- Support with protocol development and design
- Advice on paediatric specific aspects
- Statistical support is available for academic Investigator Led Studies
We offer a comprehensive range of services to Principal Investigators, Clinical Research Staff and Study Sponsors, from the early stages of protocol development through to study delivery and closure. We support Clinical Study Teams at our local site, Our Lady’s Children’s Hospital, Crumlin, as well as other paediatric hospitals across Ireland.
As well as supporting sites to participate in multi-centre studies, we also operate at a study level, providing a central multi-centre trial management service.
The services we provide include:
We operate a paediatric feasibility service fielding new study feasibility queries and connecting Study Sponsors with potential Investigators. This includes:
In addition to the existing NCRC’s network of collaborators, in 2015 we embarked on a formal partnership with PPD, a leading global contract research organization, to establish a Paediatric Investigator Network (PIN). The PIN is made up of over 60 Paediatricians from across Ireland, and is one of a global network of 12 partnerships to connect study sites with clinical study sponsors.
The following are some of the supports available to Study Sponsors and Site Study Teams to assist with study start-up activities:
Each study is assigned a dedicated Study Coordinator to guide Investigators and Clinical Teams through study set-up, conduct and closedown. According to the individual study requirements, this may be a Clinical Research Coordinator or Research Nurse. Support may also be provided by a Research Assistant.
The Study Coordinator’s responsibilities include:
Skilled paediatric nurses with clinical and research expertise support Investigators and Clinical Teams by:
Our Data Management group can provide the following services:
We can provide assistance with the collection, processing, shipping and storage of biological samples.
A Quality Management System (QMS) based upon Good Clinical Practice (ICH GCP) Guidelines and all applicable regulatory and ethical requirements is in place to ensure that all research supported by the CCRU is conducted to the highest standards of research and clinical governance. Consisting of policies, standard operating procedures and internal auditing and quality control measures, it ensures that the highest standard of excellence and safety in treating children and young adults is achieved.
It is the NCRC’s policy that all staff working on CCRU supported studies must receive ICH GCP training.
The following paediatric specific GCP training courses are regularly conducted by our in-house GCP trainers:
Scheduled dates for 2019
Introduction to Paediatric Clinical Research & Good Clinical Practice (GCP) – Full day course
Paediatric Good Clinical Practice (GCP) Refresher – Half day course
Both courses are accredited by the Nursing & Midwifery Board of Ireland (NMBI) – 6 CEUs and 3 CEUs, respectively. They also meet 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 email@example.com.
Additional dates can also potentially be facilitated at alternative locations for groups of 10 or more.
The supports we can provide include:
We offer a trial management service for multi-centre studies which includes the following:
To discuss how we can assist you or for further information, please contact the CCRU Team.
To apply for support directly, please complete the CCRU Application for Support Form