The Quality and Regulatory Department helps to ensure that patient focused research undertaken under the supervision of the HRB CRF is conducted to the highest standards. The HRB CRF-C operates in accordance with a fully regulatory compliant Quality Management System and provides the full suite of Quality and Regulatory services required to support world class patient focused research.
Our team of experienced clinical research professionals regularly deliver ICH-GCP Training to investigators and study site staff, both initial GCP training (4.5 hours) and refresher GCP course (2.5 hours).
Good Clinical Practice Course (Full Course)
The following content is included:
- Rules & Regulations governing Clinical Research
- Principles of Good Clinical Practice
- Investigator Responsibilities
This course meets the minimum criteria for ICH GCP Investigator site personnel training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors.
The course has category 1 Bord Altranais approval for Continuing Education Units (CEU). Physicians who attend are eligible for Continuing Professional Development (CPD) points from the Royal College of Physicians in Ireland (RCPI).
The course has been developed and will be delivered by HRB CRF-C Director of Quality and Regulatory Affairs:Dr Ruben Keane, HRB CRF-C Monitor: Máire McCarthy, HRB CRF-C Research Nurse: Jean Foley and HRB CRF-C Research Support Officer (Quality): Maria Spillane.
If you would like to reserve a place on the course or if you have any further queries please do not hesitate to contact Aoife Quinlan
The 4 hour ICH GCP course will take place on the following dates:
|18th September 2019||Afternoon session|
|12th November 2019||Morning session|
|21st January 2020||Afternoon session|
|12th March 2020||Morning session|
|13th May 2020||Afternoon session|
|14th July 2020||Morning session|
|16th September 2020||Morning session|
|17th November 2020||Afternoon session|
The 2 hour 30 mins refresher ICH GCP course will take place on the following dates:
|17th October 2019||Afternoon session|
|4th December 2019||Morning session|
|19th February 2020||Morning session|
|21st April 2020||Afternoon session|
|18th June 2020||Morning session|
|15th October 2020||Afternoon session|
|2nd December 2020||Afternoon session|