Large-Scale Integrating ProjectSEVENTH FRAMEWORK PROGRAMME

THEME 1: HEALTH

Optimization of Treatment and Management of Schizophrenia in Europe

General Assembly Meeting1 September 2010

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

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 1st 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 1st (all WP

leaders) SEE DELIVERABLES

Deliverables first year• WP3 UniMan: Functioning mobile phone-based interactive

system to promote adherence month 6Completed 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 4Information 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 1st • Obtain ethical permission for all sites (expected in

Spring 2011)• start including in all centers (Summer 2011)