Training & Conferences

An Introduction to Good Clinical Practice for Investigators and Site Staff ICH E6 (R2)

The Wellcome Trust HRB Clinical Research Facility, St. James’s Hospital will host “An Introduction to GCP” training courses for Investigators and Site Staff on the following dates

• 9th Sep 2019
• 15th Nov 2019

The courses provides training for investigators and site research staff on ICH E6 (R2) (GCP).  The course includes a brief introduction to the national regulatory framework, Principles of ICH-GCP, Investigator Responsibilities and Essential Documents.  The course is delivered with a practical focus and provides workshops and opportunities for discussion.

Each course running from 2-5pm. in the CRF Seminar Room.

Take ‘Route 3’ from main hospital concourse. following signs for CRF/CAMI/H&H. The conference room is located on the ground floor, opposite the lifts.

For further information or to book a place on one of the upcoming courses, please contact Anna Baczek at burdzana@tcd.ie

Certificate of attendance will be provided on the day.

Accredited by the Nursing and Midwifery Board of Ireland (3 CEUs)

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, HRB CRF-C Research Nurse: Jean Foley and Site Monitor 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:

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

The National Children’s Research Centre based at Our Lady’s Children’s Hospital, Crumlin, delivers ‘Introduction to Paediatric Clinical Research & Good Clinical Practice (GCP)’ training courses for Investigators and associated research site personnel.

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 Paediatric Drug Development and Clinical Research
• Research Ethics and Research Governance
• Principles of ICH-GCP (including integrated addendum E6 (R2))
• Investigator Responsibilities
• Essential Documents
• Regulatory Inspections

It also includes practical workshops and opportunities for discussion.

Scheduled dates for 2019

• 10th April 2019
• 12th June 2019
• 27th September 2019
• 29th November 2019

The course is accredited by the Nursing & Midwifery Board of Ireland (NMBI) – 6 CEUs. It also 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 NCRC delivers the course at no cost to paediatric clinical research staff.

For further information, or to book a place on one of the upcoming courses, please contact gcptraining@ncrc.ie

Additional dates may also be facilitated at alternative locations for groups of 10 or more.

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, HRB CRF-C Research Nurse: Jean Foley and Site Monitor 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:

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, HRB CRF-C Research Nurse: Jean Foley and Site Monitor 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:

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

Save the Date for the IRNN Annual Conference

13th – 14th November 2019 at The River Lee Hotel, Cork.

Conference Theme  “Research Nurses/Midwives Roadmap”

Further details and agenda to follow. Contact hello@irnn.ie for information

An Introduction to Good Clinical Practice for Investigators and Site Staff ICH E6 (R2)

The Wellcome Trust HRB Clinical Research Facility, St. James’s Hospital will host “An Introduction to GCP” training courses for Investigators and Site Staff on the following dates

• 15th Nov 2019

The courses provides training for investigators and site research staff on ICH E6 (R2) (GCP).  The course includes a brief introduction to the national regulatory framework, Principles of ICH-GCP, Investigator Responsibilities and Essential Documents.  The course is delivered with a practical focus and provides workshops and opportunities for discussion.

Each course running from 2-5pm. in the CRF Seminar Room.

Take ‘Route 3’ from main hospital concourse. following signs for CRF/CAMI/H&H. The conference room is located on the ground floor, opposite the lifts.

For further information or to book a place on one of the upcoming courses, please contact Anna Baczek at burdzana@tcd.ie

Certificate of attendance will be provided on the day.

Accredited by the Nursing and Midwifery Board of Ireland (3 CEUs)

The National Children’s Research Centre, based at Children’s Health Ireland at Crumlin, delivers ‘Paediatric Good Clinical Practice (GCP) Refresher’ training courses for Investigators and associated research site personnel.

This half 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 Paediatric Drug Development and Clinical Research
• Research Ethics and Research Governance
• Principles of ICH-GCP (including integrated addendum E6 (R2))
• Investigator Responsibilities
• Essential Documents
• Regulatory Inspections

It also includes practical workshops and opportunities for discussion.

Scheduled dates for 2019

• 17th July 2019
• 29th November 2019

The course is accredited by the Nursing & Midwifery Board of Ireland (NMBI) – 3 CEUs. It also 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.

For further information, or to book a place on one of the upcoming courses, please contact gcptraining@ncrc.ie

Additional dates may also be facilitated at alternative locations for groups of 10 or more.

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, HRB CRF-C Research Nurse: Jean Foley and Maria Spillane site Monitor.

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:

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