MAQ DRC - Version EN

QUALITY MANAGEMENT MANUAL

Clinical Research Division (DRC)

Version: 2026-02-02

DISCOVER >

TABLE OF CONTENT

Gustave Roussy : Presentation

Clinical research in Gustave Roussy

Quality Management System (QMS) : Overview

Quality Policy of the DRC

QMS Management

Appendices & Glossary

gustave roussy : PResentation

1. Gustave Roussy in a few words

2. Organizational chart

1. Gustave Roussy in a few words

Gustave Roussy is a center of care for patients with all types of cancer. It is also a center of research and teaching. The personnalized care for patients is a combination of innovation and humanity. It takes into consideration the physical, psychological and social quality of life of the patient. The Institute has an expertise in rare forms of cancer and complex tumors.

Gustave Roussy

First Anti-Cancer Center (CLCC in french) in Europe & Affiliated with the UNICANCER Federation

A FEWNUMBERS

660

Physicians

1230

Carers

3300

Trained students

1400

Research personnel

2024 number references

2. Organizational chart

Ressources and Development

Communication and Philanthropy Department

International Patients

Perrine de Longevialle

Rémi Thiolet - Axel Le Cesne

Gustave Roussy Fondation

Subsidiaries (GRT...)

CEO

Fabrice Barlesi

Communication and institutional Relations Department

Anne Paoletti

Sylvie Vormus

COMEX

Deputy CEO

Sylvain Ducroz

Medical Director

Research Director

Françoise Rimareix

Fabrice André

CODIR

Yaël Gliksman

Stéphane Chaillou

Nelly Vérotte

Marie-Cécile Mocellin

Christel Dubroca

Administrative and Technical ressources Unit

Technical services and investments Division

Purchases

Digital transformation and Information systems Division

Legal Division

Fabrice Ratsimiseta

Human Ressources Division

Financial affairs Division

Clinical Ressources and medical strategy Unit

Clinical Research Unit

Clinical Research Division

Benjamin Besse

Medical Division

Projects and Sponsorship Office

Françoise Rimareix

Biostatistics and Epidemiology Office

Care Division

Quality Office

Committees

Marie-Claire Marty

Clinical Operations Office

Valorization and Partnerships Office

Quality, Risk Management and Patients Division

Research administration

Jane Khoury

Operations Division

Translational and exploratory research Unit

Nicolas Billot

Mixed research groups

Departments

Technological platforms

Hosted teams

International academic network unit

Karim Fizazi

Cancer Core Europe

International partnerships

Alumni

Teaching and University liaison Unit

Eric Deutsch

Gustave Roussy Education

Pierre Blanchard

Version 04/2024

CLInical research in gustave roussy

1. A few numbers

2. DRC Organizational chart

3. Missions and activities of the DRC

4. Offices Presentation

• Projects and Sponsorship Office
• Clinical Operations Office
• Biostatistics and Epidemiology Office
• Quality and Pharmacovigiliance Office
• Valorization and Partnerships Office

5. Industrial Partnerships

1. A few numbers

25%

of patients monitored for cancer are included in a clinical study

5661

patients included in clinical trials, with

391

patients included in early phases ( I and I/II) phases

Weaknesses

Opportunities

This is a paragraph of text waiting to be awsome content

This is a paragraph of text waiting to be awesome content

The clinical research conducted at Gustave Roussy applies to diagnostics, treatments, sociology, health economy and onco-psychology, as well as any research involving patients.

