Starting June 30, 2016, study teams began receiving e-mails directly from the KC IRB system when the HSO completed pre-review on their protocols. This email provides basic protocol information, links to pre-review comments and revised documents, detailed instructions on how to respond to the pre-review, and contact information for their HSO screener.
- After the HSO screener completes pre-review, he/she will add comments, and upload into KC IRB any necessary documents with tracked changes, including a PDF of the KC Questionnaire(s) with comments. The screener will then take the Return to PI action in KC IRB and the status of the protocol will change to Return to PI. This status change opens the protocol for editing.
- An email is then sent to the study team, i.e. PI, Co-PI, aggregator, study manager, alerting them that the protocol has received pre-review and action is required on their part.
- The study team should review comments and attachments in KC IRB and address the screener’s requests appropriately. Detailed instructions on responding to pre-review can be found HERE.
- When all requests have been addressed, the researcher must take the Submit to IRB action on the Protocol Actions tab in KC IRB. This will notify the HSO screener that a response has been submitted.