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Introduction: In France, the number of hospitals involved in clinical research and committed to a quality approach is increasing. The objective of such approaches is to ensure the safety of patients involved in research projects by improving quality., Objective: The University Hospital of Amiens has chosen to certify all its clinical research activities in the same scope according to the ISO 9001: 2015 standard., Methods: Action planning has been established and a head of quality management has been appointed to oversee this process., Results: The activities in the five departments of our university hospital jointly certified in December 2019, are: activities related to internal and external sponsors, as well as methodology and monitoring of clinical research projects conducted in the Clinical Research and Innovation Department (CRID); help with clinical research investigations in the Clinical Research Center (CRC); management of the pathway of therapeutic units used in clinical research (excluding the manufacture of drugs) in the Clinical Trials Unit (CTU) of the Hospital Pharmacy; the conservation and provision of biological resources (tissues and fluids) for cancer research in the Tumor bank of Picardy; the collection, reception, preparation, quality control, conservation and provision of biological resources for research purposes. These activities fall within the framework of legal and regulatory activities and the provision of secure storage in the Biological Resources Center already ISO 9001 certified since 2004 and NF S96-900: 2011 certified since 2009., Conclusions: The choice of a common quality approach has brought together more than 70 persons from 5 departments involved in clinical research projects within a single certificate with the aim of continuous improvement., (Copyright © 2022 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.)

OLGA (which stands for "Activity Management Tool" in French) is a digital management platform developed by F-CRIN, the French Clinical Research Infrastructure Network, which was set up in 2012 to improve the performance and attractiveness of clinical research in France. F-CRIN currently represents a community made up of 21 different components - thematic research, investigation and research networks with a national scope - bringing together the equivalent of 1,500 clinical researchers and 400 research centres all around the country and belonging to many different organizations. Faced with the difficulty of gathering uniform collective data that meet the requirements of F-CRIN's supervisory authorities, in 2015 the F-CRIN community decided to develop a specific monitoring and management tool. Designed with input from its future users, OLGA currently has two modules: one for the components' research activity and the other for their financial operations, resources and expenses. These are able to take account of the activity of the components in all their diversity and produce various sets of indicators. Other features, including a space for sharing documents, are currently being developed. Today, OLGA is a reference tool for managing large-scale, complex organisations., (Copyright © 2022 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.)

Background: The Clinical Investigations Center of Saint-Louis Hospital (CIC-1427) is a structure dedicated to clinical trials and mainly early phase trials (first-in-man administration, phase 1 and 2). These trials are conducted in a French Regional Health Agency (ARS) authorized structure. In March 2020, faced to the global COVID-19 pandemic and the French national lockdown measures, the CIC-1427 had to rapidly adapt its operating procedures to ensure the safety of both patients and staff., Study Objective: Ensuring optimal management of patients included in early phase clinical trials, while respecting the good clinical and professional practices (GCP/GPP) of the CICs protocol sponsors' requirements, patients' safety and clinical research multidisciplinary staff safety (nurses, caregivers' assistants (AS), clinical research assistants (CRA), clinical trial coordinators (CTC), project leaders, health executive and investigating physicians), in the context of the health crisis related to COVID-19., Methods and Results: Due to their activity, requiring on-site presence, each staff member of the CIC-1427 clinical research team had to adapt their daily activity to the constraints of the health crisis. New specific procedures were quickly developed to deal with the pandemic. Most of the on-site medical visits were replaced by virtual consults with biological assessments in the local laboratories. "Remote monitoring" replaced on-site monitoring visits. Treatments were sent to each patient's home via couriers after agreement of the CPPs of each protocol (Committee for the Protection of Persons). The essential visits were maintained on site thanks to the unfailing involvement of our clinical care team, with implementation of a specific sanitary protocol., Conclusion: The involvement of our entire multidisciplinary research team ensured that each patient was able to benefit from a personalized follow-up and to continue the treatment on-trial. The newly introduced procedures also allowed collection of a maximum of safety and efficacy data for clinical trial sponsors while complying with good regulatory practices. This set of procedures developed during the first epidemic wave, fundamentally helped setting the frame for a better coping during the subsequent pandemic waves., (Copyright © 2021 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.)

