Dear Colleagues,
Welcome to the website of the Clinical Trials and Proficiency Testing Center at the Institute of Pathology, University Hospital Erlangen.
Tissue samples play an increasingly important role in research and quality assurance. They form the basis for numerous clinical trials, support the conduct of quality-related interlaboratory tests, and are also indispensable for the development and validation of modern, AI-supported analysis methods.
The responsible handling of human tissue is our top priority. The use of tissue samples always takes place in compliance with ethical, legal, and data protection requirements. Transparency, traceability, and the protection of patients’ interests are at the heart of everything we do.
On the following pages, we would like to provide you with a more detailed overview of our ethical approach to handling tissue samples and explain the two most common areas of application for tissue requests:
Key responsibilities
Tissue Samples for Research Purposes
When receiving requests for the provision of tissue samples for clinical trials or other research projects, we always take our patients’ interests into account. This includes, in particular, ensuring that any further diagnostic testing that may be required at a later date can be performed, as well as preserving the possibility of participating in future clinical trials.
Each request is therefore carefully reviewed in the context of the patient’s individual circumstances, and, if necessary, additional consent is sought from the patient for the release of their unique diagnostically relevant material. This is because the transfer of tissue samples for research purposes takes place exclusively on the basis of appropriate consent from our patients. Furthermore, as a clinical research institution, we consistently adhere to the principles of Good Clinical Practice (GCP) and comply with all applicable ethical, legal, and regulatory requirements. These include, among other things, the documentation of diagnostically relevant findings, statutory retention requirements, and compliance with data protection regulations. In addition, the provisions of the Clinical Trials Regulation (EU) No. 536/2014 and the applicable data protection regulations are taken into account.
Key documents:
Clinical Trials
The Department of Pathology is a key partner in the conduct of clinical trials across numerous medical specialties and provides support in the planning and implementation of scientific projects. Through our daily processing and long-term archiving of tissue samples, we have extensive capabilities to identify suitable material and to prepare and provide fresh and fixed tissue for study-specific research questions.
Our team is your expert point of contact for the provision of tissue during patient enrollment, as well as for other study-specific services.
In addition, we offer comprehensive consulting services for the design and conduct of tissue-based biomarker studies (Investigator-Initiated Trials, IITs). Thanks to our many years of experience, we support you in planning your study, conducting feasibility analyses, and evaluating and implementing translational and secondary study objectives. Together with you, we lay the groundwork for successful study implementation.
To ensure timely and optimal support, we ask that you please contact us via our central email address at the very beginning of any clinical trial or IIT involving tissue collection:
ph-studienzentrale(at)uk-erlangen.de
Please submit the following documents:
- Anfragebogen Klinische Studien
- Study Protocol
- Lab Manual / Pathology Manual
Once we receive the documents listed above, we will assess the feasibility of the project and prepare a detailed cost estimate.
We look forward to a successful partnership.
Proficiency Tests
Proficiency testing is an essential component of quality assurance and serves to annually assess the performance of laboratories. As such, participation in proficiency testing is a key factor in ensuring our commitment to providing diagnostic care at the highest level.
For many years, we have therefore been actively involved as a lead or panel institute in conducting national and international proficiency testing. Our range of services includes both immunohistochemical and molecular pathological procedures.
Our expertise spans the design and development of new proficiency testing programs, the selection and validation of suitable sample materials, and the provision of tissue sections and digital scans. In addition, we support the technical evaluation and interpretation of results, thereby contributing to the continuous improvement of diagnostic standards.
Through our active participation in external quality assurance, we promote the standardization of diagnostic procedures and support laboratories in the DACH region in achieving reliable and reproducible results for optimal patient care.
We are happy to answer any questions you may have regarding existing or planned proficiency tests, as well as opportunities for collaboration. Please contact us at:
Contact
ph-studienzentrale(at)uk-erlangen.de
09131 85-22874
Pathologisches Institut
Studienzentrale
Krankenhausstraße 8-10
91054 Erlangen
Head
Prof. Dr. med. Dr. rer. biol. hum. Markus Eckstein
Sr. Managing Consultant | Chair of Translational Immunopathology | Director of Diagnostic Lab
Phone: +49 9131 85-47792
Medical staff
Dr. med. Fabienne Lange
Sr. Physician, Director of Autopsy Services (Prosector's Office), Deputy Director of the CTC
E-mail: fabienne.lange(at)uk-erlangen.de
