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
The effort invested in pre-trial planning and preparation more than pays off in terms of smooth operations, happy staff, happy participants, good recruitment and ultimately high quality data.
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.