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Frequently Asked Questions (FAQ)

The Frequently Asked Questions section, or FAQ, lists common questions users have and their answers.  The FAQ will be updated as needed to include new questions as they are asked.  Please consult the FAQ to see if your question has already been asked before calling the Help Desk.

General

   
How can I get an iStar account?
How do I start the IRB process?  
Where can I find template forms (e.g. consent document, information sheet), and guidance documents?  
How do I submit my application when the study status is “pre-submission”?  
How do I edit my study?  
How do I obtain edit access to a study?  
When I submit changes, what do I put in the pop-up dialog/text box?  
How do I submit an amendment or continuing review?  
How do I view/print the iStar application?  
What does it mean when the study status says “pending correspondence”? What correspondence do I need to send to the IRB?  
How do I start an Amendment application?  
Why do I get a "Certificate Error" when I login to iStar?  
When I open a document and or link to a study, I get a "Certificate Error" and when I click "Continue", I get an iStar login screen - Why?  
I forgot my password. How do I reset it?  
How do I withdraw a study?  
I was added to the study by the “Edit Guest Access” button. I have read-only access, but I still don't see the study in my inbox, Why?  
I am trying to submit an Amendment but I receive an error stating that “Not All Co-Investigators have agreed to participate”, what does that mean?  
I just received my iStar account and I need access to a study.  
My email address has changed. How can I update my iStar account profile?  
I have moved to a different department. How can I update my iStar profile?  
How can I make a shortcut/bookmark to iStar?  
I would like to use the "Edit Study Personnel" activity in lieu of an amendment. How is this done? Are there any restrictions?  
I have trouble opening up a PDF document in Chrome.  How can I fix this issue?  
 

 

Answers


Q:  How can I get an iStar account?
 
A:  Please refer to the instructions located in Obtaining an iStar Account section.
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Q:  How do I start the IRB process?
 
A:  Request an iStar account by going to the Obtaining an iStar Account section. Next, complete CITI training. Lastly, create an iStar application and submit it to the IRB when complete.
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Q:  Where can I find template forms (e.g. consent document, information sheet), and guidance documents?
 
A:  These are available on the IRB websites. Click the links below.

University Park: http://oprs.usc.edu/upirb/upirb-forms/
Health Sciences: http://oprs.usc.edu/hsirb/hsirb-forms/
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Q:  How do I submit my application when the study status is “pre-submission”?
 
A:  Click the “submit to IRB” button. If you receive an error message, the application is incomplete and must be completed prior to submission.
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Q:  How do I edit my study?
 
A:  Log-in to iStar and click the title of the study you want to modify. On the left hand side of the screen, click the “Edit Study” button below the Study Status Box. Make the changes to the application as needed and save them by clicking “Save” on one of the gray navigation bars at the top or bottom of the screen. Once all changes have been made, remember to click the “Submit Response to Changes/Contingencies” button under “My Activities”.
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Q:  How do I obtain edit access to a study?
 
A:  There are a couple of options available to you. If you need to make editorial changes to a study but will (not) serve in any the following roles: (Principal Investigator, Co-investigator or Faculty Advisor), then you can be added to a protocol via the "Edit Study Personnel" activity; otherwise, you will need to be added via an Amendment. Please note, however, that you will need to have current Human Subjects training before you can be officially added to a given study. In the case of clinical trials, you will need to complete both Human Subjects training and Good Clinical Practice training. You can take these courses online by registering with the CITI website.
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Q:  When I submit changes, what do I put in the pop-up dialog/text box?
 
A:  First, make sure you finish editing the main application and save the changes. When you click the ‘submit response’ activity, give a brief response to each of the requested changes or contingencies to let the IRB know you have addressed them (i.e., point by point). You may type your response in a Word document and then copy and paste it into the text box if you prefer. Note that solely typing your response in this box does not edit the application.
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Q:  How do I submit an amendment or continuing review?
 
A:  Log-in to your iStar homepage. Select and open the approved study you want to modify. On the left hand side of the study workspace, click the “New Amendment” or “New Continuing Review” button. These are below the Study Status Box, and above the My Activities buttons.
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Q:  How do I view/print the iStar application?
 
A:  From your homepage, click the title of the application. Next, click the “Printer Friendly Version” button located on the top left side of the current screen. Click the “print” button on the top right, then the “close” button.
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Q:  What does it mean when the study status says “pending correspondence”? What correspondence do I need to send to the IRB?
 
