News & further Information
Documentation of clinical trials in Healex ClinicalSite
Following the launch of the established study management system Healex ClinicalSite (CS) in February 2025 with a new role and rights concept, the Dean's Office now requests that all clinical research projects running in or since 2024 be entered into Helaex CS by the end of the first quarter of 2026 with at least the core data set (SOP CS01-A3 Kerndatensatz Studie und Prüfzentrum). Entering the core data set in Healex CS is mandatory for all clinical researchers at the faculty (SOP CS01 Kerndatensatz).
Healex CS continues to provide all departments with a management and reporting tool with additional options for research organization and documentation, such as integrated CV management or the portal function for integrated mapping of your current studies on websites.
If you do not yet have a CS account, please contact your department's user administration or the CTCC Support Team. The CTCC Support Team is also available to answer any further questions and provide training if required.
CTCC ClinicalSite Support is available at any time at ZKS-CS-Support(at)uk-koeln(dot)de and on Mondays and Wednesdays from 8:00 a.m. to 9:00 a.m. at 478-88135.
EU Clinical Trial Regulation 536/2014 (CTR)
EU Clinical Trial Regulation 536/2014 (CTR) on clinical trials on medicinal products for human use
The EU Regulation 536/2014 implemented a uniform, fully digital approval and reporting process for clinical trials with medicinal products throughout Europe.
The aim is to simplify and further harmonize the approval and reporting processes, but also to create greater transparency for the public.
Applications, reporting, and communication with the authorities and ethics committee(s) are now carried out electronically via the Clinical Trial Information System (CTIS), which is based at the European Medicines Agency (EMA).
Please contact the Sponsor Quality Assurance for Clinical Trials (Contakt) if you are planning a new clinical trial and/or ask for advice from the CTC Cologne (Project Consulting & Planning) as a first step. The CTC Cologne also offers relevant training (CTC Cologne Akademie). Further information and detailed training material can be found on the EMA website.
CTIS IDs
All institutions involved in a clinical trial (trial sites, sponsors, study centers, CTCs, CROs, etc.) are assigned a postal address (LOC ID) and an organization ID (Org ID) via the OMS (Organization Management Service).
The following organizational data is stored in the OMS for clinical studies conducted by the university or the hospital:
For IITs with sponsor University of Cologne (UoC):
ORG-100006227, LOC 1000011065,
Albertus-Magnus-Platz 1, 50923 Cologne
For trial sites at the University Hospital (UHC):
ORG-100012761 University Hospital Cologne AöR, LOC-100030763,
Kerpenerstr.62, 50937 Cologne
For trial sites and participating institutions that are not located on campus, other LOC IDs will be accepted. Please contact Sponsor QA for more information.
Please do not grant external sponsors permission to enter additional addresses or organizations in the OMS for the UHC or UoC.
Roles and user rights in the CTIS portal
Clinical trials conducted under the sponsorship of the UoC must be created in CTIS via Sponsor QA. The administration of roles and usage rights in the CTIS portal is also carried out via Sponsor QA using the template „CTIS_Anlage_Studie /_Antrag_CT_Admin Studie xy“. Please contact us if necessary.
GDPR and BDSG
The General Data Protection Regulation (GDPR; Regulation (EU) 2016/679) and the new Federal Data Protection Act (BDSG) came into force on May 25, 2018.
Further Information can be found at the following links on the websites of