Network Charter

Article 1:

This charter defines the goals of GIRC Thrombose France and the rules applicable within the network. It may be modified if future goals change.

Article 2:

All members of this network will sign and comply with this charter.

Article 3: Network Introduction, Mission and Goals:

GIRC is a national clinical research network of health professionals (individuals or legal entities) who specialise in the field of Venous Thromboembolic Disease (VTED). It aims to promote clinical research by conducting multicentre trials and networking with French investigators, and by helping them participate in national and international, institutional or industrial research protocols within the framework of the law and Good Clinical Practice.
The network’s purpose is to

• Coordinate research efforts
• Open new investigating centres and create a single-entry system to help the industry and other partners design and conduct clinical trial projectsImprove communication between professionals
• Provide professionals with information on thrombosis and clinical research
• Raise public and private funds
• Promote cooperation between the network and INSERM units specialised in haemostasis research
• Collaborate with biobanks

Article 4: Resources:

The organisation's resources consist of monetary resources (from CENGEPS and INSERM invitations to tender, members' annual fees, any public and private funding, donations and bequests) and investigating centres resources (staff, methods, equipment...).

Article 5: Coordination and Piloting Committee:

GIRC Thrombose France is coordinated by its president, who is a clinical investigator. He is elected at the General Meeting.
The network coordinator is assisted by a piloting committee of network members.
The piloting committee is the GIRC Board of Directors, elected at the general meeting.
It includes 3 vice-presidents, one secretary, one treasurer and active members. Board members are elected for 4 years.
The piloting committee is assisted by a coordination team: one animator in charge of network coordination, one IT specialist in charge of the website, and one animator in charge of the "Réseau d'Investigation de Recherche Clinique Public et Privé".

Article 6: Role of the Coordinator, Decision-Making and Information Sharing Processes, Resource Pooling:

The network coordinator can name a focal person who will act as the only exterior contact for a particular trial.
The coordinator's missions are as follows:

• To look for and recruit new network members and update the membership directory
• To develop tools for continuously assessing and sharing clinical investigation activities within the network (e.g. website, newsletter, executive dashboards) while ensuring that all shared information remains confidential
• For a given trial, to assess available resources and project feasability in the various network centres who wish to participate (e.g., human and material resources, recruitment capacity) and to ensure that previsional costs have been correctly calculated
• To develop a policy of continued training, for network members or their staff, in the following fields: scientific & GCP ; laws & regulations; methodology & technology

Decisions regarding investigator tutoring, information confidentiality and resource management are made by the coordinator. Decisions regarding general policy and goals are made by the board following a co-decision procedure. Information on network activity is shared through e-mail. This includes newsletters and other communication materials. The network animator centralises the information and then shares it with institutions which require it (e.g., CENGEPS.) He/she asks network members about the degree of confidentiality attached to the information they provide him/her with.
Trials and their results are archived (bibliography, publications.)

Article 7: Network Members Commitment:

To enter this organisation, aspiring members must:

• Be sponsored by two members of the organisation
• Be approved by the board, which will consider candidates for membership at each of its meetings

By accepting to be a member of this network, investigators commit themselves to:

• Agreeing and conforming to the terms of this charter
• Keeping informed  of all information shared by the GIRC coordinator and responding to his/her messages
• Participating in industrial and institutional clinical trials whenever possible, coordinating or actively participating in the implementation of a study (one study every 2 years)
• Sharing with the GIRC coordinator all clinical trial projects that they receive or initiate
• Pooling human and material resources with GIRC
• Participating or sending their staff to network training programs
• Crediting the network for participation in all publications or communications on clinical trials conducted within GIRC

All members must pay their yearly membership fee, which is set each year at the general meeting.

Article 8: Membership Termination:

Membership may be terminated in the following cases:

• Resignation: All GIRC members may leave the network at any time. They must inform the network coordinator of their departure. This departure is accepted on the condition that it will not impede an ongoing clinical trial. If it would, the coordinator may require of investigators that they postpone their departure until completion of clinical trials in which they are participating.
• Expulsion: Expulsion may be decided by the board in cases of serious misconduct. Prior to expulsion, members will receive a summons by registered mail and explain their conduct to the board. The coordinator and/or piloting committee may also decide to expel a GIRC member who does not comply with the charter.
• Death

Article 9: Rules for Conflict Management:

Any doubt, disagreement or conflict must be declared to the network's coordination centre, which may convene a meeting of the GIRC board of directors to address it. Any situation can be managed in an open, communicative manner in compliance with GIRC values, so as to reach consensus.

Article 10: Databases:

VTED, on which this network conducts research, is an emergency pathology. Therefore there can be no up-to-date database of potential trial participants (patients or healthy volunteers.) We can only establish an ex-post-facto register of cohort study participants.

Article 11: Network Lifetime and Dissolution:

GIRC Thrombose - France was created with no foreseeable dissolution date. However, the coordinator and board may decide to dissolve the network. The details of dissolution and allotment of GIRC means and resources are decided by the coordinator and board. The coordinator must inform investigators involved in ongoing clinical trials and any funding organisation. Within 3 months following network dissolution, he/she must provide all parties concerned with an activity report and a financial statement informing them on resource allocation concerning funding received by GIRC.