563

Clinical studies opened to inclusions, with

63

sponsored by Gustave Roussy

145

International publications with an IF > 30

368

International publications with an IF > 10

COMETH Numbers 2024

2. DRC Organizational Chart

General Management

Research Director

Fabrice André

• Internal adjudications
• Projects instructions
• Contrats/Regulations
• Monitoring (GR sponsor)
• Unicancer link

Clinical Research Division

Projects and Sponsorship Office

Benjamin Besse

Guylène Chartier

• Trial design
• Biostatistics
• Data Management
• Epidemiology
• RWD / Medical economy
• Metrics

Biostatistics and Epidemiology Office

Stefan Michiels

• Clinical Research Assistant/Technician
• Clinical Research Nurse
• Committee/ Multi-committee PM
• Screening
• Labs & Images
• AI & Digital

Clinical Operations Office

Valérie Dejean

• Compliance
• Training (GCP)
• Procedures
• Pharmacovigilance
• ISO9001 certification

Quality Office

Delphine Vuillier

Valorization and Partnership Office

• Grant writing
• Article writing
• Data exploitation (clinical/bio.)
• Link between Translational and Clinical Research

Arnaud Bayle

From 08/2023

3. Missions and Activites of the DRC

D R C I

Granted DRCI status by the French Department of Health, the DRC has the following missions :

• Sponsorship (organisation, administration, management, control, technical and regulatory support of clinical studies)

• Methodological assistance, data management and biostatistics (editorial back-up, clinical trial design, database management)

• Organizational assistance in project setup and project submission

DRCI : Clinical Research and Innovation Delegation

The DRCI Gustave Roussy is part of GIRCI Ile-de-France which missions are the training and information of clinical research professionnals and assistance in adjudication responses

The DRC relies on a clinical research management committee and implements :

The industrial policies and the academic partnerships that can reinforce the DRC

The clinical research strategy of Gustave Roussy

The sponsorship of scientific projects and of the institution on the european level

An improvement policy for quality and performances

The connexion between the clinical research teams and the technical platform built around the Research Division

Overview of the DRC activities :

Investigation

Gustave RoussySponsorship

Institutional and industrial sponsors

BPP - BBE - BQ - BVP

BOC

• Design and study follow up
• Data Management
• Pharmacovigilance
• Metrics
• Compliance and GCP training
• Communication and valorization

IndustrialPartnerships

• Study organization on site
• Patients recruitment
• Medical follow-up
• Clinical and biological data collection

4. Office presentation :

bpp

Projects and Sponsorship Office

boc

Clinical Operations Office

bBE

Biostatistics and Epidemiology Office

bq

Quality Office

BVP

Valorization and Partnership Office

BPP PRESENTATION

75 employees

The Project and Sponsorship Office (BPP) is part of Gustave Roussy's ongoing efforts to optimize the performance of its clinical research and to enhance its capacity to sponsor large-scale, high-value national and international academic studies. It also aims to strenghthen Gustave Roussy's position as an expert and reference center for conducting innovative industry sponsored trials. This office is responsible for managing clinical research activities sponsored by Gustave Roussy (protocol writing, submissions to regulatory authorities, operational coordination, logistics management and monitoring). It also acts as a single point of contact to centralize all study proposals in which Gustave Roussy will act as an investigative center, ensuring their swift implementation. Additionally, it manages all contracts, budgets and billing related to clinical trials.

The BPP is divided in 3 teams :

Financial Team

SponsorshipTeam

Project Team

• Single point contact manager
• Single point contact project manager

• Clinical studies Assistant

• Head of Sponsorship
• CRA Manager
• Clinical Projects Manager
• Clinical studies coordinator
• CRA Monitors
• Regulatory Affairs Officer
• Regulatory Assistant
• Clinical studies Assistants

• Contracts and billings managers
• Billing administators

SPONSORSHIP TEAM

Tasks and Goals

• To conduct studies in accordance with the budget, the commitments and the projected timelines as defined in the contracts with industrial and academic partners, and in private or public calls for proposals (such as Hospital Clinical Research Programs) ;
• To ensure the design of clinical trials and to guarantee their operational feasability ;
• To prepare essential documents and submit clinical studies to Ethics Committees and Competent Authorities , in compliance with applicable national and internantional legal and regulatory requirements and implement necessary quality actions ;
• To manage national and international clinical research projects, oversee operational activities and ensure the quality control of clinical studies in order to guarantee patient safety, data quality, compliance with Good Clinical Pratice (GCP) and applicable regulations.

