This area provides resources for professionals involved in paediatric clinical trials. Use the tabs below to access information and resources.
What does registration mean?
To be registered with the ScotCRN portfolio studies must:
- Improve the safety, efficacy or availability of medicines or treatments for children
- Increase the scientific knowledge that may lead to improved or new medical or health care treatment in children.
- Be scientifically and statistically valid
- Be approved by the appropriate ethics committee
- Have NHS R & D approval
- Be appropriate and achievable in the Scottish healthcare system
- Be funded commercially or by a charity on the CSO eligible funders list (Version 3) effective from 1.8.12
- Provide recruitment data on an agreed template to the ScotCRN Data Manager
What are the advantages of registration?
Eligible studies adopted on to the ScotCRN portfolio are entitled to support from the coordinating centre, and ScotCRN nurses in:
- Identifying appropriate sites and principal investigators
- Feasibility studies
- Patient Identification and Recruitment
- Access to dedicated Children’s Research Facilities
- Data Collection
- Pharmacy support
- Design and content of age appropriate information and consent/assent sheets
- Troubleshooting and support if recruiting below target
Is support provided before registration?
If a study meets the remit of the network and funding eligibility investigators can request expert advice and support prior to ethical approval i.e.
- Protocol development
- Research governance
- Content and design of age appropriate information sheets and consent/assent forms
- Pharmacy support
- Advice on recruitment strategies
How to register your study with the ScotCRN
Please complete our Registration Form and return it by email. If you need any help or assistance with completing the form please contact the Network manager or any of the ScotCRN nurses. Once we have received your completed registration form we will contact you directly.
This page contains a toolkit of indispensable resources for professionals involved in clinical trials. Click on the icons to access more detailed info and resources.
The Role of the Research Nurse in the ScotCRN
Research nurses play a vital role in the ScotRN and are all qualified paediatric nurses. They have completed core research training specific to the challenges and complexities of engaging with children and young people.
The nurses ensure their own training and professional practice meets the standards and competencies identified in the ScotCRN Training & Education Framework.
A list of current ScotCRN network SOP's can be viewed by following the link in the grey box on the upper right hand side of this page.
Provide support and mentorship for all clinical research staff and students
Research nurses can provide support and mentorship for all clinical and non-clinical trials including study specific staff training, clinical supervision and mentorship. A core principle of mentorship is to ensure Good Clinical Practice (GCP) is incorporated into all research activity.
GCP is an international ethical and scientific quality standard for the design, conduct and record of research involving humans, comprising of 13 core principles. GCP applies to all clinical investigations that could affect the safety and well-being of human participants.
Oversee and participate in the safe and efficient running of clinical trials
Research nurse involvement is available from the conception of the study to completion. Through study adoption nurse support can assist with the development of study documentation, study set up, recruitment to target, consent & assent and retention of participants.
Promote the ScotCRN
The Lead Research Nurses are responsible for ensuring leadership in each of the centres to promote the ScotCRN profile, involvement in local research communities, presenting at research forums, and involvement internationally within the UKCRF Paediatric Forum.
- Setting up family friendly CRFs at each node
- Benchmarking and networking to develop nursing research standards and competencies across the UK
- SOP’s available to professionals undertaking research with children
- Consistently recruiting to target
- Increased PI satisfaction resulting in repeated activity
- Collaboration with other topic specific networks: Mental Health, Primary Care, Diabetes, and with Managed Clinical Networks e.g. Paediatric Rheumatology MCN
- Facilitating the establishment of the first Young Person’s Group in Aberdeen
- Working together to develop a standard for Consent & Assent.
- Increased research activity for public/commercial and CTIMP/NonCTIMP studies
- Linking to Primary care e.g. PAGES study