Move to an optimal situation Research in RIJNSTATE

Move to an optimal situation Research in RIJNSTATE

Move to an optimal situation
Research in RIJNSTATE (STZ)
Marc Rinkes, PhD
R&D Manager, Rijnstate Hospital, Arnhem
Member STZ Scientific Advisery Board
Take home message
STZ hospitals,
reliable and serious partners in research
Subjects
Rijnstate research infrastructure
STZ framework
Rijnstate?
Hospital group of 5 locations: Arnhem, Zevenaar, Velp,
Arnhem-Zuid and Dieren
Hospital care of top clinical quality: high quality diagnostics,
therapy en care
One of the biggest care providers of the Netherlands
Research organisation
Decision-making
Board of Directors / Medical staff
Policy-making
Central Scientific Committee
Executive and expertise
Investigators
supporting staff
•Central Research bureau
•Trial bureau
•Clusters of research staff
Scientific focus
Areas of interests
• Oncology
• Mother and child
• Vulnerable elderly
• Immunology
• Vascular diseases
Centers of expertise
• Gout
• Diabetic patient
• Pain
• Bariatric patient
• Vascular surgery
• Electro convulsion therapy
Focus
Inv IR
Registry
CSC
Ind IT
Collabo
-ration
EXPERTISE &
CONDITIONS
Professionalization
QA
GCP training
Fundraising
Promotion
R&D dept
PROCEDURES
Local feasibility
SHOP
Trialbureau
Trialportal
Trialservices
Tripartite contract
Study start up
Approach R&D
BoD
Approval
contract
SSU
Idea
First contact
Loc. Feasibilty
‘light’
Trialcoordination
Initiation
Study
End of
Study
Rijnstate House style
• GCP certificate required
In collaboration with R&D department
•
•
•
•
Jointly Study Start Up
Support ‘Guide line External Review’
Local feasibility ‘light’
Tri-partite contract & negotiation
Harmonization of
research infrastructure
Common Policy
Clear set of visitation criteria
STZ, 3 oktober 2012
STZ infrastructure
Operational
• Central Research bureaus in each hospital
• Implemented Local feasibility guide line (procedure 4-6w)
• Common set of SOPs
• Certified GCP course required for investigators
• Regional cooperation Research bureaus
In preparation
• Transparent research organisation
• Education of Research nurses
• Tripartite contract
10
STZ, 3 oktober 2012
Pharma and CRO
Regional Trialportal
Discussion
How to stimulate
- ambition of local investigators and hospital?
- collaboration with university hospitals and/or industry?
•
•
•
•
•
•
•
•
Trial participation
(continuity)
Innovation agenda
(match)
Trial infrastructure
(improvement)
Authorship
(clear agreements)
Member of DSMB / steering committee, etc.
Data for own research
(use)
Phase 2 studies
(stimulation)
Investigator Initiated research
(stimulation)
Regional cooperation
(stimulation)
Thank you!
Marc Rinkes, PhD.
[email protected]