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Central structures – Clinical studies

Clinical trials are research studies involving human participants, which are conducted in order to test new medicines or to evaluate innovative treatments or diagnostic procedures. Clinical trials are subject to strict legal requirements and are conducted in accordance with internationally accepted ethical and scientific standards. At every stage of the process, the rights, safety, and wellbeing of trial participants all remain of paramount importance.

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Every year, Charité hosts more than 800 clinical trials, covering a wide range of therapeutic indications. The large majority of these studies are initiated and conducted by Charité researchers. These ‘investigator-initiated trials’ (IIT) rely on third-party funding, which has to be secured from public funding bodies (BMBF, DFG, EU), foundations and industrial partners. Its outstanding research environment also makes Charité an attractive partner for pharmaceutical companies, medical devices manufacturers and biotechnology companies (contract research).

Clinical Study Center (CSC)

Comprising the Clinical Trial Office (CTO) and the Clinical Trial Unit (CTU), the CSC is a centralized service facility jointly operated by the Faculty and the BIH. Its primary aim is to support Charité research staff (IITs) during the planning, set-up and conduct of clinical trials (those that fall under the scope of the AMG (Medicinal Products Law), MPG (Act on Medical Devices) and other trials). The Center provides full administrative and organizational support in addition to providing treatment places, examination rooms and research laboratories (including trial staff). This essential support removes time-consuming distractions, enabling researchers to focus all of their time, energy, and expertise on their clinical and research work. The aim is to conduct high-quality studies which comply with national laws and meet internationally recognized standards (e.g. ICH-GCP) in order to safeguard the two primary aspects of Good Clinical Practice: the rights, safety and wellbeing of trial participants, and the quality of trial results.

Details of the services offered by the CTO (Process Management, Quality & Compliance, Data Services) and the CTU (Lab Management, trial staff, Physical Assessment Lab, Nutrition Lab, Cognition Lab, PROMIS and EEG) can be found on the CSC homepage. The page also provides information on our comprehensive training program, which is targeted at trial staff and offers training and qualifications which are relevant for clinical research.

Quality Assurance Unit – Clinical Trials

The ‘Quality Assurance Unit – Clinical Trials’ (Short: QA-Unit – Clinical Trials) is a Faculty unit which operates independently of researchers, research services and support structures. This ensures that the unit can fulfill the independent quality assurance and audit functions stipulated by ISO 19011 (Guidelines for Auditing Management Systems). The Unit supports the Executive Board in coordinating and conducting quality assurance activities within the area of clinical trials.

The aim of quality assurance in clinical trials is to optimize and standardize processes in order to improve compliance, resource use and efficiency.

The core responsibility of the QA-Unit is to further develop, coordinate and implement measures which are aimed at quality assurance in clinical trials conducted at Charité. This particularly applies to investigator-initiated clinical trials for which Charité has accepted the role of Sponsor. The QA-Unit can delegate quality assurance activities to the Clinical Study Center (CSC).

Quality assurance vs quality control – what is the difference?

Quality Assurance

Quality Control

Carried out by an independent person who is not directly associated with the process being monitored.

Quality control is carried out by the person performing, guiding or monitoring a particular process.

Quality assurance is guided by processes and procedures which are entirely independent from those regulating trial conduct.

Quality control interferes directly with a specific process and thus impacts directly on its quality.

Example: independent monitoring of standards (e.g. audit).

Example: Checking documentation on site (four-eyes principle).