Once a project has been approved by the IRB, the Principal Investigator (or Research Adviser in the case of student PIs) is responsible for making sure the project is carried out as approved. Any changes in documents, verbal scripts, methodology, investigators, numbers of subjects, etc. need to be approved by the IRB through a Revised package.
Revisions to approved projects need to be submitted in a subsequent package. To create a subsequent package, click on "Create a New Package" located just below the Project History Link on the left toolbar within the package. Revised packages are reviewed by the IRB Chair and can be conducted quickly when investigators prepare their revised package as follows:
The PI must maintain and secure all paperwork as described in the approved RPA. In addition to supervising research activities, the PI is also responsible for reporting any unexpected project outcomes or events to the IRB. See the Adverse Event Tree for guidance on how to report an event.