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a. Project= this is the study as a whole; Create the project ONCE (enter / type the title one time)
b. Package=this is an individual submission to the IRB within that study; multiple packages will be created / submitted (initial submission, amendments, renewals, deviations, adverse events, etc.)
3. The IRBNet ID number is not the same as the protocol number that the IRB normally assigns, but it is useful. Once the project has been created, it is assigned a six digit number. That number is followed by a dash and then a single number (XXXXXX-1). The number after the dash refers to the number of packages within the project. Therefore, XXXXXX-3 means that project XXXXXX has had 3 packages.
i. Think of the Project as a binder and a Package is a tab in that binder.
a. The IRB will be using this number, as well as the USA IRB assigned number to refer to the packages
a. If the option requests a certain document-Please attach this document, i.e., Checklist for Children because the project includes working with minors. The IRB Office will not review the project until it is complete; it will be unlocked (notification through IRBNet to all key personnel regarding the missing information will be made) until all requirements have been attached.
b. Check all that apply - Most of these questions allow for multiple answers. Patient volunteers, need to be selected, as well as, in-patient and/or out-patient. If multiple options need to be selected in other parts of the application, but IRBNet does not allow this, please contact the IRB.
a. Work in Progress= you have not submitted the package, you are still working on assembling the package
b. Pending Review= you have submitted the package the IRB; check the Project Overview Page for the receipt for submission
c. Modifications Required/Information Required= the package has been reviewed and there are pending revisions for the study for you to address
d. Approved/Acknowledged/Closed=the package has been reviewed and there are no pending modifications
a. = The package is locked and has been submitted to the IRB
b. = The package has been unlocked and revisions are pending (you need to take a look at something)
c. = The package is now locked again and the requested revisions have been addressed.
d. There is no lock = The package has not been submitted to the IRB
a. To silence the Reminders, go into My Reminders and click . The reminder is not gone, but it will no longer appear on the list. If you wish to see them again just click Show Silenced Reminders above the list.
a. For Expedited/Full Board Submissions: the PI, the department head and the hospital administrator (if applicable) signs the project electronically.
b. For Exempt Submissions: The PI signs the project electronically.
c. Students: The PI and the Advisor must electronically sign whether exempt or expedited.
d. For any other submissions (i.e. renewal, deviations) only the PI needs to electronically sign.
e. For sponsor letters or advertisements, no signature is required.
a. = this will allow you to access the document; clicking on the title highlighted in blue
b. = this allows editing Part A or updating documents that have been attached. This button will disappear once the package has been locked/submitted
c. = this allows documents to be deleted that have been attached to the package. This button will disappear once the package has been locked/submitted
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