By Rayamond Nomizu, JD, CEO & Co-founder at CRIO
eSource is the bridge between the protocol and the eCRF fields. To understand why, we need to understand what each does.
The protocol describes the purpose of the study, the core hypotheses, the endpoints that are to be collected, and the resulting procedures to be performed to support those endpoints. The eCRF then translates a subset of those endpoints (i.e., the ones collected by the research site) into target data fields to be completed by site personnel.
While the eCRF is a distillation of the key fields required for analysis, it does not cover all the specifications of the protocol. This is because the protocol specifies not only the target endpoints, but also the workflows that support those endpoints.