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.
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.
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.
Medicine Weekly 11 February 2004