Contact

Secretary office:

Competence network "TDM KJP e.V."
Andrea Bäuerle
Clinic for child and youth psychiatry/ psychotherapy University of Ulm<
Steinhövelstr. 5
89075 Ulm


Tel.: (+49) 0731-500-61710
Email: Contact

 

Database

Within the internet data base (using pseudonymization) the following data are collected:

  • developmental and metabolism-related characteristics of patients
    (e.g. age, sex, substance use, nicotine use),
  • drug information
    (e.g. dosage, start of treatment, comedication, target symptoms, psychiatric diagnosis),
  • serum levels of medication ⇒ TDM laboratory,
  • wanted and unwanted effects of psychopharmacotherapy using standardized validated instruments.

Data Security

The comprehensive data security concept of the project is positively approved by the Bavarian data security board. It describes precisely all procedures concerning patients data (e.g. pseudonymisation) and the use of the data base. Every clinical investigator has to sign a contract before he obtains the rights and password necessary for the online access to the registry. Every participating hospital has only insight in the data of its own patients. For further evaluation a written application for data export is necessary and has to be proved by the data security advisory panel of the society. Quality of data is continuously confirmed by the data quality panel. Data are recorded with the medical database system SecuTrial®, a strictly internet-based system developed for collecting pseudonymised medical data. SecuTrial® is certified to meet all requirements according to GCP, AMG, EMEA and FDA (21 CFR Part 11). Furthermore the systems security concept (secure hosting, firewall system, daily database and logfile backups) possesses the TÜV-IT certificate "trusted site".