A:  This means the designated reviewer has completed their review and the IRB staff can now generate correspondence (e.g. approval letter) for the research team. You do not need to send any correspondence to the IRB.
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Q:  How do I start an Amendment application?
 
A:  In order to submit an amendment, your name must be listed on page 2 of the IRB study application. If you are not listed, ask someone who is (e.g. PI, Co-PI, etc.) to add you by submitting an amendment (which will give you access to create an amendment). To start an amendment application, click the study title from your homepage, and then look to the left side of the screen. Click the button called “New Amendment” to start the application.
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Q:  Why do I get a "Certificate Error" when I login to iStar?
 
A:  When you visit or login to the iStar website, be sure to type-in https://istar.usc.edu in the address bar, not https://istar-chla.usc.edu. The old url: https://istar-chla.usc.edu is no longer supported and contains expired security certificates.
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Q:  When I open a document and or link to a study, I get a "Certificate Error" and when I click "Continue", I get an iStar login screen - Why?
 
A:  This will happen for studies and or documents that were saved/updated while the user was logged-in under the old domain: https://istar-chla.usc.edu. When you are updating studies, documents, etc. in the system, please make sure that you are logged into the new domain: https://istar.usc.edu; doing this will make it easier for anyone who might need to access your study in the future.
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Q:  I forgot my password. How do I reset it?
 
A:  Go to the iStar website and click the “forgot password” link below the login window. Follow the instructions to reset your password. You can also call the iStar help desk for assistance.
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Q:  How do I withdraw a study?
 
A:  First, login to iStar. Next, from your homepage, click the title of the study you want to withdraw. On the left side in the gray area under My Activities, click the Withdraw button. Note: You must be 100% sure that you want to withdraw it. Provide a reason in the pull down menu and description.
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Q:  I was added to the study by the “Edit Guest Access” button. I have read-only access, but I still don't see the study in my inbox, Why?
 
A:  A person that is given Read-Only access through the “Edit Guest Access” feature should have the corresponding “Guest” user role. To receive that user role contact the iStar help desk. Please note that this type of access is temporary. Investigators added to studies via this activity will lose their access once a study amendment is approved. See the following FAQ page topic under the General Section for instructions on how to obtain permanent access to study: "How do I obtain edit access to a study?"
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Q:  I am trying to submit an Amendment but I receive an error stating that “Not All Co-Investigators have agreed to participate”, what does that mean?
 
A:  In the Amendment application, you probably added new co-investigators, and they must click the “agree to participate” button before the amendment can be submitted. In the Amendment workspace, on the left side, click the “send co-investigator instructions” button under “My Activities”. By pressing this button, iStar will automatically email step by step instructions to the new co-investigators on how to agree to participate in the study. When all Co-Investigators agree, you may submit the amendment to IRB.
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Q:  I just received my iStar account and I need access to a study.
 
A:  Someone already listed in the study application (page 2) should create and submit an amendment application to give you access to the study.
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Q:  My email address has changed. How can I update my iStar account profile?
 
A:  You can update certain elements of your user profile such as your phone number or email address at any time by clicking on your name in the red banner area of the iStar website. Under the properties tab, select "Edit User Profile" from the drop-down list. At this point, the "Edit User Profile" page will load; after you update your information, make sure to click the "Apply" button to save your changes.
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Q:  I have moved to a different department. How can I update my iStar profile?
 
A:  Call or email the iStar help desk for assistance.
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Q:  How can I make a shortcut/bookmark to iStar?
 
 

Option 1: To mark the iStar site as a favorite in Internet Explorer, do the following:

  1. Navigate to the welcome screen of the iStar site by clicking the Home button in the gray bar above - located just below the red iStar banner.
  2. On the menu bar, select Favorites and then click Add to Favorites...
  3. In the Name field, type iStar System. Then click OK.

Option 2: To create a desktop shortcut in Windows, do the following:

  1. Right-click on any open space on your desktop.
  2. Select New and then Shortcut.
  3. In the new window, type https://istar.usc.edu into the location box.
  4. Click Next.
  5. On the next screen, type iStar System in the name box. Then click Finish.

Alternatively, you can also right-click on this link (https://istar.usc.edu) and select Copy Shortcut.  Then right-click in an open section of your desktop and select Paste Shortcut.  You can rename the shortcut to iStar System if desired.
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Q:  I would like to use the "Edit Study Personnel" activity in lieu of an amendment. How is this done? Are there any restrictions?
 
