Components of a paediatric clinical trial infrastructure
| 1 | A human subject protection oversight mechanism, typically an ethics committee or institutional review board |
| 2 | Clinical trial competence concerning startup, budget, agreements and coordination |
| 3 | A facility for observation and data collection that is supportive of the needs and expectations of children and families |
| 4 | Personnel combining expertise in paediatrics and clinical trials |
| 5 | Laboratory facilities that can process small quantities of biological samples that may be labile or have particular storage requirements |
| 6 | Secure data transmission and archiving facilities |
| 7 | The capacity to be interoperable, that is, to communicate and function efficiently and without loss of fidelity, with other components of the infrastructure and ideally with other clinical research facilities and oversight and regulatory authorities |