This page will be periodically revised to reflect new information for the investigators and research staff working within the iStar system. As more training resources are developed, this page will link directly to the resources that are relevant to the investigator community. Please check back often.
How will it affect me?
The PI and study team will create and submit a single application to any of the three participating IRBs.
The application is prepared via a “smart form” that presents only those sections of the application that are relevant to the current study.
The system contains detailed questions with context-specific guidance to assist in the creation and review of study applications.
Validation of the application before submission will catch common mistakes and reduce the number of changes required after submission.
The application, once submitted, is routed to the appropriate organizations (i.e., faculty advisor, and academic units) for review and signoff before being received at the IRB.
All reviewing committees and study team see the same version of the application.
The study team can see where the application is in the review process at anytime by checking their individual webpages.
The review and approval of the study application is done online.
Email notifications will be sent to the PI and study team anytime the application is sent back for requested changes by a reviewer.
The approval letter will be sent to the PI and study coordinator via email. A copy of the approval letter and approved consent forms will be posted with the study and available for download at anytime.
All changes to the application and correspondence between the study team and IRB will be logged and time stamped.
How do I use it?
Complete instruction booklets as well as web-based tutorials are in the process of being developed to explain the system in its entirety. However, the steps listed below are the minimum steps the study team needs to complete in order to submit an application: The PI or Co-Investigator must submit any adverse event; however, any member of the study team can submit amendments and continuing reviews. A summary of the review process is listed below.
Enter and review application information online via a personalized webpage (Note: a printer-friendly version of the application is available for review).
The PI must make the initial submission from his/her webpage (Note: this is equivalent to the PI’s signature on the application).
Anyone on the study team with authorization can re-submit the application if corrections are made.
Application Review Process
Step 1
PI & Study Team
Prepare and submit application.
Step 2
Pre-Reviewers
If applicable, the application is routed to the following people/organizations for approval and sign-off:
Faculty Advisor
Division Chiefs, Department Heads, and School Deans of the study investigators
Step 3
IRB Staff Review
An IRB Administrator will be assigned to the study. The IRB Administrator will conduct a staff review and manage the scheduling of the study.
Step 4
IRB Review
The IRB committees or a chairperson (for expedite/exempt studies) will review the application and either provide feedback for the study team to address or an approval. Committee decisions, feedback and approval letter are recorded by the IRB Administrator in iStar and sent to the PI & Study Team.
Step 5
Response
If feedback on the study was received, the PI & Study Team will prepare a response and submit to the IRB. Then, steps 3 and 4 will be repeated.
Step 6
PI & Study Team (once study is approved)
Conduct research.
Report adverse events.
Submit requests for continuing reviews.
Submit amendments.
What changes are there from the current application?
The ISTAR application contains 41 sections; many of them are only applicable to specific areas of research. The smart form technology will determine which sections are relevant based on the answers you provide. You will still be able to cut and paste sections from MS Word, or other word processor application, into the application. As we get closer to the roll-out, we will provide you with a comparison of the current and new forms.
Where can I get help?
Various methods of instruction and help are listed below. Updates of any of the instruction/training methods will be posted on the iStar site and will be made available as soon as they are completed.
Downloadable Instruction Manual: There is an instruction manual, about 25 pages, which has step by step procedures for creating and submitting a study as well as checking the progress of the review process.
Context-sensitive help/guidance screens: Question specific guidance screens are being developed by the IRBs to assist in completing the study application. Each question subject will have a brief description, guidance from the IRB, and links to all the relevant regulations and guidelines. The guidance will lay out 1) why the IRB is asking the question, 2) what the IRB is looking for in the answer, and 3) a couple of case examples. There will also be technical help screens which will give instructions for website procedures, such as uploading documents and searching studies. Finally, because we are combining the processes and applications of three IRBs, there will be a definition list of common terms with agreed upon meanings.
Web Based Tutorials: Video screen captures will be used to demonstrate the various actions one must perform over the course of the study submission and review. Any or all of the movies for the associated tasks may be viewed to assist you in understanding the procedures of the iStar site. The web based tutorials are still being developed.
“Sandbox” Mode: A training site is available for personal "hands on" training. This training site is not the “real” iStar site, but instead is a copy of the site for you to try out anything you would like. This will allow you to practice creating and submitting “fake” studies without the fear of messing anything up.
Help Desk: The iStar help desk is staffed during normal business hours, allowing you to call in with any technical problems you are having. The help desk troubleshooter is able to view the system, diagnose the problem, and walk you through the fix. The troubleshooter also logs all issues to create and maintain the FAQ, or frequently asked questions, section of this site as well as identify any issues that need further development. During non-business hours, when the help desk is not staffed, you may send email to the help desk email account (istar@usc.edu) and your email will be answered within 24 hours.
Workshop Classes: Instructional classes for the iStar system will be scheduled on an as needed basis. Our hope is to make the previous instructional methods versatile and informative enough that a computer classroom instructional session is not necessary. However, we understand that classroom settings are better learning conditions for some people and will evaluate the need for the workshop classes by posting a signup sheet on the website. When enough people have expressed interest, we will schedule and coordinate a class.
