Training – GCP

Cancer Trials Ireland provides training in Good Clinical Practice (GCP). 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.

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.

Full Day Introductory GCP training course

This course is offered at regular intervals, and at least twice a year. Please contact us to find out the next available date.

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.

This course covers the following:

·      Introduction to ICH GCP

·      Principles of ICH GCP

·      Investigator Responsibilities

·      Sponsor Responsibilities

·      Essential Documents

 

This course is suitable for those starting work in clinical trials or serves as an in-depth refresher course for others with experience. The course is open to all members. Pre-reading of the GCP guideline is required before attendance and there are plenty of workshops to help participants learn ways in which to comply with the requirements.

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 DSSG meetings held face to face twice each year.

It provides an introduction to or a re-cap on the following:

·       Principles of ICH GCP

·       Investigator Responsibilities

·       Resources (Staff/ Patient Recruitment)

·       Training/ Delegation

·       Protocol Compliance

·       Informed Consent

·       Management of Investigational Product

·       Essential documents

·       Safety reporting

·       Knowledge Assessment

Both the Introductory and Refresher GCP training meet the TransCelerate minimum criteria for GCP training of investigator 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. For further information on how to register for the online training portal please contact info@cancertrials.ie.

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 info@cancertrials.ie.