Research is driven by commitment to improve patient care and curiosity to explore new avenues. The OPEN Clinical Trial Unit has been established to improve the support for researchers conducting clinical trials.

Clinical research is a comprehensive undertaking that requires a thorough understanding of the relevant regulations.

The OPEN Clinical Trial Unit has been established to support researchers and facilitate more clinical trials at OUH. The goal is to ensure up-to-date knowledge on, among other things, project management, risk management, and relevant application processes within the organization, so that the researcher can be guided throughout the whole process.

Help will also be provided for the practical aspects of clinical trials, including translational considerations. It should be easy to engage experienced and competent research staff, such as project nurses and laboratory technicians, via flexible arrangements.

The research infrastructure needs to be made more visible to OUH researchers so they can initiate, implement, and disseminate their research in the best way possible. A single gateway to the research infrastructure would help OUH researchers to get an overview of the existing possibilities for research support. We also need research managers and research secretaries to continuously develop and update their skills.

We have great potential for undertaking clinical research using the existing data in established central registers and in regional and national clinical databases. We need to make sure that people can get help to access existing databases and to create new high-quality local databases.

STRATEGIC OBJECTIVES

We will ensure a visible and comprehensive infrastructure for researchers to undertake clinical trials and projects using research databases, registries and medical records.

PERFORMANCE GOALS

• By 2017: A single gateway to the research infrastructure will be established to give OUH researchers an overview of the existing possibilities for research support.
• By 2017: We will establish a framework to facilitate research using regional and national databases, registers and medical records.
• By 2018: We will establish a framework to guide and support researchers in establishing OUH-based datasets and to ensure the highest data quality.
• By 2019: OPEN will be extended with a Trial Unit to advise on planning and undertaking of clinical trials and to provide practical help.
• By 2020: All research secretaries will have completed one or more modules on SDU’s specialized programme for research secretaries.
• By 2020: All research managers will have completed a course on research management.

Status

OUH, SDU and the Region of South Denmark already offer researchers a wide variety of support functions.

The research network OPEN – Odense Patient data Explorative Network – was established in 2008 as part of OUH’s research strategy. It was expected that about 20 research projects could be enrolled each year. In 2015, OPEN enrolled project number 200 – with 70 new projects in 2015 alone. The details of all projects are available for researchers via OPEN’s website, which also provides information about protocols, data, and biological material.

OPEN was established as a research infrastructure to promote clinical research at OUH and KI. OPEN provides support for register research, randomization, and the establishment of biobanks and research databases.