Institute for Clinical Research (IFS), Dirk Simon

Short description of the institution and department

The Institute for Clinical Research (IFS gGmbH) is a 100% subsidiary owned by UMG-GOE. As a non-profit Site Management Organization, IFS provides services for Contract Research and for investigators of the University Medical Center in Investigator Initiated Trials (IITs) like EUTrigTreat.

Contribution to the project

The IFS will coordinates the trial administration and data collection, monitor the all sites for compliance with the clinical protocol, and ensure that the sponsor receives secure data from all sites. The IFS will implement overall study coordination tasks (templates for synopsis, protocols, and SOPs) and provide services to the coordinating investigator. Clinical trial management includes communication with different trial sites, data management, principal investigator, sponsor and competent authorities. Regulatory affairs are responsible for applications to Ethic Committees, submissions to competent authorities, contacting manufacturing organizations, study registration, amendments and contract of insurances. The contract management negotiation all contracts and sub-contracts (if relevant). Clinical Monitoring will be performed directly by IFS in Germany and by country-specific CROs according to trial specific SOPs. The clinical trial will be monitored according to ICH GCP guidelines, European and national laws. Data management will develop the electronic data entry systems (computer-based case report form) and does the statistical analysis.

Institute for Clinical Research

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Universitätsmedizin Göttingen (German only)

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Ethikkommission