Course Overview

A three day course designed to explore elements of the clinical research nurse/study coordinator role.

This course will be delivered over 3 days using a combination of face to face (2 days) and online (equivalent to 1 day) teaching strategies. 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

Day 1: Study Set-up (face to face)

Day 2: Managing Study Participant Visits (online)

Day 3: Safety and Regulatory Issues (face to face)

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).

NOTE: This is the final day of a 3-day course commencing on Feb 26th 2020

Cost (external attendees): €180.00

CRCM Day 1: Wednesday 26^th February, 09.00 – 16.30,

Tutorial Room 1, RCSI Education & Research Centre, Beaumont Hospital.

CRCM Day 2: Online date TBC.

CRCM Day 3: Monday 6^th April, 09.00 – 16.30,

Tutorial Room 2, RCSI Education & Research Centre, Beaumont Hospital.

Download the course booking form here.

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

NOTE: This symposium has been cancelled

The joint Cochrane Ireland and Cochrane UK symposium (supported by Evidence Synthesis Ireland) will be held on 21^st – 22^nd April 2020, at The Gibson Hotel, Point Square, Dublin.

Information and booking details for the symposium can be found on the Cochrane 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:

Course Overview

A three day course designed to explore elements of the clinical research nurse/study coordinator role.

This course will be delivered over 3 days using a combination of face to face (2 days) and online (equivalent to 1 day) teaching strategies. 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

Day 1: Study Set-up (face to face)

Day 2: Managing Study Participant Visits (online)

Day 3: Safety and Regulatory Issues (face to face)

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).

Cost (external attendees): €180.00

CRCM Day 1: Thursday 23rd April 2020, 09.00 – 16.30,

Tutorial Room 1, RCSI Education & Research Centre, Beaumont Hospital.

CRCM Day 2: Online date TBC.

CRCM Day 3: Thursday 18th June 2020, 09.00 – 16.30,

Tutorial Room 2, RCSI Education & Research Centre, Beaumont Hospital.

Download the course booking form here.

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

Save The Date – 6th May 2020

The HRB Primary Care CTNI and PPI Ignite at NUIG will host the 5th annual Public and Patient Involvement in Research conference at the Institute for Lifecourse and Society (ILAS), NUI Galway .

Further details to follow

This one day course is relevant to Principal Investigators, research nurses and associated research site personnel who have not undertaken GCP training within the previous 2 years. The following content is included:

• Introduction to Drug Development and Clinical Research
• Research Ethics and Clinical Research Governance
• Principles of Good Clinical Practice
• Investigator Responsibilities
• Regulatory Inspection

The course has Category 1 Approval from NMBI – 6.5 CEUs. It meets the minimum criteria for ICH GCP training identified by TransCelerate Biopharma as necessary to enable mutual recognition of Investigator Site GCP training by trial sponsors. It is also accredited as a component of the Postgraduate Certificate in Clinical Research Practices, RCSI School of Postgraduate Studies (2 ECTS)

Cost:  €100.00 (External attendees),  €30 (Student rate)

Download the course booking form here.

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

Wednesday 13^th May, Tutorial Room 2, RCSI Education & Research Centre, Beaumont Hosp.  

Hosted by the Irish Health Research Forum.

Save The Date : Weds 13th May 2020, 9.00 am to 1.00 pm, at The Wood Quay Venue, Dublin City Council Civic Offices, Dublin 8.

The meeting is not about the science of genomics but will focus instead on what Ireland needs to do to fulfil the promise of genomics for the benefit of the public.

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:

The HRB CRCI planned event to launch ICTD 2020 is postponed to Q4 2020.

Confirmed date and details will follow in due course.

Course Overview

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 conducting clinical investigations.  This course 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)

Cost External Attendees : € 60. Students – € 30

Download the course booking form here.

Registration: To reserve a place please contact course coordinator, Deirdre Hyland   01 8093785

Wednesday 10^th June

Tutorial Room 2,     RCSI Education & Research Centre, Smurfit Building, Beaumont Hospital

Course Overview

A three day course designed to explore elements of the clinical research nurse/study coordinator role.

This course will be delivered over 3 days using a combination of face to face (2 days) and online (equivalent to 1 day) teaching strategies. 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

Day 1: Study Set-up (face to face)

Day 2: Managing Study Participant Visits (online)

Day 3: Safety and Regulatory Issues (face to face)

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).

NOTE: This is the final day of a 3-day course commencing on April 23rd 2020

Cost (external attendees): €180.00

CRCM Day 1: Thursday 23rd Aptil 2020, 09.00 – 16.30,

Tutorial Room 1, RCSI Education & Research Centre, Beaumont Hospital.

CRCM Day 2: Online date TBC.

CRCM Day 3: Thursday 18th June 2020, 09.00 – 16.30,

Tutorial Room 2, RCSI Education & Research Centre, Beaumont Hospital.

Download the course booking form here.

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

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:

Note : This conference has been postponed

The 16th annual conference of the UKCRF Network will take place July 9-10 2020, hosted by the Leicester CRF.

Registration will open in February 2020 and further details can be found on the UKCRF Network website.

Meanwhile poster abstract submissions are invited – check our News Page for details.

Additional details of the conference will be updated here when available.

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:

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:

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:

Save the date for the 13th annual conference of the Irish Research Nurses Network – 3rd & 4th November at the Limerick Strans Hotel.

Further details will be published shortly via IRNN social media channels

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:

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: