WP6 – Management and coordination

Objectives:

1. To efficiently manage and monitor the progress of the project, including financial management, ethical oversight, and reporting to the European Commission.

2. To establish and maintain internal and external Boards and prepare all Board meetings.

3. To ensure effective and FAIR data management.

Description:

WP6 coordinates and manages all administrative, legal, ethical, and financial, aspects of the project.

IDIBELL will be establiched as the Financial Coordinator and will be responsible for all financial aspects of the project and all corrispondence with the European commision.

UoH will be established as the Scientific Coordinator and will work in close collaboration with the Financial Coordinator.

A Project Office (PO) will be established at UoH, including the Scientific Coordinator, a project manager and support staff.

The PO is responsible for central, day-to- day operational management and smooth and timely execution of the project, acting as an accessible helpdesk and consultation and communication point on all matters related to study conduct. In addition, the PO is responsible for assisting the General Assembly (GA), Steering Committee (SC) and the boards of external advisers (Scientific Advisory Board (SAB), Ethics Advisory Board (EAB), Impact Advisory Board (IAB)) on all operational management issues. Data management will be led by (UULM), IDC, and the PO.

Task 6.1 Overall coordination, quality procedures, and risk management (M1-M60)

Lead partner and participants UoH

• The General Assembly (GA), as the strategic and ultimate decision-making body of the project including any aspect affecting the Consortium Agreement and/or Grant Agreement, comprises one representative per beneficiary. The GA is responsible for quality and progress monitoring, financial monitoring, overall risk management, conflict resolution and decisions on any corrective measures in case of (un)anticipated contingencies, including resolving any disputes.

• The Steering Committee (SC), consisting of all WP leaders and chaired by the Coordinator, is the central management team and supervisory body for execution of the project. The SC is responsible for overall monitoring of the scientific and financial progress, based on the agreed deliverables and milestones, monitors and facilitates alignment between WPs and organizes all management meetings (assisted by the PO).

• The Project Office (PO) implements standard quality procedures, including meeting procedures, a guide on reporting procedures, standard procedures for data collection and procedures on conflict mediation and corrective actions. The PO will use the Clinical Trials Support Network Quality Management System adapting Standard Operating Procedures where necessary.

• All study documentation will be managed via an electronic Study Management File (SMF) housed behind University firewalls, meeting all relevant GDPR standards and with daily secure backup. All current study related documents will be housed on this platform, and access to relevant sections of the SMF will be managed as required for all partners and study staff. This will ensure access to the most up-to-data study documentation as required by each partner.

• A risk register will be created at an early stage during set-up and reviewed on a routine basis (monthly). The register will specify procedures for local management of risk relating to study processes and procedures, and for local management of risk among study participants. For progress monitoring and proactive risk manage- ment, each WP leader will provide quarterly progress reports to the GA and PO, including activities carried out, achievements, risk register updates, and any deviations and updates regarding time schedule and/or costs.

The Financial Coordinator,the Scientific Coordinator, the GA and the SC will continuously monitor progress of the project against the main risks identified, allowing proper risk assessment and timely implementation of any corrective measures.

Task 6.2 Project management, including administrative, legal, ethical, and financial mgt (M1-M60)

Lead partner and participants IDIBELL & UoH

• The PO (located at UoH) will provide oversight of all administration, legal, and ethical management, supporting partners where necessary to deliver the required tasks to time and target. The PO has dedicated offices at its disposal to support the project management team. These include legal advice and support, a finance officer, technology transfer officer, and a person within the local team responsible to oversee and ensure all governance and ethics processes are addressed in a timely manner.

• The Financial Coordinator (loacyed at IDIBELL) will provide all financial management. These tasks will include managing all contracting with the Horizon program, and between study sites.

• Each beneficiary is responsible for their own administrative, legal, ethical, and financial management, with the support of the PO. The PO will provide standardized study documentation to each study site. Study sites will be responsible for adapting the documentation in line with local governance and ethical processes and procedures. This includes responsibility for ensuring that appropriate review and granting of permissions by local Research Boards is completed before any local data collection is started.

• Risk reporting will be established on a quarterly basis, to include study processes and procedures, and risk relating to study participants. Bootstrap is a public health intervention, not intended to treat or manage significant pathological conditions, or significant risk among the young people taking part. The study participants will be monitored for indicators of significant risk to themselves or others, and (1) incidents recorded and reported, and (2) managed appropriately according to the support provided among local services.

Task 6.3 Internal communication (M1-M60)

Lead partner and participants UoH

• The PO is responsible for establishing internal project boards, organizing and preparing meetings and implementing a communication strategy aimed at efficient internal communication. The most up-to-date versions of all study related documentation, including, including protocols, meeting minutes, and lists of study related staffing, will be made available on the electronic SMF. Access to the SMF will be managed by the PO, and sections of the file made available as required.

