk assessment that supports the principles of Good Clinical Practice and to complement existing quality practices, requirements, and standards.

Here you can download and explore:

Questions or suggestions?
To connect with experienced auditors or to offer feedback on these resources, contact us at auditing@scto.notexisting@nodomain.comch.


Services

Professional and target-oriented consultation on general quality assurance questions

You‘re responsible for the quality of a study, but will it meet the required quality standards?

The SCTO Auditing Platform represents a pool of experienced quality managers and auditors. We offer auditing services in German, French, and English, providing professional and target-oriented consultation on general quality assurance questions. Let us connect you with experienced auditors in the national Clinical Trial Unit Network of the SCTO, to provide you with straightforward answers to your questions.

To request an audit and obtain competent answers to your questions, contact us at the SCTO Auditing Platform on auditing@scto.notexisting@nodomain.comch.


Auditing in brief

Independent, top-down methodical evaluation of trial conduct

Between brilliant research concepts and high-quality results, many meticulous steps are taken. Whereas monitoring is a quality control function, through which study conduct is routinely assessed at every step of a given trial, auditing serves a quality assurance function: the independent, top-down, methodical evaluation of trial conduct, and the underlying processes and systems.

Thanks to the scrutiny of qualified auditors, systems improve and trials become more efficient and streamlined. Auditors assess whether a system is lawful and serves its purpose. Furthermore, they check if trial activities are conducted following the sponsor’s Standard Operating Procedures, Good Clinical Practice, and the applicable regulatory requirements, and if data is recorded, analysed, and accurately reported according to the protocol. The rigour of auditing improves the quality and credibility of data produced, potentially helping it reach and benefit the public. 

Would you like to know how the experts in the Auditing Platform are channeling their efforts? For more information, consult the fact sheet below.