139

4457

projects managed with :

52

patients included in a GR sponsored study (RIPH 1 + 2)

in recruitment, including :

international studies

study in sponsorship delegation

26

698

application files for opinion/ authorization submited by the Ethics Committee (EC)/ Competent Authorities (CA)

amendments submitted to EC/ CA

PROJECTS TEAM - SINGLE POINT OF CONTACT (STARTUP ACTIVITIES)

Tasks and Goals

• Centralizing all clinical trial proposals through a single point of contact to ensure their swift implementation and coordinating all trial start-up activities (confidentiality agreements, site selection, operational feasibility, documentation and contracting) ;

• Centralizing all trial proposals in which Gustave Roussy acts as an investigative site through a single point of contact to ensure their rapid implementation.

FINANCIAL TEAM

Tasks and Goals

• Establishing financial contracts and amendments for clinical studies in which Gustave Roussy acts as an investigative site, including the assessment and negotiation of costs, additional charges and related compensations ;
• Coordinating the management and negociation of budgets and contracts for clinical trials sponsored by Gustave Roussy ;
• Ensuring the invoicing of clinical studies and the payments follow-up ;
• Monitoring contracts and invoicing for all clinical trials conducted within the Clinical Research Department

BOC PRESENTATION

> 245 employees

The Clinical Operations Office oversees the operational implementation of all therapeutic trials and clinical studies, both academic and industry-sponsored, conducted at Gustave Roussy. The office's role is to coordinate projetcs as the Gustave Roussy Investigative center with differents participants, under the study's principal investigator's responsability and with compliance with rules and procedures in place In 2023, the office was managing over 50 open for inclusions studies and over 5660 new patients in clinical studies. It gave the office a leardership role and is a huge factor in the actractivenness of France in terms of clinical research

Certified Clinical Research Site :

Certified Clinical Research Site in 2011 by the Health Ministry, the office includes over 240 employees (CRA, CRN, MRA, SM etc.)

Goals and Tasks of the BOC

• Ensuring optimal care for patients participating in clinical and translational research projects across all departments and committees at Gustave Roussy
• Implementing operational procedures aligned with integrative research of high societal impact, stemming from continuous interaction with experimental research
• Managing the operational execution of research projects within study programs driven by advances in science and technology (new designs, Artificial Intelligence, etc.)
• Leading performance while strengthening the institution’s role as a preferred platform for hosting innovative industry-sponsored trials
• Delivering a high level of quality through Quality Management, ISO 9001 certification, and the adoption of continuous improvement principles by the teams
• Anticipating and managing increased activity by allocating the necessary clinical research and material resources.

BBE PRESENTATION

40 employees

The Biostatistics and Epidemiology Office (BBE) is made up of statisticians, statistician MDs, Public Health Interns, Data-managers, Health economists, Computer Engineers, Data-manager assistants and an Executive Assistant.

Missions

• Methodology ;
• Data-management ;
• Meta-analysis ;
• Cancer epidemiology ;
• Studies and research in Health economics

Teaching

• 700 hours of teaching per year ;
• Interships for Master's students in biostatistics, health economics and data-management ;
• Doctoral and post-doctoral training.

Labelling within the Oncostat team of the Epidemiology and Public Health Research Center (CESP) - INSERM UMR 1018 recognised for methodological aspects in all these areas..

Designated as Data Handling Center by INCa (French National Cancer Institute) in 2007

> 100

> 100

active for inclusion biomedical researches

publications per year

BQ/UFPV PRESENTATION

11 employees

• The Quality Office (BQ) is responsible for supporting clinical research stakeholders and providing them with the essential tools to ensure the proper conduct of clinical trials, with patient protection as a guiding principle.
• Representing the quality activities of the Clinical Research Department, its role is to facilitate the implementation of projects and enable their valorization.
• Through a continuous improvement approach to daily activities, the Quality Office contributes to Gustave Roussy's ambition to become a key player in clinical oncology research at both national and international levels.
• The Quality Office includes the Functional Pharmacovigilance Unit (UFPV), which manages pharmacovigilance for all trials sponsored by Gustave Roussy and develops a research program in pharmacovigilance.

