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Good Clinical Practice Courses (RCSI)

April 28 - December 31

|Recurring Event (See all)
These modules are delivered online. There is no fixed start date and completed at the students own pace.

***These modules are delivered online. There is no fixed start date and completed at the students own pace.***

Course Title Introduction To Clinical Research & Good Clinical Practice: Online Delivery
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:

Ø  Introduction to Drug Development and Clinical Research

Ø  Research Ethics and Clinical Research Governance

Ø  Principles of Good Clinical Practice

Ø  Investigator Responsibilities

Ø  Regulatory Inspection

The course has Category 1 Approval from 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 by trial sponsors

Available online during Covid-19 disruption. Contact Deirdre Hyland for further information – dhyland@rcsi.com

Course Title Good Clinical Practice (GCP) Refresher Course:  Online Delivery
A half day course relevant to Principal Investigators, Research Nurses and associated research site staff who have attended a full GCP training day within the last two years.  The following content is included:

Ø  Clinical Research Governance (Revision & Updates)

Ø  Principles of Good Clinical Practice

Ø  Investigator Responsibilities

Ø  Regulatory Inspections

The course has Category 1 Approval from the Nursing & Midwifery Board of Ireland (NMBI). All attendees are eligible for 4 CEUs on completion.  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.

Available online during Covid-19 disruption. Contact Deirdre Hyland for further information – dhyland@rcsi.com

Course Title Good Clinical Practice in Medical Device Research: Web-based delivery
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:

Ø  Principles of Good Clinical Practice

Ø  Medical Devices (What is a Medical Device; Types & Classification; Medical Device Legislation; Clinical Investigations)

Ø  Good Clinical Practice in Device Trials (Ethical Issues; Conduct of a Clinical Investigation; Safety Reporting in Device Research)

Ø  Monitoring & Audit

Booking Information This course is currently offered as a study day via MS Teams. Upcoming dates: 27th May, 09.30 – 15.30.

Cost: €60.00 per person. To apply: Complete RCSI Course Booking Form and send to Deirdre Hyland – dhyland@rcsi.ie . Payment may be made via link on booking form.

 

Details

Start:
April 28
End:
December 31
Event Category:

Organiser

Deirdre Hyland
Email:
dhyland@rcsi.ie