Training

Welcome to the training section of the ICORG website.

According to Good Clinical Practice (GCP) Principle 2.1 Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s); 2.8 Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s); and Investigator Responsibility 4.1.3 The investigator should be aware of, and should comply with, GCP and the applicable regulatory requirements.
According to Regulation 24 of the Regulations for Clinical Trials on Medicinal Products for Human Use (SI 190 of 2004) a person shall not conduct a clinical trial otherwise than in accordance with the conditions and principles of good clinical practice.
It therefore follows that each person involved in a clinical trial should receive training in Good Clinical Practice commensurate with their roles and responsibilities. The training should be given at intervals appropriate to ensure staff maintains current awareness of the Irish Regulations and applicable European guidelines. Appropriate updates should be provided when applicable procedures, guidance or legislation change.
ICORG recommends that all research staff who work exclusively in research e.g. research nurses and data managers attend ICORG’s two day programme (GCP Day 1 and Day 2) within 6 months of starting their positions.
In addition ICORG mandates that all research staff attend GCP training at a minimum every 2 years. This includes research nurses, data managers, investigators/ sub-investigators, research registrars, radiation therapists and research pharmacists. For this purpose we run a refresher GCP course at the ICORG scientific meetings held four times each year.
If you have any queries regarding your training requirements please do not hesitate to contact the ICORG office on +353 (0)1 6677211 or info@icorg.ie.