This course is designed for study nurses and will provide the needed expertise to conduct a clinical trial. Study nurses are responsible for organizational processes and they are the central link between physicians, patients, sponsors, clinical research organizations, and ethics committees.

The course is based on the curriculum of the KKS Network, a German association of academic coordinating centers for clinical studies, and uses the standards set out in ICH GCP E6 (R2) and EU Regulation 536/2014.

Next to the regulatory background the course also tackles and trains practical aspects necessary for the work as study nurse.

The course consists of 3 modules including, among others, the following topics:

First Module:

• General information and basics on clinical trials
• Regulatory aspects and ethical guidelines
• Principles of clinical trials
• Responsibilities
• Study protocol, patient information, and informed consent
• Adverse events

Second Module:

• Practical information for the trial site
• Study preparation and site organization
• Documentation and handling of study data
• Patient recruitment and visits
• Safety

Third Module:

• Quality control and completion of studies
• Monitoring and audits
• Archiving
• Essential documents
• Ethical evaluation

This course describes the differences between vaccine trials and pharmaceutical trials, identifies the challenges, and lets you understand the biological business. This course highlights the highly demanding activities and specific requirements of regulatory characteristics – the quality, safety, efficacy, and also clinical trial performance in the development of vaccines.

The first module of the course describes the characteristics of a vaccine trial in general and specific examples. This module draws attention to the particularities of a vaccine trial compared to a drug trial. Moreover, the possible issues and challenges from a vaccine trial are addressed. Key aspects are: types of participants, organisation, recruitment and the correct administration technique. Afterwards, the theory will be illustrated with examples of recently conducted vaccine trials and accompanied by a glance at the future of vaccine trials and devices in vaccine trials. The second module of this training will give an overview of the specific regulatory nature and potential impact of biological medicinal products and the various types of vaccines that may be developed. The third module gives the basic elements and illustrates the importance of the risk/benefit ratio of a vaccine from different points of view: the regulator and the manufacturer.

Programme highlights include:

The characteristics of a vaccine trial in general and with specific examples – bridging with the specific nature of vaccines
Discussion on the future of vaccine trials and devices in vaccine trials, including organizational aspects of vaccine trials
Illustrations with recently performed vaccine trials
The value of vaccines for the individual and for the society”: Overview of the specific nature and potential impact of biological medicinal products and the various types of vaccines that may be developed
Requirements for a pharmaceutical company to successfully achieve the development, licensing and marketing of vaccines
Risk/benefit ratio assessment
Further details following soon.

This training course is designed to familiarize personnel from clinical trial units and sites (project managers, clinical research assistants, etc. ) from the public and the private sector with the challenges of initiating and managing multinational trials. Many barriers can interfere and delay the initiation and the management of multinational clinical trials, the main objective of this course will be solution oriented to address the most common barriers in the European landscape. Among the obstacles, where vaccines are concerned, are the variety of national implementations of the European Regulation on clinical trials that govern the European clinical research as well as ethical considerations. The early identification of roles and responsibilities of all stakeholders, in both industry and academic research, as a key aspect to ensure good management of the clinical trial and effective harmonization among participating countries, will be covered. Another important consideration when conducting multinational clinical trials is the funding source and the budget preparation. Funding sources and key elements of planning a budget will be covered. The role of clinical trial data sharing and GDPR are also new difficulties that must be overcome when sharing sensitive data across borders. Primary considerations on how to plan clinical research that include data sharing plans, tools and services will be highlighted.

Further details following soon.