LVR-Klinikum Düsseldorf Hospital of the Heinrich-Heine University ...

LVR-KLINIKUM DÜsseLDORF – hOsPITaL OF The heINRIch-heINe UNIVeRsITY DÜsseLDORF
3.1.6 Outpatient Clinic
Director: B. Janssen (2004–2005 and from September 2009),
G. Winterer (from 2006 until August 2009), F. Schneider (until
2004)
The university’s Outpatient Clinic treats patients with all
types of psychiatric diagnoses. The Outpatient Clinic has
no legal coverage mandate, but is the university institution
for research and teaching. Within this context, in addition to
offering general psychiatric-psychotherapeutic consultations
it provides specialised care for the following mental
disorders in the form of specialised outpatient clinics:
s Chronic schizophrenic disorders
s Treatment-resistant depressive syndromes
s Anxiety and compulsive disorders
s Personality disorders
s Chronic treatment-resistant pain disorders
s Post-traumatic stress disorders
s Forensic outpatient clinic
s Behaviour therapy outpatient clinic
There is close cooperation with the wards of the LVR-
Klinikum. Thus, in particular those patients who – because
of the severity of their disorder – need to have therapist
continuity and be treated in the long term at one hospital can
receive treatment at the Outpatient Clinic. A total of 1,200-
1,600 patients are treated per year. In addition, the Outpatient
Clinic provides psychiatric and psychotherapeutic care for
the Düsseldorf University Hospital and the Sana-Hospital
Gerresheim. Patients of the Outpatient Clinic are included
in research projects by the various research laboratories
and groups described earlier in this report. In addition,
the Outpatient Clinic plays a role in the training of medical
and psychology students in the form of seminars, practice
sessions and internships.
3.1.7 Infrastructural facilities
3.1.7.1 Study Service Centre
Directors: J. Cordes; W. Wölwer
Scientific assistant: L. Kostorz, M. Jänner
Non-scientific assistant: K. Beseoglu, P. Pitters
The objective of the Study Service Centre, which is under the
direct control of the Medical Director, is to professionalise
clinical studies in the Department of Psychiatry and
Psychotherapy by pooling competences, making appropriate
resources available and optimising processes on a
116
Study Service Centre team
qualitatively high level. This approach should ensure that
innovative and investigator-initiated clinical studies are
carried out to the highest standards of quality and according
to GCP, the AMG (German drug law) and GCP-V as well as
other applicable laws and regulations.
The Study Service Centre, which was founded in 2008 and is
still in the process of becoming fully established, is seen as
a provider of services to all scientists within the department.
It supports studies by the pharmaceutical industry and
scientific studies with third party funding in the reporting
process to the LVR as well as in their realisation. In addition,
it provides advice for third party-funded scientific studies
in the planning phase and, after completion, also offers
support for data analyses. Collating all studies into the
Study Service Centre of the LVR-Klinikum Düsseldorf should
allow effective collaboration across studies and support the
implementation of all applicable laws and guidelines for the
realisation of clinical studies.
The spectrum of services includes the following:
s Support of reporting procedures within the LVR
s Study coordination in situ (pre-screening, screening,
recruitment, scheduling, recall, etc.)
s Supervision of study patients
s Support of investigators to realise studies according to
the study protocol (assessments, interventions, etc.)
s Creating and monitoring the compliance of internal
SOPs
s Advice on questions relating to AMG, GCP-V and
ICH-GCP
s Drug accountability
s Documentation and data entry
s Sampling and sample logistics
s SAE reporting
s Preparing and supporting monitor visits
s Statistical advice and support for analyses