Applies to: All research studies
Once a submission has been assigned to an HRPP professional staff member (called a “screener”), (s)he will review all the information submitted, including attached documents. This is known as “pre-review.” If the screener has any questions or concerns with, or requires revisions to your submission, (s)he will take the Return to PI action in KC IRB. You (and any Co-PI and aggregator listed on the KC Protocol) will be notified via email that action is required on your part. Your submission will not be processed further until you have addressed the comments and re-submitted back to the IRB. If you do not re-submit within two weeks, your submission may be administratively withdrawn.
To ensure your study is processed in a timely manner, please follow the instructions below for responding to pre-review.
From the Kuali Financial & Research Services (KFS) dashboard:
- Click KC IRB from the left-hand navigation bar. A list of activities you can perform is displayed.
Click Search Protocols from the list of KC IRB Activities. The Protocol Lookup window will open. You can search for the protocol using a variety of search fields. Partially populate any field, and add an asterisk *, to return a list.
- To search by Protocol number: Enter protocol number, followed by “*” in the Protocol # search field (e.g. 1701123456*). Click search.
- To search by Investigator, i.e., PI: Enter the Last Name of the PI followed by “*” in the Investigator search field (i.e. Smith*). Click search.
- Select edit under the actions column, next to the protocol for which you want to respond to. (NOTE: the study/submission should display a Protocol Status of Return to PI. When responding to a pre-review to a post approval submission, you should locate the appropriate submission.
- For amendments, search for an A00X suffix added to the protocol number, e.g. 1234567890A001.
- For renewals, search for an R00X suffix added to the protocol number, e.g. 1234567890R001.
- For FYIs, search for an F00X suffix added to the protocol number, e.g. 1234567890F001.
- For initial applications, there will be no suffix, e.g. 1234567890.
The KC IRB Protocol is setup using a system of tabs. Within each tab, are "folders", which contain bits of information about the research protocol. Expand the sections below to see tab specific instructions.