Welcome to the training section of the Cancer Trials Ireland website.
According to Good Clinical Practice (GCP) Principles 2.1 and 2.8 and Investigator Responsibility 4.1.3 respectively:
- 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);
- Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).
- The investigator should be aware of, and should comply with, GCP and the applicable regulatory requirements.
- Regulation 24 of the Regulations for Clinical Trials on Medicinal Products for Human Use (SI 190 of 2004) states that “a person shall not conduct a clinical trial otherwise than in accordance with the conditions and principles of good clinical practice”.
It follows that each person involved in a clinical trial should receive training in GCP commensurate with their roles and responsibilities and at appropriate intervals to ensure they maintain awareness of the current regulations and guidelines.
Introductory GCP training
Cancer Trials Ireland requires that all research staff who work exclusively in research, e.g. research nurses and data managers, attend Cancer Trials Ireland’s full day introductory GCP training course which we hold at least twice a year.
Refresher GCP training
In addition, Cancer Trials Ireland 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 Cancer Trials Ireland scientific meetings held three times each year.
Both the Introductory and Refresher GCP training meet the TransCelerate minimum criteria for GCP training of investigational site staff to enable mutual recognition of GCP training among clinical trial sponsors. A knowledge assessment is required to be completed by the attendees as part of the minimum criteria for these courses.
With thanks to ICON Clinical Research, Cancer Trials Ireland is now offering ICH GCP training via the ICON Firecrest online GCP portal to all investigational site staff working on our trials. The completion of the online training, including an assessment, fulfills Cancer Trials Ireland’s requirement for site staff to complete a 2-yearly GCP refresher course or as basic training for those starting work in clinical trials while they are waiting to attend the next ICH GCP training (full day course) at Cancer Trials Ireland. Further information on how to register for the online training portal is available in the Members Resource section of our website or please contact firstname.lastname@example.org.
New for 2017: All courses in 2017 include the updates to GCP issued as the GCP E6(R2) addendum in November 2016.
If you have any queries regarding your training requirements please do not hesitate to contact the Cancer Trial Ireland office on +353 (0)1 6677211 or email@example.com.