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.

Information about Electronic Records Management System

Investigator e-Site System Readiness Assessment

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 document below. 

Contact