OPEN CTU

Receive expert guidance and support from OPEN CTU – your dedicated partner for both investigator-initiated and industry-initiated trials

OPEN CTU offers comprehensive administrative and scientific services to researchers and departments at Odense University Hospital (OUH) in the planning and execution of randomised clinical trials. We are committed to supporting you at every stage of your project - from idea to implementation.

The type of support available depends on whether the trial is investigator-initiated or industry-initiated. However, in general, the support each trial receives from OPEN CTU is tailored to the individual needs of the investigator. There is no fixed plan, as we aim to provide the most suitable support for each unique project. Individual contracts are created between the investigator and OPEN CTU.

Further details are available below.

When you have a project idea or a draft protocol, reach out to OPEN CTU to ensure you get off to the best possible start.

You can contact us through our online OPEN application form, which also includes the CTU application form.

Once we receive your application, we will schedule a meeting with you. During this meeting, relevant staff from OPEN and Centre for Evidence-Based Medicine Odense (CEBMO) will provide expert advice and discuss how OPEN CTU can best assist you.

Before Starting the Trial

At the meeting, we will have a preliminary discussion about your project idea or draft protocol, focusing on key areas such as:

Feasibility and risk assessment
Scientific methods, strengths, and randomisation
Required legal approvals and agreements
How OPEN CTU can support your project

Depending on your needs, OPEN CTU can provide various types of support. For example, we can assist with:

Ongoing risk assessment throughout the trial
Protocol writing or assessment
Preparing participant information and consent forms
Preparing legal reviews and administrative documents
Managing cooperation agreements and contracts
Budgeting

These tasks are carried out in close collaboration with the investigator, who provides the necessary clinical expertise.

Note that tasks performed by OPEN CTU during the preparation stage are typically funded by OUH and are free for the investigator.

During the Execution of the Trial

Once the investigator secures funding for the trial, the project will typically receive an OP number, granting access to OPEN’s basic facilities and services (e.g., REDCap for randomisation and eCRF).

In addition to these basic facilities, the trial can continue to make use of OPEN CTU’s support.

During the trial execution stage, OPEN CTU can assist with:

Project management via a trial manager
Monitoring trial progress and quality
Interim analysis
Reviewing protocol amendments

Funding for these tasks will be coordinated with the investigator. Depending on the required tasks, full or partial invoicing may apply during this stage.

At the End of the Trial

In the final stage of the trial, OPEN CTU can help with reporting and closing the trial. This may include:

Project closure via a trial manager
Statistical analysis
Assisting with the presentation of results according to the protocol
Submission of reports to the authorities

Funding for these tasks will be coordinated with the investigator, and invoicing will be arranged based on the specific tasks required.

Contact OPEN CTU when you receive an inquiry from the industry, and we will support you during the preliminary negotiations.

You can contact us through our online OPEN application form, which also includes the CTU application form

Before Taking the Trial to OUH

At the meeting, we will have a preliminary discussion, focusing on key areas such as:

Feasibility and risk assessment
Scientific methods, strengths, and randomisation
Required legal approvals and agreements
How OPEN CTU can support your project

If the department decides to move forward with negotiations with the company, OPEN CTU can assist with:

Contract review
Budget review

These tasks are carried out in close collaboration with the investigator, who provides the necessary clinical expertise and knowledge of the specific conditions within the department.

Tasks performed by OPEN CTU prior to finalising an industrial trial agreement will be budgeted as part of the start-up fee for the industry trial. If OUH does not reach an agreement, the support provided by OPEN CTU will be free.

During the Execution of the Trial

Once the trial is initiated, the department will continue to receive assistance from OPEN CTU.

Support from OPEN CTU may include:

Monitoring the progress of the trial
Ensuring correct invoicing for industry services

The funding for tasks performed by OPEN CTU during the trial will be invoiced to the department. OPEN will work with the department to ensure that the trial budget includes these costs.

At the End of the Trial

In the final stage of the trial, OPEN CTU can assist with closing the trial. This may include:

Ensuring correct final invoicing for industry services
Assisting with the storage of investigator-specific documents, such as eCRF/trial data and TMF/trial documents

The funding for OPEN CTU’s final tasks will be invoiced to the department. OPEN will work with the department to ensure that the trial budget includes these costs.

Trial Nation

In 2012, the five Danish regions established Clinical Trial Office Denmark to help attract more clinical trials to Danish hospitals. In 2014, one of the initiatives supported by the Danish government and private industry was the creation of the national coordinator network, Trial Nation, which manages feasibility inquiries from the industry.

For general questions and inquiries related to industry-initiated research, the Pharma Coordinator is the main point of contact.

Any questions about Trial Nation can be sent to the Pharma Coordinator at: open.trialnation@rsyd.dk