Partner 6a - Universität Heidelberg
FemNAT-CD Team Uniklinikum Heidelberg
Institute presentation UKL-HD
In our FemNAT-CD project, we investigate the mechanisms of oxytocin on threat perception in highly aggressive young men and women in a placebo controlled pharmaco-challenge study. We therefore examine the effects of intranasally administered oxytocin on eye movements, reaction times and brain activation during emotional face perception.
Partner 6b - IMBI
FemNAT-CD Team IMBI
Head of Data Management
Data Management: WP5, WP7
M. Sc. Daniel Saure
Biometrician / WP5, WP7
Institute presentation IMBI
The department has a long and broad experience in planning, conducting and analyzing clinical trials. Prof. Dr. Meinhard Kieser has been the responsible biometrician for more than 100 clinical trials. He is editorial board member of the journals “Pharmaceutical Statistics”, “Journal of Biopharmaceutical Statistics”, “Drug Information Journal” and “Methods of Information in Medicine“. Christina Klose is the head of data management and has more than 25 years of experience in this field. Overall, she was responsible for data management tasks in more than 30 clinical trials.
There have been a number of previous cooperation projects in the field of psychotherapeutic treatment between the applicant partner in Frankfurt and the IMBI, where the institute was responsible for the biometrical tasks and data management. Examples for successful cooperation projects are the SOSTA-net trial (http://www.controlled-trials.com/ISRCTN94863788), a BMBF-funded systematic review of screening and diagnostic instruments for autism and related diseases (BMBF: KS8-336) and the BMBF-funded UBICA trial (BMBF: 01KR1207A), which is currently in the recruitment phase and is conducted in cooperation with the applicant partners in Aachen and Heidelberg.
Partner 6c - KKS
FemNAT-CD Team KKS
Institute presentation KKS
The Coordination Centre for Clinical Trials (KKS) Heidelberg, Germany, located at Medical Faculty Heidelberg, is initially being funded by the German Ministry of Education and Research (BMBF) and the Medical Faculty. More than 45 staff members support the whole spectrum of clinical research with a focus on conception, planning, conducting, and analysing innovative clinical studies according to current laws and international guidelines, e.g. Good Clinical Practice (ICH-GCP). The KKS Heidelberg has been working effectively since July 2000 and has been evaluated by different audits and expert assessments with successful outcome concerning quality and efficiency. KKS Heidelberg is already involved in innovative phase I to IV studies according to German Drug Law and projects following Medical Device Law inclusive in vitro diagnostics and innovative therapeutic agents.
All functions will be performed according to Standard Operating Procedures (SOPs) of KKS Heidelberg which are based on ICH-GCP guidelines, the implementation of GCP and current laws. In order to ensure the quality, the patient protection, compliance with ethical and legal stipulations as well as the application of adequate methods KKS Heidelberg provides e.g. the following services to clinical trials:
• Project Management and Regulatory Affairs: co-authorship for study protocols and essentials documents, application and authorization processes to ethics committees and competent authorities inclusive ongoing reporting procedures, logistic and documentation for study drugs and devices, supportive writing integrated study reports.
• Quality Assurance: Review of study protocols and study-related documents for consistency and to ensure that all clinical research activities are planned and performed according to ethical and legal principles as well as to ICH-GCP guidelines with control of data protection.
• Clinical Monitoring: Investigators’ training, individual site initiation visits, continuous on-site visits for source data verification, to ensure that rights and well-being of study participants are protected and investigators comply with the approved protocols and amendments.
• Pharmacovigilance: Providing professional staff (safety officer and safety data manager) and infrastructure to collect initial serious adverse event (SAE) reports, to keep an eye on data consistency and follow up reports, and to ensure in time reporting to ethic committees, investigators and competent authorities, as requested. Annual safety reports, inclusive development safety update reports (DSUR) will be issued in close cooperation with the coordinating investigator.
• Data Management and Biometrics: Definition of study design and clinical endpoints, sample size calculation, biometrical study report according to statistical analysis plan, data management procedures to ensure data collection according to study schedule; providing paper based (CRF) or internet based using validated Remote Data Entry (RDE) Tool; validation of data, query-processing and cleaning of data base before evaluation according to statistical analysis plan.