Governance
Governance

Governance

The organization of the CIC 1417 is subject of a partnership convention between different regulatory authorities: INSERM, AP-HP, The Pasteur Institute, the University of Paris that oversee the CIC and habilitate it to work on various projects. 

The CIC is based on two instances: The Scientific Council (SC), that allows the engaging of a global strategic vision of the CIC 1417 and The Technical Comity (TC), that guarantees the conduct of all clinical trials processes within a legal, ethical and technical framework. 

The Scientific Council (SC) is the scientific
decision-making organ of the CIC Cochin-Pasteur

It consists of the CIC itself and external members that aim to define a strategy and a long-term vision for diverse researches. The SC competences concern different missions

01.

It has for mission to define the strategic orientations, as well as scientific policies with its partners (INSERM, AP-HP, The Pasteur Institute, The University of Paris)

02.

It adjudicates on every presented project and evaluates its scientific relevance, ethics, as well as its adequation with the decided strategic orientations

03.

It validates the functioning and the financial report of the CIC Cochin-Pasteur

04.

It appreciates the adequation between means allocated by the CIC Cochin-Pasteur and its activities

05.

It formulates its recommendations on the activities of the CIC Cochin-Pasteur and on the future evolution of it,

SC meetings can be punctually decided at the request of the coordinating doctor of the CIC Cochin-Pasteur and lead to an opinion or arbitration concerning budgetary and/or scientific questions on a specific project.

The SC is consisted of nine permanent members,
with each having an alternate member

01.

A representative from the hospital group Cochin – Broca – Hôtel-Dieu, appointed by the president of the Consultative Medical Comity (CMC) of the Cochin Hospital

02.

The President of the CMC of the Cochin Hospital

03.

The dean of the Faculty of Medicine of the University of Paris

04.

A representative from the Faculty of Medicine appointed by the dean

05.

The Department for Clinical Research and Therapy (DCRT) Director from the INSERM

06.

A member from the Medical Direction of The Pasteur Institute

07.

A representative from the Federative Research Institute Alfred Jost

08.

A representative from the Interregional Delegation for Clinical Research (IDCR) of the Île-de-France region appointed by the AP-HP

The members of the SC meet once a year on request of the coordinator of the CI. The half plus one is needed to conduct and maintain a meeting.

The Technical Comity (TC) is internal to the research center and gathers often.
The TC has as a mission

To evaluate the methodological and scientific quality of projects

To evaluate the projects feasibility and help formalizing them

To assure the participants security

To decide the implementation of the research project

To coordinate the CIC components for the project realization

The expertise being multidisciplinary and
requiring that every CIC competence is represented, the TC is composed of different members

The coordinator of the CIC (president of the TC)

The delegate doctor

All investigators

All clinical study coordinators (CSC)

All State-registered nurses (SRN)

All clinical research assistants (CRA)

All the projects coordinated or realized by the CIC, regardless of the sponsor, must be submitted to the TC before their submission to the authorities or their implementation. The clinical and scientific relevance of a project, its originality, its ethical and regulatory aspects, its methodology and feasibility are evaluated. The participant’s security participating in a research also remains one of the main aims of the TC.

Quality approach

Quality approach

The CIC Cochin-Pasteur is subject to regular quality follow-ups. The CIC 1417 acquired the certification ISO 9001 for its clinical research activities. Were taken into account the project management, the coordination, the realization, the follow-up quality and the closure of the research.

Recognizes that the CIC Cochin-Pasteur (CIC 1417) respects all ethical and reglementary principles at all stages of research, in particular the patients’ security, the confidentiality and the reliability of the data

Appreciates the professionalism of its team in the conduct of research in vaccinology (from phase I to phase IV) for the evaluation of preventive or therapeutical vaccines

This certification testifies to the engagement of the CIC Cochin-Pasteur in an approach allowing him to entirely satisfy the demands of its clients and partners

This approach has received the support of the INSERM and the AP-HP

Being the only center dedicated to research in vaccinology, the CIC Cochin-Pasteur has all the skills to implement biomedical research, from its initiation to the achieved results appreciation

It ensures the good execution of research protocols from phase I to phase IV for the evaluation of preventive and therapeutical vaccines

The CIC is a privileged structure for the development of new vaccines in collaboration with academical or private promoters. It is a structure labelled by the INSERM and subject to a partnership between INSERM, the AP-HP, the University of Paris and the Pasteur Institute

.

The certification

ISO 9001 : 2015