Protocol Builder

Protocol Builder is a web-based application that offers over 10 different standardized protocol templates for investigator initiated biomedical and social behavioral research. It provides step-by-step instructions on creating a research protocol, allows researchers to collaborate on projects, tracks changes for protocol amendments and creates a summary of changes document that can be submitted to the IRB for review. Once you complete a protocol in Protocol Builder, you can generate a WORD or PDF file of the document and upload it into IRES IRB.

You will need a Yale netID and password to log into the Protocol Builder system.

Protocol Builder Training Options

• Protocol Builder Website
• Protocol Builder Tour
• Protocol Builder FAQ
• Webinar Training

What You May Want to Know

Do I need to use Protocol Builder to create a research protocol for submission to the IRB? No, you do not have to use this application.

There are also protocol templates available in IRES IRB. However, you are strongly encouraged to use the Protocol Builder as it will allow you to collaborate with other members of the research team when building a protocol and help you track changes for amendments after the protocol approval.

I created a protocol using Protocol Builder. Do I need to use any other forms at the time of submission of the protocol to the IRB?

Yes. Research protocols may not include sufficient information about the local information that the IRB needs to review to approve a study. This is especially true when protocol is used at multiple sites. In that case, things like recruitment or confidentiality of data may differ from site to site. IRBs developed their own versions of a submission form that needs to be completed when submitting the protocol for review. If you are submitting the protocol to Yale IRB, use the Submission Form available in the IRES IRB Library. If you are submitting a protocol to an external IRB, refer to that IRB’s submission procedures.