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.

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.

Research Manager

For projects with biobank: Help to keep track of valid approvals, complete data and biobank at the end of the project, and to collaborate on biobank samples and methods ('research dating'). 

Good Budget Advice

There is an additional possibility of having a specific budget assessed by Gitte Jessing (CRU, Department of Oncology, AUH) and Jens Kanstrup Kjær (CRU, Department of Haematology, AUH)

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

Gitte Jessing (CRU, Department of Oncology, AUH)

Gitte Jessing - Head of the Clinical Research Unit (CRU), MBA.

Appointed as head of CRU in 2002. The unit initiates between 30 and 45 new trials annually.

Since 2006, the person responsible for budgets and accounts for CRU’s research funding, financial management and payment of salaries to foundation-salaried staff.

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.

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 the Regional Hospital West Jutland.