Our Quality Management System shall:

• provide the framework to achieve the required standards of our Quality Policy
• be proactive, risk-based and flexible
• include quality planning, quality assurance, quality control and quality improvement
• recognise that research with human participants takes place in the context of clinical care
• cover each research project from its design, conduct, analysis and report to its archiving process
• account for the diversity in clinical research types, the inherent risks of each individual research project and the relevance of the data collected
• acknowledge that the individual project quality system is owned by the study team and is adapted to best meet the needs of the given clinical situation
• provide appropriate oversight of clinical research, while enabling clinical investigators’ medical judgment and respecting study participants’ rights, safety, welfare and autonomy
• save critical resources and time by streamlining, monitoring and continuously improving processes

The main elements of Our Quality Management System are:

• Quality Policy and Quality Objectives
• Quality Manual / Project or Research Team specific Quality Management Plans including Feasibility Assessment and Risk Management
• Standard Operating Procedures (SOPs) and associated
• Quality Controlled Documents (QCDs)
• Quality Records 

SOPs give detailed written instructions to be observed in order to ensure compliance with applicable regulations, standards and study protocols. The QCDs consist of document templates, checklists and guidelines that assist in following the SOPs and support ensuring and documenting required compliance.

SOPs and QCDs are provided by the Directorate of Teaching and Research and are made available in the Studienkompass Insel Gruppe. In addition to the documents in the Studienkompass, Neurology Quality Management and the individual Neurology Research Teams develop and implement specific SOPs and QCDs as and if required for the Neurology studies.

Further key elements of the QMS include:

• defined organisational and accountability charts, roles and responsibilities
• appropriate documented training of personnel to meet the defined competencies of their role, and familiarisation with GCP
• a risk-based approach used to determine the extent of risk mitigation activities, monitoring, auditing and system validation activities
• regular self-assessments, Quality Reviews and Continuous Improvement incorporating Corrective and Preventive Actions (CAPA)

The Research Board has appointed a Quality Responsible Person to:

• plan, coordinate and maintain the Quality Management System
• support the study conducting units in the implementation of their study quality management scheme
• provide associated quality relevant activities such as training, auditing, quality reviews and continuous improvement

The Research Board has established a Quality Board with members from all the Neurology research units and representatives from the various main roles and responsibilities in clinical research. The Quality Board represents a meeting platform as catalyst for new ideas, with open discussion and evaluation of inputs. It meets at regular intervals to exchange information and to identify, analyse and consider ways of resolving risks and quality issues in order to improve study quality, efficiency and performance. An effective Issue Management will advance identification, assessment, escalation and communication of significant issues to support an efficient Corrective and Preventive Actions (CAPA) process in line with the impact of the issue. A Knowledge Management framework shall improve quality, compliance and pro-active risk evaluation/mitigation through best practices and lessons learned. It shall enhance the ability to maintain and sustain the experience gained so that it can be shared and applied throughout the research teams.

Participants Quality Board

• Prof. Dr. med. Marcel Arnold, Chair Quality Board & Head of Research Board
• Susan Baumann MSc, Quality Responsible Person (Contact e-Mail)
• Dr. med. Maxime Baud, Investigator
• PD Dr. med. Robert Hoepner, Investigator
• Prof. Dr. med. Selma Aybek, Investigator & Member Research Board
• Anita Zenger, Study Coordinator
• Dr. phil. Aleksandra Eberhard-Moscicka, Investigator
• Céline Reinbold PhD, Study Coordinator
• PD Dr. med. Olivier Scheidegger, Investigator
• Christine Brülisauer, Study Nurse