A:  The "Edit Study Personnel" activity can only be executed by the Principal Investigator, Study Contact Person or the Faculty Advisor. All personnel added this way must have a current Human Subjects (HS) training certificate and if it is a full board clinical trial study, they must also have a current Good Clinical Practice (GCP) training certificate. This activity will (not) be available if there is an open amendment on the study. You cannot use this activity to add a Principal Investigator, Co-Investigator or Faculty Advisor to your study (personnel listed as such can only be added/altered via an amendment). Please note that this activity will only be available to you while your study is in the APPROVED state.
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Q:  I have trouble opening up a PDF document in Chrome.  How can I fix this issue?
 

A:  Each browser has its own settings to control how PDFs open from a web page and Chrome defaults to use its own "Chrome PDF Viewer". 

To open PDFs with Adobe Reader within Chrome, go to chrome://plugins.  "Chrome PDF Viewer will be enabled and "Adobe Reader" plugin will be disabled.  If you "Enable" the Adobe Reader, the Chrome PDF Viewer will automatically be disabled.  Next to Adobe Reader, click the "Always Allowed" box.  Close the browser and reload the document.
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Q:  I forgot my CITI password, how can I get it?  Can I create another one?
 
A:  Please call CITI Help Desk at 213-821-5272.
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Q:  I took the CITI course and passed it, but I still did not receive an iStar account. 
 
A:  Even though you passed the CITI training course, it does not mean that you will receive an iStar account automatically.  You will still need to request an iStar account separately.
 Return to Section
 

Q:  I received my iStar account, but my password will not work when I try to login to the CITI website. 
 
A:  The iStar website and the CITI website are two different applications.  You will need to create a CITI account, which is separate from your iStar account.
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Q:  I am required to complete HIPAA training, but I cannot find the link to the USC HIPAA Online Education Course. 
 
A:  The HIPAA Online Education Course is taken through the USC Office of Compliance.  The following link will take you to their website: http://ooc.usc.edu/  Once you reach the website, you will need to click on HIPAA Privacy Education Program .
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Q:  Is my study a multi-site study (HSC and CHLA only)? 
 
A:  No. Multi-site research is research conducted by a sponsor at more than one institution (nationally and/or internationally) using the same protocol, each with its own Principal Investigator. Many clinical trials involving drugs/devices/biologics are conducted at more than one site.
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Q:  I cannot find my faculty advisor's name on iStar (item 2.6). What can I do? 
 
A:  Send a request to istar@usc.edu, asking for an iStar account to be created for your advisor. Provide your advisors name and email address, and also state that this person is a faculty advisor and needs the appropriate user role. Note that your advisor must complete CITI training and “approve” your IRB application through the iStar system before the IRB will review the application.
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Q:  Should my faculty advisor be listed in iStar as the PI or Co-PI and the faculty advisor? 
 
A:  If you are a student, postdoc fellow, or visiting professor, you must designate a faculty advisor in question 2.6. Designating your faculty advisor as the PI or Co-PI is dependent on your faculty advisor and/or the practices of associated school, division, department. Consult with your faculty advisor. Generally, we recommend that if it is the student’s project, the student should serve as the PI.
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Q:  Can I make changes to my iStar application once I've submitted it? 
 
A:  Once you’ve submitted the application, you are “locked out” of it. However, if any of the reviewers (i.e. faculty advisor, department/school, IRB staff) require you to make changes, the application will be sent back to you in an editable mode. Note that you may withdraw the application and start over by completing a new application. However, we don’t recommend this unless it absolutely necessary.
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Q:  How do I withdraw my iStar application? 
 
A:  You may withdraw the application by first clicking the study title from your homepage, and then the “withdraw” button on the lower left side of the screen.
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Q:  What are the required department approvals (screen 3 of the application) and do I need to obtain them? 
 
A:  For HSC and CHLA submissions, department approvals are required. iStar applications are automatically routed to these departments for approval. For UPC submissions, school/department approval is not required, and iStar automatically bypasses this process.
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Q:  I'm not sure if I need to report my funding source to the IRB. Must I? 
 
A:  In general, Yes. Especially for outside funding agencies, the source is required. However, do not report USC student grants unless they are specifically for research.
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Q:  Should the abstract be the same as scientific journal abstracts? 
 
A:  No, the abstract should be written in lay language and should have 1 or 2 sentences written to address each of the following points: background and rationale; objectives or purpose; study methodology; description of study arms (if appropriate); sample characteristics; study endpoints or outcomes; intervention and follow-up; statistics and plans for analysis.
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Q:  Is there an Informed Consent Form template available and do I have to use the template? 
 
