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Building a body of evidence

Centre for Clinical Trials – ZKS-UW/H

Expertise in clinical trials

The Centre for Clinical Trials at Witten/Herdecke University (ZKS-UW/H) supports the university’s own institutes, clinics and departments in conducting clinical trials.

Thanks to close collaboration within the university, it serves as a central point of contact for methodological research and for training and further education in clinical research.

As a full member of the Consortium of Co-ordination Centres for Clinical Trials (KKS Network), it also serves as a key partner for clinical trials funded by ECRIN.

The ZKS-UW/H works closely with various partners and institutions, including:

Practical support for clinical research

Clinical trials form the basis for understanding the causes of diseases, diagnosing them and developing preventive or therapeutic measures. However, setting up a randomised controlled trial (RCT) is highly challenging from a clinical, methodological, ethical and organisational perspective. The Centre provides support in this regard by working in accordance with all applicable standards and assisting with the design, planning, organisation and conduct of clinical trials.

Depending on your needs, our services include consultancy, acting as sponsor, conducting trials, and monitoring and documentation.

We adhere to the ‘Guidelines on Good Clinical Practice’ (GCP), statutory requirements such as the German Medicines Act (AMG) and the Medical Devices Implementation Act (MPDG), as well as international regulations (such as EU Regulation 536/2014, EU Regulation 2017/745 (Medical Devices Regulation) and EU Regulation 2017/746) to ensure the highest quality standards.

Consultancy and planning for clinical trials

Taking on the responsibility of being a sponsor

Study and Project Management

Study Nurse duties

Teaching biometrics and statistics

Quality Management

Training and further education

Public Relations

Current research projects

  • Caesarean section without an indwelling catheter: To what extent do caesarean sections without an indwelling catheter reduce the rate of bladder infections (cystitis)? (Department of Gynaecology and Obstetrics, Perinatal Centre Hannover)
  • Tolerability of SARS-CoV-2 vaccines: How well are SARS-CoV-2 vaccines tolerated by hospital staff, and how does their health status develop six months after vaccination? (Chair of Anaesthesiology I, Cardiology, Helios Klinikum Hildesheim)
  • Titanium fusion implants for pelvic fractures: How effective is a titanium fusion implant in combination with special screws for pelvic fractures? (ZKS-UW/H and Centre for Orthopaedics and Trauma Surgery, Mainz)
  • VAC-STENT Register: How successful is the combination of a nitinol stent with negative-pressure wound therapy for treating leaks in the digestive tract? (Department of Visceral, Vascular and Transplant Surgery)
  • PATCH Study: How effective is tranexamic acid in treating coagulation disorders and bleeding in seriously injured patients in the emergency medical services? (ZKS-UW/H and Institute for Research in Surgical Medicine)
  • Meshes for hernia treatment: How do the efficacy and safety of a biological mesh differ from those of a synthetic mesh in the treatment of abdominal wall hernias? (Department of Visceral, Vascular and Transplant Surgery)
  • MitraPRO Study: How does the MitraScore influence 1-year mortality and prognosis following MitraClip implantation in patients with mitral valve regurgitation? (ZKS-UW/H and HELIOS Hospital Siegburg)
  • VAC Stent Study: How effective is the combination of a nitinol stent and negative-pressure wound therapy for treating leaks in the digestive tract? (Department of Visceral, Vascular and Transplant Surgery)
  • Pain assessment with eEgg: How accurately can pain be measured during spinal blocks using force measurement with eEgg? (Helios University Hospital Wuppertal, Pain Clinic and ZKS-UW/H)
Graphic of two essays, shown abstractly, on a green background

Publications

All publications by the Centre for Clinical Trials at UW/H are gradually being included in the university bibliography.

University Bibliography

Other research projects involving the ZKS

Learning about ethical and legal principles

Since 12 July 2025, a new joint guideline issued by the German Medical Association and the Working Group of Medical Ethics Committees in the Federal Republic of Germany has been in force, which serves to assess the qualifications of investigators, principal investigators, team leaders and medical members of trial teams.

The guideline also includes new curricula for the relevant continuing professional development programmes, which, in accordance with the guideline, apply equally to trials involving medicinal products, as well as medical devices and in vitro diagnostic devices. Separate courses for medicinal products and medical devices (including in vitro diagnostic devices [IVD]) are therefore NO LONGER required. Completing a course based on the new curricula qualifies participants for any type of clinical trial.

The following should be noted: If only a basic course or advanced course in accordance with one of the two applicable sets of regulations has been completed (previous investigator training courses in the field of medicinal products or medical devices), at least one refresher course based on the currently valid curricula is required in order to participate in the other type of clinical trial. For example: Basic course/advanced course under the German Medicines Act (AMG) + current refresher course = qualification to conduct clinical trials involving medicinal products, medical devices or IVDs.

With immediate effect, the ZKS-UW/H will only conduct training courses in accordance with the curricula valid from 11 July 2025. The new curricula also incorporate content from the ICH-E6 guideline (GCP) in its current revision R3 (in force since 23 July 2025). Separate refresher courses focusing exclusively on the updated ICH-E6 (GCP) may be useful in some cases, but are not mandatory under the requirements of the ethics committees and are not offered by us.

 

The following courses are offered at the ZKS-UW/H:

  • CTR/MDR/IVDR refresher course: 9 June 2026, from 1.00 pm to 5.00 pm, online via Zoom (flyer)
  • CTR/MDR/IVDR Foundation Course: 24 June & 30 March 2026, from 1.00 pm to 5.00 pm on both dates, online via Zoom (flyer)
  • CTR/MDR/IVDR Advanced Course: 14 July & 15 July 2026, from 1.00 pm to 5.00 pm on both days, online via Zoom (flyer)

 

Please register for the courses here. Do you have any questions? If so, please feel free to send us an email.

 

We charge the following participation fees:

  • Staff at Witten/Herdecke University (UW/H) and partner hospitals: free of charge
  • Faculty members (membership to be verified): €200 (basic or advanced course)/€125 (refresher course)
  • External participants: €400 (basic or advanced course)/€250 (refresher course)

 

Please note the following cancellation policy:

  • Cancellation up to 14 days before the course date is free of charge.
  • For cancellations made between 14 and 7 days before the course date, 50 per cent of the course fees will be charged.
  • After that, 100% of the course fees will be charged in the event of cancellation.
  • Cancellations must be made in writing to the email address gcp-kurs@uni-wh.de . The date of receipt of the cancellation is decisive for meeting the deadline. Otherwise, we will be unable to accept the cancellation and the full course fees will be charged. It is possible to nominate a replacement participant by arrangement. You will receive confirmation of the cancellation.

 

Contact

Do you have any questions about conducting your study? Would you like to apply for membership? Or would you like to apply for a sponsorship role through the UW/H? We’d be happy to help.

E-Mail

Management of the ZKS-UW/H

Team