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The KKS Marburg can effectively support all processes of a clinical trial / study to support the quality of patient-oriented clinical research.
Our work is based on the guidelines of good clinical practice (GCP: Good Clinical Practice) as well as the applicable regulations (AMG, MPG, GCP regulation, etc.).

Our range of services allows you to leave the complete execution of your clinical trial / study to the competence of KKS.
Alternatively, tailor-made solutions can be adapted to your requirements.

  • Inhalt ausklappen Inhalt einklappen Sponsor functionSponsor function

    For clinical trials on humans initiated by scientists at the Philipps-Universität Marburg (IITs), the University of Marburg assumes the function of sponsor in the sense of §4 para. 24 German Medicines Act (AMG) or §3 para. 23 German Medical Devices Act (MPG).
    The sponsor function is delegated by the president of the university to the KKS Marburg, so that the KKS represents the university in the sponsor function in the external relationship.

  • Inhalt ausklappen Inhalt einklappen Study PlanningStudy Planning

    The KKS Marburg offers you support in the conception and preparation phase.

    Conceptually, we support you in evidence-based study planning and biometric planning of your project by:
    - Literature search
    - Biometric design, case number calculation and definition of endpoints
    - Review of legal requirements and quality assurance
    - Planning of logistical processes

    During the preparation we offer you support with:

    the preparation of study documents:protocol, patient consent form and patient information leaflet.
    - Development and finalization of the CRF
    - Investigator Site File (ISF) and Trial Master File (TMF).

    financial issues: planning of financing and support for the acquisition of third-party funds
    - Application for financial support

    compliance with regulatory requirements:
    - Submission of jointly prepared application documents to ethics committee and regulatory authorities.
    - Procurement of proband insurance, if required
    - Drafting contracts with participating cooperation partners

    project management to ensure overall coordination of multicenter clinical trials:
    - central contact person
    - Logistics and procurement of investigational medicinal products
    - Preparation of investigator meetings

  • Inhalt ausklappen Inhalt einklappen Study implementationStudy implementation

    We offer you support in all processes for conducting clinical trials and ensure compliance with these processes through an SOP system.
    A team of staff from different disciplines, composed according to the agreed responsibilities, is available for your project.
    Close cooperation between our biometricians, data managers, study coordinators, monitors and safety managers, actively supported in all matters by our IT department, ensures that your project runs optimally.
    The study coordinator (project manager) is available as a central contact person for you, who bundles the information and communicates it to the team.

    Study coordination (project management)
    - Coordination of multicenter studies
    - Coordination with participating institutions (pharmacy, laboratory, etc.) and committees (DSMC)
    - Organization of investigator meetings
    - Preparation and submission of amendments to the protocol
    - Maintenance of the Trial Master File

    - Contact person for the Trial Steering Committee
    - Preparation of the SAP (Statistical Analysis Plan)
    - Safety analyses for committees (DSMC: Data Safety Monitoring Committee)
    - Interim evaluations
    - Statistics for amendments to the trial plan

    IT support
    - Provision and maintenance of the online services used externally and internally
    - User administration and support for the EDC system (Electronic Data Capture)

    Data management
    - Programming and validation of study databases (e-CRF, web-based) with automatic plausibility checks
    - Preparation of data management plan and training material for data entry
    - Training of study personnel for e-CRF
    - Central randomization
    - Query management
    - Preparation of data for statistical analyses

    - Quality assurance at the trial center through on-site monitoring
    - Implementation of ICH-GCP guidelines at the site
    - Support in the maintenance of the Investigator Site File (ISF)

    Safety Management
    - Documentation and reporting of SAE messages
    - Coding of adverse events using MedDRA
    - Legally compliant reporting of suspected cases of unexpected serious adverse reactions (SUSAR reports)
    - Preparation of annual safety reports for studies according to the AMG

  • Inhalt ausklappen Inhalt einklappen Study degreeStudy degree

    Our team takes care of the tasks required for the successful completion of a study in the areas of statistical analysis / biometrics, data management and project management.

    - Closing of the study database after final plausibility and consistency checks
    - Statistical analysis according to SAS
    - Preparation of presentations and final reports
    - Joint publication of the results

  • Inhalt ausklappen Inhalt einklappen Contract management and financing planningContract management and financing planning

    Below you will find the documents required for "Conducting clinical trials or research projects with patient or subject participation".

    BEFORE accepting third-party funding and signing the contract/accepting the grant, the form including the attachment of the FB Medizin must be completed. The documents signed by all parties involved are sent directly to the Scientific Officer of the Department of Medicine.

    PD Dr. Bettina Westermann
    Phone: 06421-586 8665
    Fax: 06421-586 1548

    If you have any questions, please also contact the Science Officer directly.

    Anzeige von aus Mitteln Dritter geförderten Forschungsvorhaben gemäß § 29 Abs. 3 HHG
    ATTENTION: Compatible with Internet Explorer.
    Firefox and Chrome have problems with the display of the form.

    Anlage des FB Medizin zur Anzeige von aus Mitteln Dritter geförderten Forschungsvorhaben

    Mustervertragsklauseln für klinische Prüfungen als Orientierungshilfe

    If services from the clinic pharmacy are to be used, please contact the clinic pharmacy at the Marburg site immediately.
    immediately with the clinic pharmacy at the Marburg site (Phone: +496421/58-63350).

    To the KKS () documents to be submitted:

    1) The draft contract to be concluded with a third-party funder.
    (by e-mail as an unprotected! Word file).
    2) Detailed fee calculation of the third party funder (by e-mail as Word, Excel or pdf file).
    3) Study protocol/observation plan/project description (by e-mail).
    4) Ethics vote (as soon as it is available).
    Stand: 02/2021

  • Inhalt ausklappen Inhalt einklappen Support programsSupport programs

    Joint application for the acquisition of third-party funds from external funding programs

    Contact person: Carmen Schade-Brittinger ()

    The German Research Foundation (DFG) and the German Federal Ministry of Education and Research (BMBF) have different programs for the financial support of clinical studies for science-initiated projects. Together with you as scientific partners, we have already successfully submitted a large number of applications to these funding bodies. We support you in the preparation of the application, the drafting of the proposal and the planning of the study design as well as in the cost calculation of the overall project.

    The websites of the DFG and the BMBF provide current information on the funding of clinical trials and the funding priorities.

    A special feature of DFG funding is that draft proposals can be submitted at any time. The BMBF's calls for proposals are bound to a submission deadline.

    - DFG: Förderprogramm Klinische Studien
    - BMBF: Aktuelle Bekanntmachungen zu Forschungsförderung

    Information on other current funding programs of the EU and national and non-European organizations can be found in the research funding section of the Philipps-Universität Marburg web pages.