Approved Project Information and Revisions

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:

1. Working from an approved IRB document, highlight in yellow all additions to the document and strike-thru text that will be deleted.
2. Review all approved documents to make sure that documents affected by the revision have been revised and uploaded.
3. If a stamped consent form is being revised, upload a version of the consent form showing the highlighted/strike-thru changes, and a “clean version” that is ready for stamping.
4. Upload a word document that BRIEFLY explains why the project is being revised.
5. If an investigator is being added to a project, be sure to SHARE the project with the investigator and have him/her upload their training certificate.
6. Have all members of the research team (including new members and retiring members, if possible) sign the package.
7. Submit the package as a Revision.

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.