Developing a protocol

Pre-specifying your Research Question and Writing a Study Protocol

Note

This section is a work in progress, and will be further developed.

Briefly, pre-specifying your research question and developing a study protocol which outlines your planned methodology is an important open science principle. Doing so can help reduce 'researcher degrees of freedom', and in turn minimise the risk for questionable research practices (such as "hypothesising after the results are known" (HARKing) or p-hacking).

Taken together, this can improve both the quality and credibility of your research. Developing a detailed study plan, including figure and table shells, can be particularly helpful when using a federated analytics platform such as OpenSAFELY, as there is less scope for interactively developing these whilst working with the data.

This page will eventually contain resources for how to develop an effective study protocol, as well as tips for how to pre-register these formally on OSF or ENCePP, or informally by uploading "locked" protocol versions to GitHub. There is no specific template for a protocol that you should use when working with OpenSAFELY, but you can see examples of protocols we've written for OpenSAFELY studies on most of our public repositories — for example this inhaled corticosteroid (ICS) research repository or this ethnicity research repository.