Training & Conferences

Course Overview

RCSI CLINICAL RESEARCH CENTRE: EDUCATION AND TRAINING

A one day course aimed at investigators, project managers, research nurses and other research team members involved in the conduct of medical device research at a clinical research site.  It is also relevant to sponsors and device manufacturers involved in initiating clinical investigations.  This course incorporates the requirements of the Medical Device Regulations and ISO 14155 (2020), and includes the following content:

• Overview of Clinical Research
• Principles of Good Clinical Practice
• Medical Devices (What is a Medical Device; Types & Classification; Medical Device Legislation; Clinical Investigations)
• Good Clinical Practice in Device Trials (Ethical Issues; Conduct of a Clinical Investigation; Safety Reporting in Device Research)
• Monitoring & Audit

This course is accredited as a component of the Postgraduate Certificate in Clinical Research Practices, RCSI School of Postgraduate Studies (2 ECTS).

Due to disruption caused by the Covid-19 Pandemic we are now offering remote access to this course via MS Teams.

Date: Thursday 20^th August 2020  09.30 – 15.00

Cost: €60.00

Enquiries: Deirdre Hyland, Director of Research Nurse Education, RCSI CRC dhyland@rcsi.com

Course Overview

RCSI Clinical Research Centre

This online course explores elements of the clinical research coordinator role. It is aimed at research nurses and midwives, research assistants, project managers, data managers and others involved in the day to day conduct of a research project.

NOTE: The course is available online with ongoing access to the course immediately.

Topics included are:

• Role of study coordinator
• Study set-up – Budgets, feasibility, administration, site preparation
• Patient recruitment
• Patient study visit management
• IMP and resource management
• Documentation In clinical research
• Data management, safety reporting and discrepancy management
• Site file management
• Study close-out and archiving
• Preparing for Audit and Inspection

This course has been accredited as an optional component of a Postgraduate Certificate in Clinical Research Practices, School of Postgraduate Studies, RCSI (5 ECTS). It is also accredited by the Nursing & Midwifery Board of Ireland for 18 continuing education units (CEUs). The course costs €180 (external attendees).

For more information and for a booking form please contact:

Deirdre Hyland:(01) 809 3785   dhyland@rcsi.ie

Download the course booking form here.

GCP Full Course– HRB Clinical Research Facility Cork

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).

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 and HRB CRF-C Research Nurse: Jean Foley.

If you would like to reserve a place on the course or if you have any further queries please do not hesitate to contact  Lucy Deane

The 4 hour ICH GCP course will take place on the following dates:

The 2 hour 30 mins refresher ICH GCP course will take place on the following dates:

6th Trial Methodology Symposium – ONLINE – Improved trials for better health decisions for an informed public

Hosted by HRB-TMRN and HRB CRF Cork. Further details to follow shortly.

GCP Training/Refresher Course– HRB Clinical Research Facility Cork

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).

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 and HRB CRF-C Research Nurse: Jean Foley.

If you would like to reserve a place on the course or if you have any further queries please do not hesitate to contact  Lucy Deane

The 4 hour ICH GCP course will take place on the following dates:

The 2 hour 30 mins refresher ICH GCP refresher course will take place on the following dates:

HRB CRCI International Clinical Trials Day event is rescheduled to Friday 6th November 2020.

Further details and booking instructions will follow shortly and will be notified on our website and twitter feed.

Hosted by the Irish Health Research Forum.

This event has been rescheduled to Thursday 12th November 2020, 9.00 am to 1.00 pm, at The Wood Quay Venue, Dublin City Council Civic Offices, Dublin 8.

Check the IHRF website for further details and booking instruction.

GCP Full Course– HRB Clinical Research Facility Cork

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).

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 and HRB CRF-C Research Nurse: Jean Foley.

If you would like to reserve a place on the course or if you have any further queries please do not hesitate to contact  Lucy Deane

The 4 hour ICH GCP course will take place on the following dates:

The 2 hour 30 mins refresher ICH GCP course will take place on the following dates:

Trust and Truth in Health Research – Building trust in research evidence to support informed health decisions

The annual HRB Conference for 2020 will take place online on November 24/25

Full details of the conference programme at the HRB website.

GCP Training/Refresher Course– HRB Clinical Research Facility Cork

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).

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 and HRB CRF-C Research Nurse: Jean Foley.

If you would like to reserve a place on the course or if you have any further queries please do not hesitate to contact  Lucy Deane

The 4 hour ICH GCP course will take place on the following dates:

The 2 hour 30 mins refresher ICH GCP refresher course will take place on the following dates: