ICORG Central Office Newest Members!

Kay Duggan-Walls joined ICORG in December 2007 as Group Development Executive. Kay’s role is to assist the chair and vice-chair in developing a cohesive Group Structure. Kay is based in the Group Central Office and will work with the SDMO, GCO and hospital sites to enhance communication and to promote a cohesion in all Group activites across sites. Another responsibility of the post is the administration development of the Disease Specific Subgroups.

Kay can be contacted at .(JavaScript must be enabled to view this email address)

Finally Helen Matthews (missing from above photo) joined ICORG in February 2008 as a Clinical Project Manaher. Helen will work predominantly on Radiotherapy studies at St Luke’s Hospital, Rathgar and will coordinate ICH-GCP training at ICORG.

For more information on the ICORG group structure click here

Technical Resources Guide

Further to ICORG Translational Subgroup Meeting on the 21st September 2007, please find below the current draft of the Technical Resources Guide. The purpose of this document is to provide a detailed breakdown of the various technological resources available within Ireland that can be harnessed for translational research projects in cancer. Emphasis is placed here on specialised techniques and expertise at different institutions. It should be clear that this is not an exhaustive list of facilities available around the country, but merely a guide. We have mapped out the key contact points at each institute for each technology/facility.

Statement by the Minister for Health & Children Mary Harney, T.D. on Cancer Research

Commenting on the publication today of the European Cancer Research Managers Forum Second European Survey the Minister for Health and Children, Mary Harney T.D. said: “This report analyses how cancer research is funded and enables us to monitor our progress in cancer research funding in relation to our European counterparts.”

New cancer specialist centres named

A new plan, announce by the Health Service Executive, sees eight hospitals in Dublin, Cork, Limerick, Waterford and Galway becoming the major specialist cancer centres.

But it also involves the immediate closure of cancer services at 13 other hospitals around the country.

Re-launch of ICORG website

ICORG are pleased to announce the re-launch of the company’s website (http://www.icorg.ie)

In addition to the existing sections, the updated website includes a patient focused area with information on current clinical trials available in Ireland. The members’ area now includes information relating to all Disease Specific SubGroups, which allows members to view meeting dates, current group members and minutes of previous meetings. Members will also be able to view an extensive list of all ICORG studies, from which protocols and Patient Information Leaflets may be downloaded directly.

There will be an introduction to the new ICORG website at the Scientific and Educations meeting on the 21st September in the Fitzwilliam Hotel.

Dublin, 09 July 2007

The Irish Pharmaceutical Healthcare Association (IPHA) welcomes the introduction of a standard HSE Clinical Trial Indemnity Form (HSE CTIF) for the conduct of clinical trials in Ireland. This will facilitate the effective and timely initiation of clinical trials and remove administrative barriers created by individual trial centres reviewing the same indemnity agreement for each and every single trial.

CIS Confirms Cover For All ICORG International Investigator Led Studies

The State Claims Agency have confirmed to all hospitals that CIS cover will extend to cover Investigators and Hospital enterprises from claims arising from design or protocol in relation to all ICORG conducted trials, where ICORG is listed as sponsor. ICORG would like to extend its’ gratitude to the State Claims Agency for its’ ongoing, prompt and apt support.

Pharmacovigilance

ICORG are pleased to announce the development of our dedicated Pharmacovigilance Unit as of May 1st 2007. At a time when drug safety concerns have become increasingly important in public health and modern clinical practice, the Pharmacovigilance Unit is designed to evaluate the ongoing safety of investigational drugs and also provide notification to all concerned members of any findings that could adversely affect the health of patients enrolled on ICORG studies. This is performed in accordance with the EU Directive 2001/20/EC and ICH-GCP guidelines and will continue to develop in response to the special needs of members.

Clarification of EU Directive on Clinical Trials

The definition and responsibilities of sponsor are given in Article 2 of Directive 2001/20/EC

(e) ‘sponsor’: an individual, company, institution or organization which takes responsibility for the initiation, management and/or financing of a clinical trial;

How should this definition be interpreted?