Create and Submit a Five (5) Year Continuing Review Package

  • If you are unsure as to whether you need to submit a ‘Regular’ or ‘Five Year’ continuing review application, go to section XI.2 for a discussion of how your CORIHS# reveals the answer.
  • Consent documents should be submitted in Microsoft word, and should not be submitted on letterhead.
  • You can also take a document from a previous package of the project in IRBNet, revise it, and submit with the current continuing review package. See Section IX for instructions.

Create a new package to your previously approved project:

  • Go into your ‘My Projects’.
  • Click on the exact IRBNet project (including same suffix) referenced in the e-mail you received reminding you to renew your study
  • Go into Designer, and select 'Add New Document' at the bottom of the page, then select Create New Package’

Complete the Registration Form for Expedited or Full CORIHS Review:

  • Go to your project’s Designer
  • Select ‘Add New Document’
  • In the lower shaded ‘On-Line Document’ box, select ‘Registration Form for Expedited or Full Committee Review’, then hit the ‘Add’ button
  • Begin completing the Registration Form. You do not need to complete the whole form in one sitting; you can ‘save and exit’, and then go back and update the document by clicking the pencil icon next to the document listed in the designer.
  • When you are done completing the registration form, click “Preview” to see what the completed form looks like, and confirm that all the information provided is accurate. Once you are satisfied in this regard,

Click "Save and Exit", and then continue constructing your project package to completion:

  • Download and complete the "Application for Five Year Continuing Expedited or Full CORIHS Review", a downloadable document located in the project’s Library (found on Designer page, step one) that will capture more detail about the answers you provided in the Registration Form.
  • Download and complete other required, downloadable forms (found on Designer page, step one), in accordance with the requirements outlined in the CORIHS Submission Requirements for Continuing Reviews (Regular and Five-Year)  which is also available in the project’s Library. Examples of such forms are the consent templates for customization to your study, ‘Application for Approval to Conduct Research at University Hospital’, and Supplemental forms (if your project is proposing use of questionably viable or nonviable neonates, international sites, prisoners, or must comply with ICH-GCP). Once completed, you will upload the completed forms from your computer. You will need to supply a ‘document type’: select the descriptor that best describes what you are uploading. If unsure, select ‘other’ and provide the description you want in the field called ‘description’. Then browse and find the document for uploading from your computer by clicking on ‘Add New Document’ in the Designer, and using the top shaded area on the next screen.
  • When, during uploading your forms, you are asked for ‘document type’, select the descriptor that best describes what you are uploading. If unsure, select ‘other’ and provide the description you want in the field called ‘description’. Then browse and find the document for uploading from your computer.
  • Upload other documents from your computer to complete the submission, such as sponsor protocol, investigator brochures, advertisements etc, by clicking on ‘Add New Document’, and using the top shaded area on the next screen.
  • Share with your project team members.
  • Obtain appropriate signatures.
  • 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 submission type ‘Continuing Review/Renewal’.

 

 

Go to top