Planning and conducting a clinical trial is very complex, with a wide range of requirements regarding trial design, regulations, authorisations, timelines and finances that need to be taken into account and coordinated. The KKS Oldenburg advises on the planning of studies and offers support in the preparation, implementation and completion of clinical trials. The focus is on confirmatory clinical trials and clinical trials with the use of medicinal products and/or medical devices as well as consultations on all aspects of clinical trials.

Free trial counselling includes

• Review of regulatory requirements, feasibility assessment and recommendations for study implementation
• Biometric counselling in co-operation with the Biometrics Service Centre (UOL)
• Support with applications for third-party funding (BMFTR/DFG) and cost calculations for clinical studies
• Provision of templates for drawing up study plans and other study-specific documents and their review review

For an appointment for study counselling, please contact the KKS:

The data management of the KKS Oldenburg supports science-initiated clinical trials of
University Medicine Oldenburg in GCP-compliant data collection, data control, preparation for
data analysis, publication and archiving. In order for the results of a clinical trial to be credible, the data must be collected reliably and in high quality.

Once data management has been established, scientists in highly regulated clinical trials (e.g. AMG, MPDG) should be supported with the following services:

• Creation of study-specific ICH GCP-compliant validated databases
• Support with item selection, participation in questionnaire design
• Configuration and validation of electronic questionnaires (eCRF) for data collection
• User administration and user support for the eCRF
• Control of data validity through programmed rules
• Query management / off-site data checks to ensure data quality
• Implementation of the database lock at the end of the study
• Interface to biometrics (evaluation, biometric final report)

KKS Oldenburg's project management team supports scientists in fulfilling the regulatory requirements for clinical studies, from study consultation to the degree.
Together with the medical study management or scientific initiator, the KKS accompanies the study from the idea to the practical implementation.

Project management offers services in the coordination of the various project participants (study management, interfaces within the University of Oldenburg, external third parties, etc.) and can take on operational tasks in the implementation of the study, for example

• Study preparation: study counselling, support with funding applications and budget planning, preparation of contracts, obtaining insurance quotes, assistance with the preparation of study documents, assistance with applications to ethics committees and authorities, registration (WHO register)
• Study implementation: continuous monitoring of the study, e.g. monitoring of duration, milestones, budget and regulatory requirements, budget and regulatory requirements, assistance with amendments, organisation of safety boards, investigator/investigator meetings, etc. study meetings, support with audits and inspections
• Degree: collaboration on final report, deregistration with ethics committees and authorities

The aim of quality management at KKS Oldenburg is to establish, maintain and continuously develop a quality management system. This will standardise processes in the context of clinical trials and thus promote high quality.

• To this end, KKS Oldenburg will set up an SOP system and provide members of University Medicine Oldenburg with templates and forms for clinical trials. University Medicine with templates and forms for clinical trials
• Quality management at the KKS reviews quality-relevant processes, regulations and procedures in accordance with international standards (e.g. ICH GCP) and legal requirements in clinical trials (e.g. German Medicinal Products Act (AMG), Medical Devices Implementation Act (MPDG) and European regulations)
• Internal quality management focuses on the processes within the KKS Oldenburg. The aim is to organise the work processes efficiently, to describe them in a comprehensible and transparent manner and and implementation of the specified internal standards

• The formal review of the sponsor takeover (by the University of Oldenburg), including a statement before the start of the study, is carried out by KKS Sponsor Quality Management carried out
• Sponsor QM assumes the sponsor's duties in quality assurance and, in the case of delegation, sponsor tasks in the conduct of clinical trials
• Quality assurance measures (such as internal audits) and establishment of processes for risk-based quality management and Sponsor oversight are also part of the sponsor QM tasks