QUALITY MISSIONS

Ensuring the preparation, management and coordination of Audits and Inspections and the elaboration of a post audit report

Ensuring Regulatory monitoring for the Good Clinical Practices (GCPs), broadcasting of informations and implementation of the regulations

Ensuring the education on GCPs for the DRC teams and health professionnals

Representing and being the Quality spokesperson for the DRC to the Quality Department

Ensuring the homogenization of the processes and the propagation of the rules and procedures

Ensuring the organization of the ISO9001 certification of the DRC

PHARMACOVIGILANCE MISSIONS

The Functional Pharmacovigilance Unit (UFPV) continuously assesses the safety profile of investigational treatments used in nearly 90 clinical studies sponsored by Gustave Roussy or other academic sponsors, particularly those based in the Île-de-France region on behalf of the GIRCI. The monitoring of investigational health products is subject to close scrutiny, especially regarding potential adverse effects observed in patients. The UFPV conducts these assessments in accordance with current French and European regulatory requirements, in order to ensure the safety of patients enrolled in phase I to III trials, both adults and children, involving chemotherapy, immunotherapy, radiotherapy, medical devices, gene or cell therapy, therapeutic strategy trials, diagnostics, surgery, and/or intensive care.Staffed by physicians and pharmacists, the unit operates a web portal for electronic reporting of serious adverse events (my eclinical) and uses a dedicated software platform (EveReport), which is interfaced with the European Medicines Agency’s (EMA) pharmacovigilance database, EudraVigilance.

The Unit actively contributes to the development of clinical research in France through its involvement in the activities of the Coordination of Institutional Sponsors (CPI) and the Pharmacovigilance Working Group (REVISE) of the National Assembly of Clinical Research Departments (DRCI).

Finally, the Unit is developing a research program in pharmacovigilance and pharmacoepidemiology, which notably includes the SACHA, EDHITO, REISAMIC, and PREMIS projects.

BVPPRESENTATION

The Valorization and Partnerships Office supports the dissemination of data, optimizes the use of clinical and biological data, and promotes synergy with translational research

Industrial Partnership Project Managers

5. Industrial Partnerships

Collaborations and partnerships with industry are a key priority for Gustave Roussy and, in particular, for the Clinical Research Department (DRC). These industry partnerships are developed in coordination with all of the Institution’s Multidisciplinary Committees and Departments, including the Department of Therapeutic Innovation and Early Trials (DITEP) :

• Through a proactive institutional policy aimed at enhancing attractiveness ;
• In the fields of innovative therapies (pharmaceuticals, biotechs), diagnostics, medical devices, and imaging ;
• Within the framework of clinical, preclinical, and translational studies ;
• By promoting the medical and scientific expertise of our teams, our operational capabilities, and our clinical and biological resources.

Objectives

To gain early access to the most innovative and beneficial compounds for our patients (both adults and children)

To validate their mechanism(s) of action or predictive biomarkers of efficacy or tolerance through ancillary studies

Finally, to benefit from essential complementary external resources to ensure the sustainability of the teams involved and the development of new approaches

To generate new hypotheses for future, value-generating research (publications, patents/licenses) and for academic-sponsored studies (Gustave Roussy, Unicancer)

QMS : gENERALITIES

1. Quality : roles and responsabilities

2. Field of application of the QMS

3. Clients of the DRC

4. Interested parties of the DRC

5. Expertise

1. Quality : Roles and responsabilities

The Quality System of the DRC interacts with Gustave Roussy's Quality System The roles of the system are divided as such :

AT GR LEVEL : The Quality, Risk Management and Patient relations Department ensures consistency between the clinical research quality system and the Gustave Roussy quality system AT THE CLINICAL RESEARCH LEVEL : The DRC Quality point of contact (Delphine Vuillier- Le Goff) ensures the operational link between the GR quality unit and the Clinical research (animation, process management, risk-based approach, document management, communication, awareness-raising and continuous improvement) The Quality Officers and Process Leaders in clinical research carry-out quality-related tasks within the offices and manage their processes in compliance with the clinical research quality policy

