Group Structure
ICORG has two offices, the Group Central Office (GCO) and the Statistics & Data Management Office (SDMO). In terms of physical location, the Statistics & Data Management Office (SDMO) is based in Belfast, while Group Central Office (GCO) performs a project management, coordinating and administrative role from Dublin.
The ultimate responsibility for group decisions lies with the ICORG executive. The executive makes decisions regarding group direction, financial issues and scientific direction based on the advice and recommendations of the executive management group, the finance committee, the disease specific sub-groups and the external advisory group. Executive decisions are passed on to the Group Central Office (GCO) and the Statistics and Data Management Office (SDMO) who then implement these decisions through their functions with the membership and the sites.
ICORG Organisational Structure:
Executive Group Chair:
The role of the Chair is to lead the debate at Executive meetings and work with the GCO CEO, Group Develpment Executive and SDMO Director to action executive decisions. This position is rotated every 4 years and is filled by the previous Executive group vice chair. The election process for position of vice chair is as follows – any group member may be nominated and seconded by any other group member. All nominees go before the ICORG executive and a secret ballot takes place to elect the incoming vice chair. This vice chair takes this position for 4 years and assumes the Chair at the next time of rotation.
For more information on the constitution: click
here , for more information on the Executive: click
here
The ICORG Executive Management Group
The executive management group is a sub-set of the ICORG Executive who meets on a more frequent basis than the executive to review the progress of key strategic and operations projects. This committee meets 8 to 10 times per year and consists of the group chair, vice chair, medical modality leader, ex-group chair, group statistician, GCO CEO, Group Develpment Executive and SDMO director.
The ICORG Finance Committee:
The financial decisions of the Executive are informed by the Finance Committee which is a sub committee of the Executive appointed by the group chair. The Finance Committee is currently chaired by the previous executive group chair. The remainder of the committee is made up of two external financial experts, the GCO CEO and a member of the Irish Cancer Society management team, with administrative support provided by the ICORG GCO office manager.
The ICORG Disease Specific Sub-Groups
The DSSG’s meet approximately every 2 months. They consist of all ICORG members with an interest in that disease area. The chair of each DSSG is elected by its membership and has a period of tenure of 4 years. The group’s policy on the operation of the DSSG’s is that all member ideas get included on the meeting agenda.
Functionally, the DSSG chairs frequently delegate subsections of DSSG activity to other members of the group. All functions of the DSSG’s are managed by the GCO. The group statistician is also in attendance at each meeting.
For more information on ICORG DSSG : click
here
(Please note that this information is for member's only and requires a password)
The ICORG Scientific External Advisory Committee
ICORG has established an external advisory committee, which regularly reviews the groups’ organisation and structures, trial portfolio, research profile and trial activity. Its role is to analyse these criteria in the context of international best practice and advise how they are likely to evolve in the future in keeping with international trends. They also rank all group protocols for scientific merit, suitability for the group and priority for the future.
This committee currently consists of:
- Mr. Walter C. Cronin: Associate Director for Operations, NSABP Biostatistical Centre, Pittsburg, USA
- Dr. Peter O’Dwyer, MD:Director of Developmental-Therapeutics Program, Abramson Cancer Center, Director of Haematology – Oncology, Penn Presbyterian Medical Center, Philadelphia, USA
- Prof Richard Sullivan: Department of Social Policy (Health, Population & Society),London School of Economics & Political Science. UK (& Chairman, European Cancer Research Managers Forum: www.ecrmforum.org).
- Dr. Eileen O’Reilly: Consultant Medical Oncologist, Gastrointestinal Oncology Service, Memorial Sloan-Kettering Cancer Center, New York, USA
- Prof Robert Leonard: Director of Cancer Services,Charing Cross Hospital, London, UK
The committee reports via ICORG’s formal structures, and is fully operational providing regular feed back to the group.
Group Central Office:
The Group Central Office (GCO) based in Dublin, has a role in project management, pharmcovigilance, on-site monitoring, group meetings and international collaborations. Since its inception, GCO has managed and monitored the accrual of more than 2500 patients to more than 52 high quality studies. There is a good deal experience and knowledge amongst current GCO staff with more then 50 combined years of experience in the management and monitoring of clinical trials, much of it gained in pharmaceutical industry registration standard studies. In recent years, GCO has participated in a number of investigational new drug level studies and has succeeded in producing high quality data matching the standards of international collaborators.
