Large-Scale Integrating Project SEVENTH FRAMEWORK PROGRAMME THEME 1: HEALTH Optimization of Treatment and Management of Schizophrenia in Europe General Assembly Meeting 1 September 2010

Where are we now? Legal issues: Agreement with EU on the Description of Work and starting date: February 1 st 2010 Consortium Agreement: awaiting final approval, almost ready to be signed by all Partners

Where are we now? Practical issues: Participating centers defined per WP Overall protocol for WP1,2,3 and 5 First centers have submitted to medical ethical boards Website finished Logistics for WP1,2,3 and 5 ready eCRF almost finished (see next slides)

Data management e-CRF: Research Online – e-CRF system developed by Julius Center (UMCU) 95% of all questionnaires implemented Site for acceptance testing implemented (workflow, layout)

Data management (2) Randomization: Online randomization system Minimization method Implemented for WP2 and WP3 – Integration with medication logistics Subject numbering: Assigned by e-CRF at inclusion Provisional list of ranges per center (waiting for final list of centers)

Where are we now? Financial issues: Pre-financing from EU received by UMC Utrecht This will be divided over the partners as soon as the Consortium Agreement is signed by all partners Payments for other years will be partly based on # of inclusions and items performed

Changes from the plan WP4 (CBD) will start 12 months later JCR cannot be added as a third party/partner and will therefore not perform the monitoring for WP2 (meds) Inge Winter-van Rossum will lead the monitoring directly from UMC Utrecht Training of personnel in small groups of 2-3 centers in Amsterdam shortly before inclusion starts in those centers

What will be the next steps? Legal issues: All partners sign the CA (Autumn 2010) Several adjustments to the Description of Work (DoW) are required This new version of the DoW will be resubmitted to the EU After EU approval: new version of Consortium Agreement to be signed by all partners, and amendments to the Grant Agreement when applicable

Suggested changes for DoW Other centers that participate in WP1 (MRI) Mannheim will not participate in WP1,2,3,5 Centers that want to add third parties/ subcontractors (mainly for MRI) JCR is not a partner/third party anymore Some changes in budget in accordance with activities of the centers

What will be the next steps? Practical issues: Obtain National and local medical ethical permission in all centers Translate patients information, researcher manual and motivational interviewing Train personnel for PANSS, eCRF and motivational interviewing per 2-3 centers

What will be the next steps? Financial issues: We are preparing a schedule for payment per inclusion, according to the number of items performed Some rearrangements in the budget need to be made according to the activities per center First report to the EU on deliverables year 1, due February 1 st 2011 (+ max 60 days)

Responsibilities management team Provide information for ethical submission Provide database and support for data management Change and submit Description of Work Disperse Consortium Agreement to be signed Payment Coordination overall study aspects (e.g. reporting to EU)

Responsibilities WP leaders Calibration MRI,training of personnel (WP 1) Training of personnel PANSS (WP2) Training and translating psychosocial intervention(WP3) Finish protocol and logistics (WP4) Logistics and facilities blood samples (WP 5) Write investigator manual Progress reporting to EU February 1 st (all WP leaders) SEE DELIVERABLES

Deliverables first year WP3 UniMan: Functioning mobile phone-based interactive system to promote adherence month 6 Completed psychoeducational package for delivery over interactive system, developed with users and carers month 6 WP6 SERMAS: Plan for the Use and Dissemination of Foreground month 4 Information paper issue 1 about the project to governments and all interested stakeholders month 13 WP7 UMCU: Creation of an OPTiMiSE logo (√) and brochure month 3 OPTiMiSE web site month 6 (√) Periodic EC report first period (Activity report, Management report, report on distribution of EC contribution) month 12

Responsibilities Partners Translate patient information letter, researchers manual and motivational interview Obtain National ethical approval Obtain local ethical approval Assign personnel for training Start inclusion Delivery of required reporting documents to Coordinator

Mile stones next 6 months First inclusion (expected in Israel this autumn) Consortium Agreement signed by all partners First report to EU February 1 st Obtain ethical permission for all sites (expected in Spring 2011) start including in all centers (Summer 2011)