The planning and conduct of a clinical trial are highly complex, involving a wide range of requirements regarding trial design, regulations, authorisations, timelines and finances, all of which must be taken into account and coordinated. The KKS Oldenburg provides advice on trial planning and offers support with the preparation, conduct and completion of clinical trials. Its main areas of focus are confirmatory clinical trials and clinical trials involving medicinal products and/or medical devices, as well as advice on all aspects of clinical trials.

The free study counselling service includes:

• Review of regulatory requirements, feasibility assessment and recommendations for the implementation of trials
• Biometric consultancy in co-operation with the Biometrics Service Centre (UOL)
• Support with applications for third-party funding (BMFTR/DFG) and with cost calculations for clinical trials
• Provision of templates for the preparation of protocol and other trial-specific documents, as well as their review

To arrange a study counselling consultation, 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)

The project management team at KKS Oldenburg supports researchers in meeting the regulatory requirements for clinical trials, from study counselling right through to the completion of the trial.
Working alongside the principal investigator or scientific initiator, KKS supports the trial from concept through to implementation.

The project management team offers services to coordinate the various project stakeholders (study management, points of contact at the University of Oldenburg, external third parties, etc.) and can take on operational tasks during the conduct of the trial, for example:

• Study preparation: study counselling, support with funding applications and budget planning, drafting contracts, obtaining insurance quotes, assistance with preparing study documentation, assistance with applications to ethics committees and regulatory authorities, registration (WHO Register)
• Study implementation: ongoing support throughout the study, e.g. monitoring of duration, milestones, budget and regulatory requirements, assistance with amendments, organisation of safety boards, principal investigator/ study meetings, support with audits and inspections
• Degree: contributing to the final report, deregistration with ethics committees and regulatory 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