Clinical Trial Unit

Clinical Trial Unit – from idea to publication

In order to increase awareness of the academic support available to researchers, the Department of Clinical Medicine has brought together a number of support functions:

Clinicaltrials.gov

All clinical studies that require regulatory approval must be registered via Clinicaltrials.gov. 
You must have access permission to register information in the database.

Biochemical Research Unit (support)

The biochemical research unit is a core facility for biomedical research support. This includes the taking of blood samples, sample preparation, analyses of samples (ongoing or batch), and shipping of samples to other laboratories. We are ready to provide support for your research project from 07:00 to 23:00 all days of the week year-round. The service also includes counselling, information, and on-site inspection possibilities.

Contact project coordinators Lene Damm Christensen lenechst@rm.dk, Mette Mølby Nielsen memoni@rm.dk

Biostatistical Advisory Service (BIAS)

Statistical help and guidance in connection with clinical trials. Both initially and in connection with experimental design, power calculation, etc., and later in the process for the final data analysis.

Legal assistance with contracts and collaboration agreements

Contact Corporate Relations and Technology Transfer, AU (tto@au.dk) to ensure that contracts and collaboration agreements are drawn up in accordance with the applicable rules.

Please note that the Department of Clinical Medicine has a special workflow in relation to collaboration agreements. Read a description of workflows for the approval and signing of collaboration agreements here (PDF).

The Research Support Office

The Research Support Office provides support for researchers and managers in connection with externally funded projects. You can get help with applications, project administration and strategy.

REDCap

Advice and practical help in regard to methodological and technical aspects of data collection and data processing in clinical trials.

GCP Unit

Project management
Help with protocols, CRF, participant information, recruitment, documentation, monitoring, auditing and study reports.

Applications 
The Ethics Committee, The Danish Health and Medicines Authority and the Danish Data Protection Agency.

Visit the GCP Unit website.

Clinical Trial Budget Advice

(The main focus is commercial Clinical Trials)

Initial guidance can be found within the documents below. Please note that only the 'Recommended price list' should be used as documentation during budget negotiation.

There is an additional possibility of having a specific budget assessed by Gitte Jessing (HOD, Department of Public Health Programmes, Central Region of Denmark) and Jens Kanstrup Kjær (CRU Manager, Department of Haematology, AUH)

Contact Gitte and Jens by sending an email to budget@clin.au.dk

Gitte Jessing (HOD, Department of Public Health Programmes, Randers Regional Hospital)

Gitte Jessing - Head of Department, MPH, MBA, Department of Public Health Programmes, Randers Regional Hospital.

From 2002-2022 Head of CRU, Dept. of oncology at Aarhus University Hospital. Extensive experience in contract negotiations with both the pharmaceutical industry and cooperative groups prior to initiating and carrying out medical treatment trials in the oncology department. Attaches high priority to budget coverage in cooperative agreements with the pharmaceutical industry.

Since oct. 1st. 2022 HOD of Public Health Programmes, Denmark Central Region, located at Randers Regional Hospital. University Research Clinic for Cancer Screening is imbedded within the department, hence research funding is still a central issue .

Jens Kanstrup Kjær (CRU, Department of Haematology, AUH)

Jens Kanstrup Kjær - Project Manager, MSc in Health Science

Employed at the Department of Haematology, Clinical Research Unit in 2010 as a project biomedical laboratory scientist.

Since 2013, responsible for delegated management functions regarding financial management and contract management, including budget preparation and negotiation in clinical protocols at the Department of Haematology.

From 2014, also contract management for the Department of Medicine, Haematological Section at Regionshospital Gødstrup.