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

s Archiving study documents
s Supporting collaboration with CCS (see below, noncommercial
studies)
In non-commercial studies, the cost-effective close
collaboration with the Coordination Centre for Clinical
Studies (CCS; Director: C. Ohmann) of the Heinrich-Heine
University is obligatory in most cases. Collaboration is based
on a standard quality assurance with joint SOPs. The SOPs,
available in the CCS, are made available by the Study Service
Centre for this purpose.
Support of pharmacological studies
Since the foundation of the Study Service Centre in 2008, the
following pharmacological studies have been supported:
s The effectiveness of the ENLA weight management
programme in the prevention of weight gain in
patients with schizophrenia treated with olanzapine:
a randomised multi-centre controlled open study
(ENLA = Exercise Nutrition Learning Accepting) (ENLA
study)
s Efficacy and Safety of Vivitrol® in Adults Completing
Inpatient Treatment for Alcohol Dependence (VIVITROL
study)
Study report, insurance certificate
and conditions. Ethics elements,
approval by BfARM, cost calculation,
explanation and declaration of
consent
SSZ Study administration
Sign all documents with letter
from SSZ director and A3
information form for LVR
After positive
decision
Medical director
Signature on test plan,
A3 information form LVR
Board
Rheinland State Association (LVR)
LVR assessment
Board
Figure 26: Planning phase (III) of a study: Approval and reporting (internal)
Local study director
Finance department
Contract checking
Board
Signature
SSZ study administration
ReseaRch
s A 48-Week, Multicenter, Randomized, Double-Blind,
Parallel-Group Evaluation of the Comparative Efficacy,
Safety and Tolerability of Exelon ® 10 and 15 cm Patch
in Patients with Alzheimer’s Disease Showing Cognitive
Decline during an Open-Label Treatment Phase
(OPTIMA study)
s Evaluation of the efficacy and safety of methylphenidate
in adult patients with attention deficit syndrome and
hyperactivity
s Open, prospective clinical testing of the investigation
of the tolerability, safety and efficacy of flexible doses
of paliperidone ER in patients with schizophrenia
(PERFlex)
s A double-blind dose-titration study investigating the
safety, tolerability and pharmacokinetics of multiple
doses of JNJ-x administered once or twice a day to
male and female patients with stable schizophrenia
s RISSCH-4091 Risperdal® consta®: Post-acute
treatment of patients with schizophrenia with
Risperdal® consta® in outpatient units
Report to local authorities,
if not done from sponsors
With assistance from
SSZ, if necessary
Non-commercial studies report to
www.clinicaltrials.gov
Release of study programme and dispatch of
partially completed F3 (report form)
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