Components of a Research Protocol

In general, you should use a template for your research protocol. These are available on Basecamp/NCIL Core/Resources. This provides an overview of these components as well as some explanation.

Title Page

This should include the name of the study, a subtitle that it's the Research Protocol, and the name(s) of the Principal Investiagtor and any other participanting researchers (this should match what is on the REB documents). The REB protocol number (which you get when you submit to the REB) should be here.

The footer of the document should include a version number and date. Ensure that you update these any time you make substantive changes to the protocol (i.e., not fixing typos, but anything that would make a meaningful difference in how the study is run).

Recruitment/Screening

Document how you will recruit participants, study inclusion/exclusion criteria, and where the screening form is saved on the server.

Pre-Participant Preparation

As discussed under Before Each Participant Arrives, there are numerous things you need to do to prepare for each participant. Document these here, step-by-step. For documents that must br printed, specify where on the server they are saved.

Procedure for Each Participant