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Large-Scale Integrating Project SEVENTH FRAMEWORK PROGRAMME THEME 1: HEALTH

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 :

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Large-Scale Integrating Project SEVENTH FRAMEWORK PROGRAMME THEME 1: HEALTH

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  1. Large-Scale Integrating Project SEVENTH FRAMEWORK PROGRAMME THEME 1: HEALTH Optimization of Treatment and Management of Schizophrenia in EuropeGeneral Assembly Meeting1 September 2010

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

  3. 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)

  4. 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)

  5. 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)

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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 1st 2011 (+ max 60 days)

  12. 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)

  13. 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 1st (all WP leaders) SEE DELIVERABLES

  14. 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

  15. 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

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

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