Paediatric Protocol Templates
Protocol and study-development resources for teams planning paediatric clinical research.
About these resources
Murdoch Children’s Research Institute (MCRI) has developed protocol templates and related research toolkits that can support investigators as they shape a study question, protocol and ethics documentation. These materials are reference resources: research teams remain responsible for using the current requirements of their institution, ethics committee and study sponsors.
Using templates in a trial-development workflow
For a multi-centre paediatric study, a useful early step is to agree the research question, population, outcomes, governance pathway and data requirements before circulating a protocol draft. PTNA’s Clinical Epidemiology and Biostatistics resource outlines where methodological input can help, while the Concept Development Scheme may be relevant for investigators developing a new multi-centre trial concept.
Visit Research Workshops for the wider PTNA capability-building collection, or contact PTNA to discuss an enquiry with the Secretariat.
A practical protocol checklist
A useful protocol should make the study question, population, intervention or exposure, outcomes and analysis approach understandable to every participating site. It should also define recruitment, consent, safety reporting, data handling, governance responsibilities and the process for documenting changes.
Templates organise that work, but each study still requires specialist review. Pair this resource with biostatistical input, ethics and governance guidance, and the wider PTNA workshop collection.