2. Field of application of the QMS

The QMS is established for the following activities :

To design, implement, analyse and valorize the Clinical Research studies (sponsorship)

To study the feasability of trials, select and implement trials, include and participate in the patient's follow-up (investigation)

To valorize the Clinical Research (sponsorship and investigation)

3. The clients of the DRC

Investigators Committees

Sponsors

Sponsorship

Investigation

For the activity :

For the activity :

To investigate the feasability of trials, select and implement trials, enrol and monitor patients, constantly develop, archive and close trials

To design, implement, analyse and constantly develop clinical research trials

4. The interested parties of the DRC

Establishment management

Patients

- Valorization of the establishment ; - Financial aspects ; - Quality of Clinical Research ; - Compliance with the establishment's project.

-Capacity to bring inovation to patients providing innovative, quality clinical research ; - Accessibility of information ; - Clinical Research ethics.

Competent authorities

Financial bodies

- Compliance with timescale and costs ;- Project implementation.

- Regulatory compliance ; - Patient benefits and safety.

InvestigatorCenters

Clinical research employees

- Equipment and logistics ;- Resources (human & financial) ; - Medical and operational support.

- Working in a stimulating environment; - Recognition from management (NAO).

ScientificalCommunity

Support functions / Interfaces

The support and operational functions have interface contracts with the designation of expectations.

Active participation in the international scientific activities

5. Expertise

The Clinical Research collaborators' expertise are defined in forms for the definition of functions

Actions are undertaken to develop staff skills, notably through training sessions and participation in information days and seminars.

A training plan is established annually in collaboration with the Training service of the Human Resources Department (HRD). In addition, staff members complete training modules available on Gustave Roussy’s educational platform: Gustave Roussy Education.

The effectiveness of the actions taken to develop skills is assessed during the Annual Performance Reviews (EAE).

QUALITY POLICY OF The DRc

1. Purpose and strategic orientation

2. Context and stake

3. Main focus

4. Goals related to quality

1. Purpose and strategic orientation

1. To deliver innovation to patients through high-quality, innovative clinical research ;2. To strengthen the integration of research into patient care and reinforce the bidirectional continuum between clinical, translational, and fundamental research ; 3. To embed the development of clinical research within a strategic, institutionally driven, integrative, and international framework.

The mediums

• Strengthen the sponsorship of clinical trials by Gustave Roussy, including “practice-changing” trials, as well as strategic academic partnerships with Unicancer and European research groups ;
• Implement an active policy of preferred partnerships with industry (Big Pharma and Biotech) within the framework of the Paris-Saclay Cancer Campus (PSCC) ;
• Implement continuous quality improvement, particularly in response to evolving regulatory requirements ;
• Establish a network of partner centers for the deployment of precision medicine (PRISM) and pragmatic trials.

The sectors

• Promote early drug evaluation, precision medicine, and immunotherapy by integrating new trial designs, methodologies, and decision-making algorithms ;
• Develop and validate new technologies (such as interventional radiology and radiotherapy) for loco-regional therapies, combined with systemic treatments when necessary ;
• Assess the psychosocial and medico-economic impact of innovation, ensure long-term follow-up, and incorporate risk-based approaches into early diagnosis and prevention ;
• Place a strategic focus on rare cancers in both adults and children, including rare subtypes of common cancers defined by specific biomarkers.

2. Context and stake

The clinical research stakes are defined in specific context relying on :

• The acceleration of the development of the therapeutic innovation in oconlogy and the expansion of the field of possibilities ;
• The following programs : IHU, PSCC, Cancer Core Europe.

1. Regulatory changes impacting clinical research, 2. Evolving funding and organization of public clinical research in France (a threat) ; 3. International competition.

Externalstakes

1. The institution’s capacity to implement its strategic vision (Institutional Strategic Project (PSI), Medical-Scientific Programs (PMS), emerging programs, routine research) in light of its ambitions and the potential scope of clinical research and innovation ; 2. The management, organization, and use of Big Data within a framework of data sharing and collaboration with external partners ; 3. The implementation of a structured and effective governance of priorities and resources, particularly through the organization of the Clinical Research Platform (+4).

