Risk-based monitoring

As is the case for all larger risky projects, clinical investigations in particular require ongoing risk-based quality assurance to ensure the rights, safety and well-being of all participants, the quality and reliability of the clinical data and the study. This central task is the responsibility of the sponsor and must be consistently thought through as early as the conception phase, implemented in a risk-adapted manner in the planning and preparation phase and operationalised in the implementation phase.

Risk-based monitoring is an integral part of ISO14155, the EU regulations (2017/745 and 2017/746), with national implementation (in Germany) through the MPDG. Based on the risk assessment, the type and scope of monitoring are determined before the start of the implementation phase.

As part of risk management, the reviews are carried out in relation to

the investigational medical device including clinical use

• the conduct of the clinical investigation including all individual components and their composition
• Compliance with the clinical investigation plan, including subsequent amendments, the legal requirements and those of the ethics committee
• Verification of source data

In particular, the procedures for the verification of source data depend on national and/or regional regulations and the applicable data protection regulations. When conducting digital clinical studies, the processes for verifying source data must be adapted accordingly and with the aid of technical functionalities.

The monitoring plan: Your guide to a safe and trustworthy clinical study

A carefully developed monitoring plan describes in detail how the trial will be monitored and controlled to minimise potential risks and ensure that everything runs smoothly. Firstly, the risks associated with the study are identified and appropriate risk control measures are defined. These include, for example, precautionary measures to protect participants or procedures to ensure data quality. The plan also specifies which processes and data must be closely monitored. It is important to carefully check and verify the source documents. Depending on the study, monitoring can be carried out on site, centrally or a combination of both. The plan clarifies the exact monitoring procedures and defines the responsibilities of all persons involved. It also describes the requirements for monitoring the study as well as methods for documenting and communicating the monitoring results. This ensures that everyone involved is always up to date. The plan contains clear methods and processes to ensure compliance.

Should persistent or exceptional violations nevertheless occur, it regulates the escalation procedure. Certain aspects of the study require special attention, as errors here could jeopardise the protection of participants or data integrity. The monitoring plan emphasises these critical points. Last but not least, the plan takes into account the special requirements with regard to data protection and the handling of personal data. With a comprehensive and detailed monitoring plan, you can be sure that your clinical study will be conducted according to the highest standards. It serves as a guide for a safe, trustworthy and successful trial project.

Monitors - the guardians of quality in clinical studies

Monitors are qualified specialists. They:

1. are qualified by training, experience and scientific or clinical knowledge,
2. have knowledge of the investigational medical device, relevant requirements, the study protocol (CIP) and the informed consent process.
3. Are trained in the sponsor's clinical quality management procedures and the specific monitoring procedures of the study, with this training documented in the sponsor's files.
4. are familiar with the systematic handling of risks.

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