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Glossary of Terms in IRBNet
IRBNet Term | Meaning |
|---|---|
| Approved with Conditions | The board agrees to approve your package on the condition that the modifications listed in your "modifications required" letter are confirmed and approved by the board. You will need to create a subsequent package within your project to submit these revisions. Once your package status is, "Approved" and have an approval letter listed in your board documents, you may commence with research. |
| Designer | Section of IRBNet where you will "design" your package. In the left side blue menu, under Project Administration, there is a button for "Designer". In this area you can attach your documents, can find the document library with our sample forms, and complete the application wizard (Application part 1). |
| Internal Reference Number | This function is completely optional. If your department has their own numbering system, separate from the IRB, this is where you could include your own project number. This number cannot be seen by the IRB, only the investigators. |
| Local Board Reference Number | If you are submitting an Amendment or Continuing Review for a project that was reviewed prior to the implementation of IRBNet, this will be your previous IRB approval number. This will help the IRB Office link your IRBNet submission with your previously approved transactions. |
Mark "Revisions Complete" | Term used when making updates to a protocol that is currently going through the initial administrative review by the IRB coordinator. This link can be found next to the Lock Status on the Designer Page. If a package has been unlocked for you during an initial administrative review, you must select, "Mark Revisions Complete" so the IRB office is notified that your package is ready to be reviewed again. |
Package | Each submission submitted to IRBNet for a study is in a package. The ID# is represented as the "Project ID- Package #. Each time a new package submission is made within a study, you submit it under the same main project ID number, but the package number will change. For example “123456-1” is an Initial Application. If the board requests a modification, you would create a new package within your current project, the number would change to “123456-2”. For example, if you are submitting an amendment or final report, you would go into your current approved project and select, "Create a new package". You would NOT select, "Create a new project". |
| Project | Refers to an entire study within IRBNet. Do NOT create a new project when submitting an amendment, revision, or final report. |
| "Read Me First" Document | The first file in the drop down menu of the document library that will have step by step instructions for creating a new project. |
Submission is Locked | Refers to the Lock Status function. When your submission is locked, you cannot make any edits to your package as it is under review by the IRB. |
| Submission is Unlocked | Also refers to the Lock Status function. Your submission may be unlocked by the IRB office to allow for changes based on the initial administrative review. Once a package is officially submitted to the board for review or a decision has been made, no more edits may be made to your package. Any changes needed afterwards would require an amendment. |