Internal stakes

3. The main focus of the Quality Management System

To guarantee the satisfaction of our clients and relevant interested parties, the patients, first and foremost .

To maintain the quality management system (QMS) in accordance with standard ISO 9001

To guarantee the quality of our processes by allowing clinical research stakeholders to adopt and comply with operating regulations using a shared and accessible clinical trial management tool.

4. 2025-2027 Goals

To take into consideration the main improvement focus for our clients and interested parties to drive clinical research more effectively as part of the hospital care package

To maintain the 2025-2027 certification (new cycle)

To pursue the deployment of CTMS.

The engagements of management :

QMSMANAGEMENT

1. An organization by process

2. The steering of the processes

3. Managing the processes

4. Various committees and bodies

5. Documented informations

6. Continous improvement

7. Listening to clients and patients

1. An organization by process

Clinical Research has organised its management system into 3 areas of activities which take the strategic directions into account. Each area is described individually in the Clinical Research Quality Management Manual and outlines processes and procedures :

03

02

01

Designing and implementing Clinical Research projects

Steering the Clinical Research

Managing interfaces

4 realization processes

2 Management processes

12 interface agreements

The process comprises the methodical identification of the Clinical Research Department processes and the interactions between these various processes. A function overview is mapped out below :

2. The steering of the processes

A supervisor/guide is assigned to every process. His/her role is to manage and optimise the process lifespan. The aim of the supervisor/ guide is to initiate an approach that continuously improves the process. These missions are driven by two actions : “Defining” and “Steering and Improving”

• Identify and update the main process activities ;
• Identify, prioritise and define actions to reduce process-related risks ;
• Generate and update process documentation (creation, amendment, deletion).

Define

• Define and track monitoring methods (indicators) ;
• Ensure that the process is consistent with other processes and/or interfaces ;
• Check that the process works and is effective ;
• Ensure that the processses deliver the desired outcome ;
• Provide periodical progress reports ;
• Improve the way in which the process(es) work.

Steer and Improve

Process data sheets can be used to log all of the information relating to how each process operates. These process data sheets are reviewed and updated at least every year to produce an effective standard working document .

The interfaces interact with the processes. Those interactions are described in interface contracts. Their implementation with functional and operational back-up from the centre is checked periodically.

3. Managing the processes

Optimal steering of the processes is based on 4 main strategies each of which is linked to implementation of the control methods

Control methods

Main strategies

Process datasheet

Identification of risks and opportunities

Each process is identified

Selection of risks and opportunities

Study ofrisks

Selection of risks and opportunities depending on their significance in terms of impact (severity) and frequency.

Determination of actions

Quality improvement plan

The action to be taken in the light of risks and opportunities is documented

Evaluate the efficacy of the action taken

Department review

Evaluation of the efficacy of the action taken in the light of risks and opportunities during the Department review

Process monitoring is based on the indicators specified for each process and is tracked periodically. The process performance indicators are reviewed during the Department review. The latter also provides an opportunity to check whether the QMS is working effectively .

Process reviews assess how effectively the process is working. They can be used to highlight opportunities for improvement. The findings of the process review are presented during the Department review.

Internal audits are carried out to ensure that the QMS meets the requirements of standards ISO 9001 and that it is implemented effectively and updated. The audit findings are presented during the Department Review.

Interface reviews are used to assess how effectively the interface is working. They can be used to highlight opportunities for improvment. The findings of the interfaces review are presented during the Department review.

The Department review ensures the efficacy of the QMS.

4. Various committees and bodies

Its mission is to analyze and select study promotion requests submitted by physicians and researchers at Gustave Roussy, as early as possible in their development, based on a synopsis and an initial cost estimate. Project sponsors are invited to present and discuss their proposals. The Promotion Intake grants Gustave Roussy’s agreement to sponsor the study.

