Surgimiento de la medida cautelar en el Derecho de Competencia de la Unión

Duration 60 months Start date Month 1

WP leader C. Libersa

Task leaders V. Journot, D. Bertram, V. Plattner, V. Diebolt Personnel 84 person-months

Operations costs 1040K€

The objectives of this WP consist of developing common procedures and tools for their implementation as nationwide standards in line, as far as possible, with the procedures and tools developed and implemented at the European level through ECRIN. This WP will not ‘reinvent the wheel’, but will take advantage of existing initiatives to select and adapt the best adapted tools and procedures and spread the best practices. These common tools and criteria will be used as criteria for the competitive calls for the creation/upgrade of networks, clinical trials units and data centres.

WP4 is led by Professor C Libersa, Professor of Clinical Pharmacology at the University of Lille and Coordinator of the CIC of Lille, Mrs V Journot is Biostatistician at the CIC-EC of Bordeaux, Mrs D Bertram is a pharmacist in charge of the pharmacovigilance of the DRCI of the Lyon University Hospital, Dr V Plattner works at the DRCI of the Lyon CHU, and Mr V Diebolt is Director of Cengeps.

WP4 is split into 7 tasks:

Task 4a - Quality assurance

Taking advantage of the work already done within the CIC network and other partners, this task will consist of defining the QA requirements for the various components of the clinical research infrastructures, as well as the cost-effective tools implemented to ensure compliance with the QA policy (self assessment, audits, certification, accreditation, with links with task 2c). A critical issue will be to align this national QA policy with the ECRIN requirements for multinational studies.

The ICH-GCP defines quality assurance and quality assurance has to be reinforced by Quality control.

The ICH GCP are benchmarks dedicated to research on medicines for human use. Given the wide variety of research sponsored by academic sponsors, it is mandatory to have a

Quality Assurance system for all kind of researches, not only those on drugs. To date, there is no reference enforceable in France or in the European Union for other clinical researches. Therefore it seems essential to work on Quality Assurance for all kind of research, and fit the Quality Assurance system. That's why, since 2007, a working group, issued from the CNCR gathering the 7 DIRC from 20 CHU (DRCI representatives) works on the quality of academic sponsoring with the following objectives:

- To establish Quality Assurance for all types of clinical researches adapted to the nature of the trial.

- To harmonize procedures to conduct multicentric academic clinical trials.

The objective of the group is to find a consensus on a basic set of standard operating procedures for all types of researches and of the processes according to the follow up of the trial (before the beginning, during and at the end of the trial). The group's work has focused on the harmonization on common rules for audits of informed consents and Monitoring procedures adapted to the different national studies with a future extension to European management and will extend the project to the other procedures

Task 4b – Study management .

Development of a national study management tool for academic clinical research, in close cooperation with the tool currently being developed (SIGREC) and of common costing and contracting template, adapting to academic trials the LEEM-FHF initiative (cf task 3a). This web application SIGREC has been developed by the Lille University Hospital allowing exportation and import in (or from) other databases by the sponsors to have access to the identification of clinical trials and to the progress of the inclusions in clinical trials.

In complement of this basic software various softwares have been developed for pharmaceutical firms or academic institution (eg Inserm) to allow diary follow up of the trial in terms of study data, patient visits management, study supply, CRFs and DCFs tracking, SDVs tracking, files management, recruitment plan follow up, sub-contractors management, study material follow up, alerts, queries editions, specific reports definition, graphic production, study cost management, management of patient/center data

This framework makes mandatory development of common export formats with secured incrementation.

Task 4c – Pharmacovigilance

The objective of this task is of the specification for certification of pharmacovigilance / adverse event reporting for academic clinical research, to be included in the criteria for the call for the creation / certification of CTUs.

In 2001, the Clinical Trial (CT) directive (2001/20/EC) deeply reinforced the responsibilities of the sponsor regarding pharmacovigilance for clinical trials on medicinal products mainly trough the implementation of the European phamacovigilance database (Eudravigilance) and of the annual safety reports. An academic clinical trials safety working group (REVISE: groupe de REflexion sur la VIgilance et la Sécurité des Essais) was created in 2007 on behalf of the French Hospital Federation (FHF) and of the French Academic Sponsor

Coordination (CPI). REVISE gathers more than 80% of the French University Hospitals’ safety clinical trials departments and the majority of French non-commercial sponsors. This French academic working group includes over 40 stakeholders.

Until now, this group has established guidelines, common procedures, common material for training and education, common costing and contracting templates for pharmacovigilance. This group had also organised MedDRA training sessions (≈ 60 persons attended).

Task 4d - Monitoring

The objectives of this task are to facilitate the implementation of the risk-based approach in monitoring activities, in line with the ECRIN strategy, the OECD recommendations, and the European guidelines currently being developed for the revision of the CT Directive to be included in the criteria for creation / certification of CTUs.

Task 4e – Regulation, GCP, ethics.

The objective of this task is to develop a comprehensive and permanently updated database on regulatory and ethical requirements. This will result in a user-friendly e- repository both in French and English language, developed in cooperation with AFSSaPS, and coordinated with the regulatory database and repository developed by ECRIN (there are some existing models16_{, but the tool should be easy to use for national and} international users).

Task 4f – Interface with industry / CeNGEPS

The objective of this task is to develop common strategy for the development/up-grading of disease-oriented investigation networks, for the co-development of costing, contracting, and study management tools as well as information and communication targeting national and international industry partners (medicines, biotechnology, medical devices), and with PPP funding sources (bio-clusters (pôles de compétitivité), IMI).

Task 4g – Interface with BRC network:

Clinical trials generate numerous biological samples which need to be manage in respect with strong procedures of conditioning and preservation.

The French biobanks and BRCs infrastructure have undertaken a project (project BIOBANQUES) to increase resources level of coordination and efficiency of French collection of biological, by setting up a sustainable infrastructure that will provide new services, better access for users from public and private sector, develop public private partnership and interface with the pan European infrastructure BBMRI and EMBARC/MIRRI.

The interface between F-CRIN and project BIOBANQUES will be mandatory to contribute to increase the scientific excellence and efficacy of French research in the biomedical                                                                                                                          

sciences as well as expand and secure competitiveness of European research and industry in a global context and attract back investments in pharmaceutical,