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:
- Support with protocol development and design
- Advice on paediatric specific aspects
- Statistical support is available for academic Investigator Led Studies
We operate a paediatric feasibility service fielding new study feasibility queries and connecting Study Sponsors with potential Investigators. This includes:
- Assisting with the identification of Principal Investigators
- Coordinating the sign-off of Confidential Disclosure Agreements
- Supporting Investigators to complete study feasibility assessments
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:
- Support with Pre-Study Visits
- Local coordination of Site Initiation Visits
- Collection of key essential documents e.g. CVs and GCP Certificates of Site Staff, obtaining laboratory reference information and protocol and IB receipt confirmations
- Assistance with the development of paediatric specific informed consent and assent documentation according to local requirements
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:
- Serving as the key operational contact between Study Sponsor, the Investigator and Clinical Study Team
- Coordination of study site activities including patient study visits and monitoring visits
- Investigator Site File management
- Data collection, data entry and query management
- Reporting of Adverse Events including Serious Adverse Events according to study timelines
Skilled paediatric nurses with clinical and research expertise support Investigators and Clinical Teams by:
- Playing a central role in patient screening, recruitment and with the Informed Consent and Assent process
- Providing ongoing Parent and Child education and support
- Providing nursing care in the management of research participants
- Performing protocol assessments
Our Data Management group can provide the following services:
- CRF design and development
- Database development
- Data Validation & Quality Control
- Discrepancy Management
- Data review (Ongoing QC/QA)
- Database Lock and Data Transfer
- Project Management and Data Management Plan development
- The main purpose of the research pharmacy service is to maintain control and accountability of investigational medicinal products (IMPs) and non-investigational medicinal products (NIMPs).
- The role of pharmacy in relation to clinical research is to safeguard subjects, healthcare professionals and the hospital ensuring that IMPs and NIMPs are appropriate for use and are procured, handled, stored and used safely and correctly.
- The CCRU has a dedicated Clinical Trials Pharmacist to ensure that IMPs/NIMPs are managed and dispensed to patients in accordance to approved protocols and ensures that all pharmacy clinical trial procedures comply with all relevant guidelines and regulations.
- Additional services provided by Trial Pharmacy include; preparation of prescription templates, treatment protocols etc, feasibility assessments and provision of drug information to doctors, nurses and other healthcare professionals as related to IMPs.
We can provide assistance with the collection, processing, shipping and storage of biological samples.
- All staff involved with sample management receive training in transport of biological specimens.
- Paediatric blood sampling at OLCHC is enabled by the expertise of the Paediatric Phlebotomy specialist team.
- Biobanking facilities at the NCRC’s state of the art laboratory provide freezer capacity for short and long-term biological sample storage at -20°C and -80°C.
- All freezers are equipped with a 24/7 temperature monitor and alarm system.
Regulatory Affairs & Ethics
- Advisory service on regulatory requirements for clinical trials and medical device investigations
- Support with submission of clinical trial and medical device clinical investigation applications to the HPRA
- Support with submission of study applications to the Research Ethics Committee (REC) on behalf of the PI
- Submission of study amendments to the HPRA and REC.
Quality Management System
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.
Paediatric GCP Training
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:
- Introduction to Paediatric Clinical Research and Good Clinical Practice (GCP) incorporating Integrated Addendums (E6R2)
- Paediatric Good Clinical Practice (GCP) Refresher incorporating Integrated Addendums (E6R2)
- The training is targeted towards Investigator and Site Research Staff working on clinical trials of investigational medicinal products.
- These trainings 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.
- They have also been granted Continuing Professional Development (CPD) course Category 1 Approval by the Nursing and Midwifery Board of Ireland.
- Courses are generally located at the NCRC/OLCHC but we are also available to provide training at other locations on request.
- Current courses:
There are courses planned for 2018, however the dates are not yet confirmed. Please check again in the coming weeks.
- To register on an upcoming course or for further information, please contact the GCP Training Coordinator Aoife Connell.
Clinical Trial Agreements
The supports we can provide include:
- An advisory service on research related agreements for Investigators and Sponsors
- Act as Sponsor’s key point of contact on behalf of Investigators for the review and collection of signatures for clinical trial agreements
Study Costing, Budget Review & Finance
- We are experienced in study budget negotiations and have developed a paediatric specific study costing tool for a structured approach to study costing.
- We are available to assist the PI in the development of study budgets to meet the costs associated with conducting a study.
- The CCRU also provides a service to manage invoicing, pass through costs and fund administration.
We offer a trial management service for multi-centre studies which includes the following:
- Central project management
- Regulatory Affairs
- Quality Management, Monitoring & Auditing
- Data Management
- Contract and Financial Management
- Biobanking and Laboratory Support
- Paediatric GCP training
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