Sponsor Reception

Composition

The Scientific Committee for Therapeutic Trials (CSET) has an advisory role and is tasked with assessing the scientific and ethical relevance of clinical research studies. In particular, the CSET ensures:

CSET

• The absence of redundancy of trials within the same pathologies (based on the main inclusion criteria) and within the decision-making trees of the Committees, Departments, and cross-departmental Units ;
• The scientific and methodological quality of therapeutic trials ;
• Compliance with the applicable legislative and regulatory requirements.

Composition

Applications are submitted and reviewed on a rolling basis.

The role of the Operational Research Studies Committee (COMOP) is to ensure the proper operational implementation of clinical research projects, based in particular on the feasibility questionnaire completed by the sponsors or their delegates, the information provided during the selection visit, exchanges with the CRO appointed by the sponsor, and agreements obtained from the various concerned GR partner departments. The study’s lead CRA (accompanied by the CRA Manager) or, where applicable, the Multicommittee Trial Project Manager, presents the study to the COMOP after ensuring that the study’s processes and associated documents are properly organized. Only after obtaining approval from both the CSET and COMOP does the Director of Clinical Research give DRC authorization for the study to be initiated once the agreement is signed..

COMOP

Composition

5. Documented information

The documentation system is structured like a pyramid. The various types of document are generated such that they highlight each level at which they are involved in the quality management system : The Clinical Research procedures (PO) and work instructions (MO) are checked against the management regulations defined at establishment level.

Quality Policy

Quality Manual

Procedures

Work Instructions (MO)

Process description

Form and record form

Electronic Data Management (EDM), with BlueKanGo, is used to monitor the document validation and circulation cycle .

Legal monitoring is used within CR and is linked to the Legal Department via the mutual monitoring service developed by UNICANCER. This monitoring is supplemented by :

• Participation in the PV REVISE working party and CPI group ;
• Regulatory monitoring by the pharmya CRO (PV) ;
• ANSM monitoring (via ANSM) ;
• GIRCI monitoring ;
• Monitoring in accordance with ISO 9001 standards (via AFNOR).

6. Continous improvement

The handling of adverse events is carried out during Risk Operational Meetings, organized by the Quality, Risk Management, and Patient Relations Department

Measurement and monitoring are performed through dashboards (quality improvement plan) and the indicator table.

Quarterly DRC quality meetings are held to define actions and assess their effectiveness in addressing major non-conformities.

Customer satisfaction is measured and monitored following the planned communication actions.

7. Listening to clients and patients

Listening to clients is one of the cornerstones of a company’s quality management system. Knowing how to identify and maintain current and future requirements are the targets of an optimally executed client monitoring strategy. Listening to clients is a dynamic approach. The requirements of Clinical Research clients can be met by anticipating their requirements and by measuring and monitoring their satisfaction. The listening to clients’ campaign or test procedure is carried out annually and/or according to requirements. The following tools are used :

Listening to clients

• Study claims
• Newletters
• Questionnaires
• Committee meetings
• Website, etc.

All patient complaints are monitored by the Gustave Roussy Mediator and Legal Officer .Complaints lodged by patients taking part in a trial are identified (from the medical records) and any potential link with clinical trial participation . The annual report listing patients’ complaints probably or possibly linked to clinical trial participation is analysed during the Department review . Any necessary action is discussed and implemented .

Patients participating in trials

Several strategies including the opinion of several patient committees are developed in order to focus on and meet the requirements of patients taking part in clinical trials sponsored by Gustave Roussy . These include :

Patient's Committee

• Opinion of the Patients' League Committee on protocols and information leaflets relating to each trial ;
• Opinion of UNAPECLE for paediatric trials ;
• Participation of the Patients and Caregivers Committee in certain DRC working groups.

