IRB lifecycle

We prefer staff changes to come in a separate package and not with any other changes. Assuming all training is complete, these requests are typically processed quickly. If staff changes are embedded with other changes, then new staff need to wait until the entire amendment is approved. This is a situation where it's okay to have two pending amendments.

In general, no. Any modifications to the conduct of the study or study documents, with very limited exceptions, must be submitted to the Children's Wisconsin IRB for approval via separate amendment package.

An exception is that if there are individuals who are no longer part of the study team, and a previous amendment was not submitted to remove them (as should have happened), the Children's IRB will allow the registration page and any other affected study documents to be updated and remove those individuals at the time of continuing review.

• Note: If the individual has transferred to another institution and will continue to collaborate on the research, Children's IRB must consider whether that institution is engaged in research, which may invoke a reliance determination.
• It is important to note that if the individual being removed is the principle investigator (PI) OR their removal would have an impact on the conduct of the study, (for example the individual is responsible for a key component of the conduct of the research) and an amendment to replace the individual has not already been approved, a separate amendment will need to be approved by the Children's HRPP/IRB before removing that individual.
• Those individuals being removed must be listed in the CPR form as indicated in Section I.
• Any additions to the study team require a separate amendment.
• Any documents that are updated to remove staff (with the exception of the registration page) must be submitted with changes tracked.
• Any documents updated to remove staff must NOT include any other revisions.
• Failure to comply with the above may result in delayed processing of the continuing review, and potentially lead to a lapse/expiration of the study.

This varies depending on the nature of the study. Please refer to the decision chart for the minimum recommended clinical research coordinator documentation in Epic for Children's patients. There is also a video/PowerPoint presentation on this topic available on the research education and training page under, "Quarterly education sessions" from Mar 22, 2016.