Conducting your Study

The NIH Principal Investigator (PI) is responsible for the design, conduct, reporting, and scientific integrity of the research. As the PI, you may a…

A regulatory binder is either a physical or electronic binder used to organize essential documents at the site. It is also important to develop check…

The page outlines the nomenclature study teams are required to use when submitting documents to the NIH IRB.  Each electronic regulatory file must ha…

When your protocol, consent and related documents are ready for IRB review, you need to submit the study to the NIH IRB for review via PROTECT.

When researchers conduct a study, they must make sure that people who join are eligible. To do this, they usually use two steps: pre-screening and sc…

When NIH is the Reviewing Institutional Review Board (IRB), investigators must ensure all reportable events are submitted to the IRB via the Reportab…

Once a study starts enrollment, there may be new risks that are identified that were not anticipated. These can be risks to the physical or mental s…

Once your study gets initial IRB approval, any new changes to the study, including the protocol, consent forms, study tools, recruitment materials, o…

Continuing Review (CR) means the Institutional Review Board (IRB) will regularly review your previously approved, non-exempt human subjects research.…

All non-exempt human subjects research protocols must include a Data Safety Monitoring Plan (DSMP) that matches the size, risk level, and complexity …

A research subject can choose to stop (withdraw) from the study at any time. If a subject decides to withdraw, they must inform the principal investi…

Study closure means formally ending a research protocol when all activities involving human subjects are finished, and you have completed analyzing t…

The Principal Investigator (PI) and study team are responsible for maintaining all study records before, during, and after a protocol is closed. You …