GLOSSARY

Glossary

ANSM : French National Agency for the Safety of Medicines and Health Care Products AMR : MRA - Medical Research Assistant ARC : CRA - Clinical Research Assistant BBE : Biostatistics and Epidemiology Office BOC : Clinical Operations Office BPC / GCP: Bonnes Pratiques Cliniques / Good Clinical Practices BPP : Projects and Sponsorship Office BQ : Quality Office CA : Competent Authority CDA : Confidentiality Agreement CEC : Clinical studies coordinator CESP : Epidemiology and Public Health Research Center CLCC : Anti-Cancer Center COMOP : Operational Research Studies Committee CP : PM- Project Manager CPI : Coordination of Institutional Sponsors CPP : EC - Ethics Committee CRO : Contract Research Organization CSET : Scientific Committee for Therapeutic Trials CTMS : Clinical Trials Management System DIST : Investments Management and Technical Services DITEP : Department of Therapeutic Innovation and Early Trials DRC : Clinical Research Division DRCI :Innovation and Clinical Research Delegation DTNSI : Digital Transformation and Information Systems Department EIG : Severe Adverse Effects GED : EDM - Electronic Data Management GIRCI : Inter-Regional Clinical Research and Innovation Group GR : Gustave Roussy GRE : Gustave Roussy Education GRT : Gustave Roussy Transfert GP : SM - Samples Manager IHU : University-Hospital Institute IF : Impact Factor IRC : CRN - Clinical Research Nurse MAQ : QMA - Quality Management Manual PHRC : Hospital Clinical Research Program PM : Project Manager PMS : Medical Scientific Programs PSCC : Paris-Saclay Cancer Campus PSI : Institutional Strategic Project PV : Pharmacovigilance RC : Clinical Research RIPH : Human Subject Research RGPD : General Data Protection Regulation RWD : Real World Data SMQ : QMS - Quality Management System TRC : Clinical Research Technician UFPV : Functional Pharmacovigilance Unit UNAPECLE : National Union of Associations of Parents of Children with Cancer or Leukemia

CONTACT

Direction de la Recherche Clinique

114 rue Edouard Vaillant 94800 Villejuif

01 42 11 42 11

CTquality@gustaveroussy.fr

Departments

Biology and pathology

Cécile Badoual

Pediatric and adolescent oncology

Christelle Dufour

Department of Anesthesia, Surgery and Interventional Procedures

Maximiliano Gelli

Interdisciplinary Department for Patient Pathway Organization

Florian Scotté Inès Vaz Duarte Luis, adjointe

Department of Therapeutic Innovation and Early Clinical Trials

Christophe Massard Yohann Loriot, adjoint

Hematology

Stéphane de Botton

Medical Imaging

Corinne Balleyguier

International

Axel Le Cesne

Medical Oncology

Laurence Albigès Alexandra Leary, adjointe

Radiation Oncology

Eric Deutsch

Pharmacy

Bernard DO

Sénologie

Barbara Pistilli

Tumeurs endocrines

Eric Baudin

Composition of the Promotion Unit :

• Director of Clinical Research or Representative from the Projects and Promotion Office ;
• Statistician ;
• Health Economist ;
• Head of Promotion ;
• Clinical Research Manager - Promotion Unit ;
• Regulatory Affairs Manager.

CSET composition

• President ;
• Tenured member ;
• Alternate member, per committee.

COMOP composition

• Head of BOC ;
• Operational Project Manager (responsible for the coordination and follow-up of the COMOP) ;
• Clinical Research Coordinator BIOPATH ;
• Imaging Coordination CRA ;
• Members from other partner offices or departments :
• Representatives from DRC/CRB
• Referent Pharmacist for late-phase or early-phase trials, depending on the type of study ;
• Representatives from the Day Hospital (HDJ) and/or Inpatient Units;
• Representatives from the Projects and Promotion Office (BPP), namely the Contracts Manager ;
• Single Window Project Manager ;
• Partnerships Project Manager.

Committees

Oncogenetics

Olivier Caron

Head and neck

Ingrid Breuskin

Dermatology

Caroline Robert

Gastrointestinal

Michel Ducreux

Gynecology

Patricia Pautier

Hematology

Stéphane de Botton

Neurology

Frédéric Dhermain

Pediatric and adolescent oncology

Véronique Minard-Colin

Thoracic

David Planchard

Genitourinary

Karim Fizazi

Sarcoma

Matthieu Faron

Breast oncology

Barbara Pistilli

Endocrine tumors

Eric Baudin