This ensures all study related staff have access to the most up-to-date study related information. Communication is also facilitated by making online video platforms available to all study related groups as required. Last, the PO is responsible for establishing, developing and maintaining a study Web Site, the content of which will be agreed and revised as required by the GA and SC.

• The GA meets in person or via videoconferencing at least once a year, preceding the reporting obligations to the EC.

The SC meets in person or via videoconferencing at least twice a year.

Task 6.4 Bootstrap external Boards SAB, IAB, EAB (M1- M60)

Lead partner and participants UoH

• The PO is responsible for establishing the external project boards and organizing as well as preparing meetings.

• The Advisory Boards meet in person or via video conferencing once a year. They consist of independent external experts selected for their expertise, network, and/or experience.

Scientific Advisory Board composition (all confirmed, see LoS):

Robbins (CAM UK, foremost expert in translational neuroscience of addiction and compulsion H index >150); Potenza (Yale, USA specialist in addiction, PUI, child and women’s health); Hollander (Einstein, USA, compulsive spectrum disorders, behavioural addiction, autism, ICOCS chair); Van Ameringen (Hamilton, CA, anxiety, PUI, ICOCS past chair, leads CANMAT clinical anxiety guidelines); DellOsso (Milan, IT, Editor of the EU-PUI self-help e-book ‘How to Deal with PUI’); Lochner (Stellenbosch SA; mental health and addiction in low and lower middle income countries); Geller (Massachusetts Gen H, USA; compulsivity in childhood and adolescence); Higuchi (Kurihama Medical and Addiction Center, JPN) (PUI in East Asian cultures)

Impact Advisory Board composition (all confirmed, see LoS):

Saunders (Sydney AUS; works with WHO, responsible for AUDIT questionnaire (standardized self-assessment test for alcohol use disorders); Bijlhout (London, UK; Association for Teacher Education in Europe ATEE); Haller (Brussels, BE; European Parents Association EPA); Zyberi (Oslo, NO; member of the UN Human Rights committee); Stein (Cape Town, SA; psychobiology and management of anxiety, obsessive-compulsive and addictive disorders, risk and resilience and integrative approaches to services, training, research in LMIC); Achab (Geneva CH, WHO Collaborating Centre (WHOCc) for Research and Treatment in Mental Health); Bonnano (University of Malta, MLTA, postgraduate teacher education in PUI); Barrington-Leach (UK; 5Rights foundation); Laniardo (Brussels BE, Terre des hommes); Middleton (UK; Association of Schools of Public Health in the European Region ASPHER); Lando (IT, documentary and short film director) Ethics Advisory Board composition (all confirmed, see LoS): Sahakian (CAM UK, neuro-ethics, Distinguished Fellow Oxford Uehiro Centre for Practical Ethics); Riva (Dublin, IE; Attorney at Law, fellow in Privacy, Ethics and New Technologies); Moreno-Rivera (UoH Law, UK)

Task 6.5 Data management (M1-M60)

Lead partner and participants UULM, IDC, UoH

• UULM will lead provision of a platform where all participant data will be stored, including the self-report data, tracked smartphone data and data from the experimental cognitive tasks. UULM will provide the scientists via a password protected log-in the opportunity to real-time monitor the current state of study participant recruitment at all sites and will permit scientists (to varying degrees) access to and download of the data. We note that logged data on the server will be immutable.

• The platform will be further secured with a firewall and operate from ISO 27001 certified servers and hosting.

Task 6.6 Reporting to the EC (M1-M60) Lead partner (bold) and participants UoH

• Based on the Consortium Agreement, periodic and final reports will be submitted to the SC. PIs of each beneficiary are held responsible for providing the Coordinator and the PO with relevant input, including financial reports, towards the obligatory SC reporting. The Scientific Coordinator ensures reaching out to partners as required. Each report will have a defined frequency, format and list of topics covered.

• All reporting schedules and templates will be available to relevant study staff on the electronic SMF, with access to previous reports enabling consistent management of reporting throughout.

Task 6.6 Reporting to the EC (M1-M60) Lead partner (bold) and participants IDIBELL

• Based on the Consortium Agreement, periodic and final reports will be submitted to the SC. PIs of each beneficiary are held responsible for providing the Financial Coordinator and the PO with relevant input, including financial reports, towards the obligatory SC reporting. The Financial Coordinator ensures reaching out to partners as required. Each report will have a defined frequency, format and list of topics covered.

• All reporting schedules and templates will be available to relevant study staff on the electronic SMF, with access to previous reports enabling consistent management of reporting throughout.