Clinical investigation at the University Hospital of Nantes is carried out within the investigation department, which consists of coordination and 24 clinical research teams gathered at four different hospital sites. The Clinical Investigation Units are all equipped with a Quality Management System. This has been in place for more than 12 years and was initially created for the Clinical Investigation Units of the Clinical Investigation Centre (CIC 1413) in Nantes and then transposed in 2013, to the emerging Clinical Investigation Units., Objective: In order to evaluate the performance of this quality approach applied to all UHC investigations, the Investigation Department is committed to obtaining an ISO 9001:2015 certification., Methods: The quality division of the investigation department conducted the project according to a methodology, based on internal and external evaluations to determine an inventory and the retro-planning of the certification approach., Results: The scope of the certification involved the investigation department of the University Hospital: 24 clinical investigation units, over 500 medical staff, 150 non-medical staff. In our certification approach, the client was the promoter of the clinical study. The process lasted 18 months and included phases of training and awareness-raising for all the staff involved. The quality management system of the investigation department has been revised and improved in accordance with current regulations. The Investigation Department obtained the ISO 9001:2015 certification for all clinical investigations at the Nantes University Hospital in June 2017 without any non-compliance., Conclusion: Our work shows that the investigation department has successfully adapted the ISO 9001:2015 standard to institutional clinical research. The certification for specific activities in clinical investigation is the guarantee of an optimized and relevant organization for the safety of volunteers, participating in clinical research as well as the scientific quality of the research and contributes to the satisfaction of sponsors., (Copyright © 2019 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.)

Beyond the application of legal requirements, clinical trials must have a permanent approach of quality control. The clinical investigation centers (CICs) are academic structures of clinical research certified by the French National institute of health and medical research (Inserm) and whose functioning relies on recommendations of good practice. It is important to accompany this standardization of practices by the implementation of a quality management system. This article presents the process that enabled the CIC of Rennes to become certified ISO 9001 by French standards association (Afnor) certification in May, 2016. The application of the fundamental principles of the standard ISO 9001 in the domain of clinical research is approached. The problem of the perimeter for the certification and the related process mapping are exposed. The activities of methodology, management and analysis of clinical studies were chosen for the initial certification of the CIC of Rennes. The perspectives for the extension of the perimeter of certification are also approached at the end of article., (Copyright © 2018 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.)

French clinical investigation centers (CICs) are academic platforms dedicated to clinical research. The QUALI-CIC working group helps to improve and harmonize practices within the CIC network. After some years of implementation, the manual of good professional practices of CICs (MGPP CIC) completed in 2010, needed to be revised to best fit with the large panel of CIC activities. The aim was also to make it more accurate and to reinforce requirements about participants safety and data security. In its second version published in the present article, the MGPP CIC includes 255 items divided into 15 chapters. An explanatory document, currently being drafted, will complete the manual to facilitate its implementation., (Copyright © 2017 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved.)

Clinical Investigation Centres (CICs) are academic organisations for performing clinical studies. They are a part of a national network which is co-ordinated by French national institute for health and medical research (Inserm), and the head office of healthcare provision (DGOS). There are working groups and specialised networks within the overall CIC network. The Harmonisation of CIC Procedures (HPCIC) group wrote a manual of good professional practices for clinical research. This manual is described here. This manual was written by consensus. It was approved by the coordinators of all CICs, external experts, and validated by representatives of both Inserm and the General directorate of healthcare provision (DGOS). The CIC Good Professional Practices manual is a guide divided into two sections. The first section covers the general management of a CIC (common to all CICs). The second section covers the core activities of CICs, running clinical studies (clinical study coordination, clinical investigation, data management, statistical analysis, valorisation). This manual is available for all CICs and any other clinical research organisations. It will serve as a basis for CIC self-quality evaluation, audits between CICs, and external audits. This manual shows how much the CICs want to standardise practices and procedures nationwide to offer their partners the best quality in performing clinical studies., (Copyright © 2012 Société Française de Pharmacologie et de Thérapeutique. Publié par Elsevier Masson SAS.)

Since the full implementation in France of the European Directive 2001/20/EC about biomedical research, a written information form must be given to any participant in research, who must give in return his / her written consent. The written and consent form must be validated by a referent ethics committees prior to the research, but guidelines for the redaction of such document are missing. Thus, the investigators who are often in charge of the redaction could be helped by a tutorial that may consider the legal aspects, the rights of the participant and the quality of information. For this, a group from the French network of the clinical investigation centres - directed by the Inserm - worked on a tutorial which is presented here. This tutorial has been built stepwise, with review of the literature, enquiry within the French clinical investigation centres, primary redaction, internal validation, and final validation by external experts versed in the field of ethics for biomedical research., (Copyright © 2010 Société Française de Pharmacologie et de Thérapeutique. Publié par Elsevier Masson SAS.)