Submit Amendments, Unanticipated Problems (including SAE’s) etc.?

Create, and submit a new package for the project. The following steps will help ensure a smooth submission.

Create a New Package for an Existing Project in IRBNet

1. In your Study Manager click on the title of the project to go to the Project Overview page.

2. Click the Project History button to the left.

3. Click the Create New Package button in the middle of the page.

4. Click the Designer button to work on documents for the new package via two methods (described in detail below):

METHOD #1: Revise a previously submitted document (e.g. for amendments etc.)
or
METHOD #2: Attach a new document to the package (e.g., continuing review application, Unanticipated Problem Form, etc).

 

METHOD #1: Revise or Submit a Previously Submitted Document for Review (Designer page)

Refer to the ‘Documents from Previous Packages’ section at the bottom of the Designer page.

1. To revise the Registration Form from a previous package for committee review:

  • Click on the pencil icon for the Registration Form. This will open up the Registration Form.
  • Make any necessary changes to previously entered information and save. The document will move to the ’New and Revised Documents in this Package‘ section.

2. To revise an uploaded document (.doc, .xls, .pdf, etc.) from a previous package:

First download the document by clicking on its Document Type or the paper icon. If you will be revising a consent document, be careful to ensure that the document in your designer that you will be downloading and revising is identical to the most current, stamped, IRB-approved version that sits in the Board Documents.

  • Make necessary changes and save the revised document to your computer.
  • Click on the pencil icon for that document in the Designer.
  • Browse your computer, select your revised document to upload, make necessary changes to Document Type and Description (below), and click the Update button.
  • When you click Update, the revised document will appear in the current document package (‘New and Revised Documents in this Package’) with a revision history (the ‘stack of paper’ icon) that reflects versions from previous packages (see below).

 

METHOD #2: Attach a New Document to the Package (Designer)

1. Complete applicable forms downloaded from the Library, or create applicable documents on your computer.
2. Use the Add New Document button to upload the document into the current package. The document will not have a revision history (stack of paper icon) at this time as it is new.

ONCE YOU HAVE COMPLETED CONSTRUCTION OF THE PACKAGE USING EITHER METHOD

  • Obtain appropriate signatures (see section V, VI).
  • Submit the package to the Stony Brook University Human Subjects Committee (IRB) by clicking the ‘Submit this Project ’ button on the left. You will be submitting to the Stony Brook University Human Research Committee (IRB). You will choose the most appropriate submission type (e.g., ‘Modification/Amendment’ , ‘Reportable Event’ etc.).
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