GCO Staff
GCO
currently has a staff of 21, comprising, 1 Chief Executive
Officer, 1 Group Development Executive, 3 Project Managers, 6 Clinical
Research Associates, 3 Trainee Clinical Research Associate, 1 Quality Manager ,
2 Clinical Trial Administrators, 1 Pharmcovigilance Consultant, 1 Pharmcovigilance Associate, 1 Senior
Administrative Assistant and 1 Financial Controller (PT).
The
Group Development Executive is based in the GCO and reports to the Group Chair,
and is responsible for promoting cohesion and enhancing communication in all
Group activities across sites.
There is a team based approach to ongoing projects which means that the project management group also contribute to the on site data monitoring function. The GCO has a number of projects in the advanced stages of development and anticipates adding to its resource in the coming months.
GCO Functions
GCO has responsibility for the all operational aspects of ICORG activities, facilitating the 16 hospital sites throughout the country in all aspects of the ICORG clinical research programme. This includes many of the elements associated with the design, development and conduct of clinical studies. GCO also manages new relationship development and is thereby responsible for sourcing new studies. A continuous dialogue takes place between GCO and the Team Leaders based at each site, such that the Team Leaders function as a critical link in the greater ICORG network.
GCO also co-ordinates the activities of the Disease Specific Sub-Groups (DSSG’s) through which the Scientific Development of ICORG is formulated. GCO provides local expertise in regulatory and ethics processes in Ireland, the UK and Europe. It is Eudravigilance accredited by the European Agency for the Evaluation of Medicinal Products (EMEA), allowing direct access by GCO employees to the European safety database.
GCO has experience in drug distribution, accountability and labelling, which has facilitated the movement of drugs from the US for NSABP C-08 and other activities.
Finally, GCO manages and coordinates many elements of the clinical trial process.
Statistics and Data Management Office (SDMO):
The SDMO aims to provide an independent, scientifically sound statistical and data management function for the Group. These functions are co-ordinated through the Northern Ireland Clinical Research Support Centre (CRSC) located on the Royal Victoria Hospital site in Belfast www.crsc.n-i.nhs.uk
The SDMO provides the statistics, health economics and data management functions for the Group and is responsible for all quantitative aspects of ICORG trial activities, as per our funding agreement and the recommendation of the funders’ international review panel.
This role includes supporting and informing the design and conduct of in-house trial protocols; review of other protocols being considered for the Group portfolio; providing the statistics, health economics and data management functions for all in-house protocols and for any other protocol as negotiated (e.g. design, subject registration / randomisation, data collection, query management, analysis).
The Belfast office is also responsible for coordinating IT development in support of clinical trials, and for monitoring aspects of performance such as accrual. Members of the SDMO team also contribute to the development of Group strategy; and development and participation in Group training programmes.
In addition, two representatives of the SDMO (the Director of CRSC and the senior statistician who executes the role of Group Statistician) have executive responsibilities, contributing to the oversight, high level decision making processes and strategic direction of ICORG.
Staff
Since in its inception in 2002, the Clinical Research Support Centre (CRSC) has evolved as a broadly based, multidisciplinary team which provides support across a wide range of clinical research. The CRSC staff includes a medical statistics, health economics, epidemiology, clinical data management, regulatory requirements and the management of intellectual property related to research.
All staff members are trained in the conduct of research to Good Clinical Practice (GCP) standards. All study development and conduct procedures are documented and followed, as per CRSC standard operating procedures. The latter are reviewed and updated with appropriate version control according to office policy.
Key People in the Belfast Office
The Group Statistician (Mike Parker): this role involves responsibility for the operation of the statistical services for the Group, for the scientific direction of the statisticians working with the Group, and for the integrity of all data files and statistical analyses.
Data Project Manger (Vacant): this role involves responsibility for the computerisation and quality control of all data received at the SDMO, the design and implementation of the ICORG data processing system, and all software design and implementation for the Group. The senior data coordinator is also responsible for liaison with the Group Central Office in the development of ICORG protocols and related forms.
The IT specialist: responsible for the design and maintenance of IT systems for data handling and communications
The Data specialists: Individuals at the SDMO who are responsible for quality control, assessment and computerisation of data submitted by participating Institutions. This generic term includes the senior coordinating position and data entry operators.
