Satisfy SBU Application Requirements for CRRI Studies (Using IRBNet)

Initial Submissions

If you are not already registered and/or if you have not yet created a study on IRBNet, please follow the directions available on our website.

A. Create a study, complete initial fields, and when it is time to download, complete, and upload documents back into your study designer, do so with the following documents from the forms and documents library of IRBNet:

1.       Registration Form for Expedited or Full CORIHS Review: This is a short ‘smart’ or ‘wizard’ form that quickly captures critical, searchable data pertaining to your study. To access this document:

  • 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.

2.       SBU IRB/Institutional Fee Invoice Authorization Form

3.       SBU Scientific Merit Review Form: The application materials must be endorsed as scientifically meritorious by either the department chair or departmental review committee of all departments impacted by the proposed activity.

4.       SBU University Hospital Form: This form is necessary to assess impact of the proposed activity on UH patients, services and facilities.

5.       Inclusion/exclusion criteria checklist: This checklist should contain required eligibility ranges where applicable, and a line to write the subject’s actual value. Completed and maintained for each subject, along with all backup documentation (lab values, x-ray reports, confirmation of diagnosis etc.), this information will provide definitive proof of your study subjects’ eligibility. 

6.       The Study Protocol

7.       If the study involves drug/biologics where the services of the Investigational Drug Pharmacy are not used for storage, dispensing, and accounting of the agent, the following must be submitted in a cover letter, and the package must be shared with ‘Research Pharmacy’ for their endorsement:

  • Where are the drugs/biologics being stored? 
  • Describe the security of the storage unit/facility.
  • Provide full detail regarding dispensing of the drug(s), how labeled, controlled (accountability, disposition of unused drug at the conclusion of the investigation) and documented (accounting records/logs)

8.   'External IRBs: Principal Investigator Certification' document: This outlines the requirements to which the PI must certify when s/he e-signs the IRBNet package. If the PI is not the individual creating the submission package, be sure the PI is made fully aware of the contents of this document before his or her e-signature is provided. 

B. Make sure you share the package with all study personnel and thedepartment chair (or designee), but only the PI and chair e-signatures are required. 

C. Submit the Study in IRBNet to Stony Brook University IRB.

 

 

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