Integrative Clinical Study Center IKSZ

Their tasks include the care of the patients during the study period including blood sampling, study-specific examinations, appointment scheduling and monitoring as well as the very complex documentation of all study visits. The study nurse also takes care of the pre- and post-processing of all monitor visits.

In addition, the study office is the contact point for all study inquiries and conducts the correspondence with study centers, the legal department, the ethics committee, the accounting center, pharmaceutical companies and is responsible for travel expenses and accounting.

The medical staff selects patients for the study on the basis of the study plan, which is determined by the pharmaceutical company, and cares for them during the entire duration of the study. Since some medications are more likely to be prescribed by ophthalmologists in private practice due to their use, it makes sense to also recruit patients from ophthalmologists in private practice as they usually cannot cope with the effort of participating in studies. Therefore, the study can then be executed in the eye clinic. Networking with other eye clinics in Saarland and Luxembourg makes sense in order to acquire a larger patient clientele. The data collection and the dissemination of the results takes place according to the exact specifications of the respective pharmaceutical companies, exact knowledge of the procedures of the test plans and the documentation of the Case Report Form (CRF).

In addition, doctoral students are supervised in the study office with regard to data collection as well as biometric planning and clinical issues. Any conducted in the eye clinic must be approved by the respective ethics committee of the country. In order to enable study planning and for the submissio of applications to the ethics committee, the number of cases for each study is determined in advance. The biometric planning and evaluation of the individual studies is becoming increasingly complex for medical questions. The presentation and evaluation of the collected data including complex data structures as well as the interpretation of the results are therefore performed in cooperation with the doctoral students and supervising doctors with a trained statistician.