Quality and Risk Management
In line with the Quality Policy of the Insel Gruppe our Quality and Risk Management is based on a quality culture that focuses on the welfare of our study participants and represents our commitment to achieving highest quality standards, successful clinical research and continuous improvement. For this, we have implemented a framework to meet the increasing quality requirements for clinical research, to manage quality in all phases of the research process and to ensure compliance with Good Clinical Practice (GCP), with the approved protocols/amendments and with the applicable legal provisions.
A systematic and risk based approach combined with pro-active issue management allows us to make sure that our resources are best targeted to address the most important issues and priorities, especially those associated with the wellbeing of our study participants and the quality and reliability of study data and results.
To support regulating the processes from research planning through conduct to completion, the Directorate of Teaching and Research provides research guidelines, document templates and Standard Operating procedures (SOPs) which are available to all Insel Gruppe AG employees on the Intranet: Studienkompass Insel Gruppe. The Studienkompass provides comprehensive practical support in the implementation of research projects in accordance with the Human Research Act (HRA), the Ordinance on Human Research (HRO), the Ordinances on Clinical Trials in Human Research (ClinO/ClinO-MD) and the ICH/ISO Good Clinical Practice Guidelines.
The Neurology Leadership is committed to an operating philosophy based upon professionalism and dedication, on openness in communication, integrity in cooperating with our partners, fairness and concern for employees and co-workers and responsibility and empathy towards our study participants.
Management of quality is an integral and critical part of our research operations and our Quality Policy requires that all our research activities consistently:
- maintain a high level of scientific excellence and ethical integrity
- meet the highest standards of professional performance
- uphold a sensitive perception and effective response to patient and study participant needs
- meet regulatory and legal requirements
- fulfil obligations and responsibilities in accordance with the Principles of Good Clinical Practice (GCP)
- produce high quality outputs and fulfil the expectations of our research partners
- focus on issues that matter, especially issues with risks to crucial areas such as study participant safety and data integrity and rightsize the efforts, resources and level of action accordingly
- follow a concept of continuous quality assessment and performance improvement
We define Quality Objectives as intermediate steps to support our efforts in achieving our Quality Policy and metrics are used to track the success in meeting the specified performance goals.
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
We use Risk Management procedures as early as possible during research planning to identify critical data and processes, as well as to assess any risks to participant safety and data integrity. This early Risk Management activity allows us to prioritize resources where it really matters, focus them on the critical elements of the clinical study from the onset, and ensure that any risk mitigation actions are included in the study protocol and/or functional plans (e.g. monitoring plan) before they are finalized or before beginning an externally sponsored study.
Risk assessment is the first step in developing a proactive approach to support Quality by Design principals. The study teams identify critical to quality factors, build a strategy to support what's important, take actions to de-risk the protocol, build robust processes, evaluate performance objectively and adjust strategy as needed.
Quality Review is conducted at least once a year by the Neurology Research Board in order to review the continuing suitability, adequacy and effectiveness of our Quality and Risk Management. This review includes:
- assessing achievements and weaknesses of our research quality management
- evaluating the effectiveness of our Quality Management System
- recognizing opportunities for improvement and the need for changes to the QMS, Quality Policy and Quality Objectives
Continuous Improvement based on the Plan-Do-Check-Act Cycle is an essential concept of our Quality Management approach starting with the definition of requirements in line with the Quality Policy, implementation of study conduct procedures and quality assessments by the Neurology study teams, generating outputs of the Quality Review followed by effective preventive and corrective actions.