This article provides a protocol for the joint analysis of the prospective cohort studies of the ZIKAlliance, ZikaPLAN and ZIKAction consortia.
SPIRIT guidelines for Protocol Writing
by SPIRIT-StatementLinks to the SPIRIT guidelines for protocol development and information about these guidelines - all free and open access.
Five seed documents are provided here for use in clinical research, which can be adapted and altered for each study. Here we provide a template concept protocol, a study protocol, a CRF, an informed consent form, and a generic SOP.
The Trial Protocol Tool: a tool to help researchers to write a high quality protocol for a randomised controlled trial AVAILABLE IN SPANISH AND ENGLISH
From concept protocol through to the final approved version, it is important to have input from a variety of stakeholders to ensure a successful trial.