A:  Yes, a template is available on the IRB website and you are required to use the template. Note that some items in the template are optional and should be included only when relevant to your study. Refer to the template for more information and instructions. Template forms are available on the IRB websites. Click the links below.

University Park: http://oprs.usc.edu/upirb/upirb-forms/
Health Sciences: http://oprs.usc.edu/hsirb/hsirb-forms/
 Return to Section
 

Q:  What if I receive correspondence that indicates I need to change the level of review from expedited to exempt? 
 
A:  To do this, login to iStar and click the study title. Next, click the “edit study” button from the study workspace. In question 4.1, change the level of review to “exempt” and click “next”. In question 4b, click one or more of the appropriate exempt categories. Make sure to click “save” before exiting the application. Note that you must return the application to the IRB by clicking one of the buttons under My Activities, such as “submit response to IRB staff” or “submit response to contingencies”.
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Q:  What if I receive correspondence that indicates my study is not human subjects research and I need to fill out the Not Human Subjects Research (NHSR) application? 
 
A: First, complete and submit the NHSR application. Once this is done, withdraw your original application. To complete the NHSR application, login to iStar and click the “NHSR?” button from your homepage, which is located on the bottom left of the screen. Note that you can copy and paste information (e.g. abstract, methodology, etc.) from your original application into the NHSR application. Once you submit your NHSR application, open the original application and click the withdraw button located under “My Activities”.
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Q:  What can I do to make the IRB review process smoother? 
 
A:  Make sure the study methodology is decided upon and well defined before submission. This means that the student and faculty advisor have agreed upon the design of the research. Note that an incomplete application is not reviewable and will be returned to you.
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Q:  I made a mistake and clicked OK on an activity when I didn’t mean to. 
 
A:  Once you click OK on an activity, there is not much that can be done. Please make sure you are truly ready to submit the application or response before clicking the OK button. If this happens, contact the help desk.
 Return to Section
 

Q:  My study is stuck and nothing is happening. 
 
A:  In the study workspace, look at the current state. Some stages of the review process (i.e. Divisional Review or Department Review) may take longer than others. If you think there is a problem, contact the help desk or the IRB Administrator assigned to your study.
 Return to Section
 

Q:  I cannot add a specific person to the study personnel. 
 
A:  In the study personnel screen of the application (screens 2a, 2b, and 2c), you must select the Principal Investigator, Study Coordinator, Co-Investigators, and other study staff who will have edit permissions to the study. When you click the Select or Add button for any of these questions, a person chooser window will open up.The person must have an iStar account for them to appear in the person chooser window.

If the person does not have an iStar account, have them obtain one by following the directions outlined in the Obtaining an iStar Account section of the website. Once they have obtained their account, their name will be listed in the person chooser window. You can then select it and add them to the study personnel.
 Return to Section
 

Q: I found the investigator's name in the "Add" pop-up window in section 2.1; however, when I attempt to save this person's information using the "OK and Add Another" button, the system will not add the name to the "Study Personnel" list. 
 
A:  The "Ok and Add Another" button located in the pop-up window in section 2.1 is not functional in the system. Go ahead and exit the application; once you re-enter the application, follow the steps below to add investigators to your study. If you still need assistance, please call the iStar Helpdesk:
  1. In section 2.1, click the "Add" button (a new pop-up window will open)
  2. In the "Staff Person" field, type-in the investigator's last name and a drop-down list should appear.
  3. Click the investigator's name from the list to select it.
  4. Choose a Study Role from the drop down menu that appears below the Staff Person field (i.e. Co-Investigator).
  5. In the next item, select "Yes" or "No" to indicate whether or not the investigator will be consenting subjects.
  6. Select a Study Access Level (if indicated).
  7. Once you have filled out all of the information, click the "Ok" button.

IMPORTANT: You must complete steps 1 through 7 for each investigator you wish to add to a study.
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Q:  How do I start a new study? 
 
A:  On your default folder page, at the left side you should see a button, New Study. Select that button and start filling out the questions.
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Q:  How can I start an Amendment? 
 
A:  Are you part of the study?
yes: You must be in the study and on the left hand side in gray area you should see a button New Amendment.
no: Someone in the study should add you to the study before you can start an Amendment.
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Q:  How do I withdraw a study? 
 
A:  Must be 100% sure you want to withdraw it! You must be in the study and on the left hand side in gray area under My Activities, you should see an option, Withdraw. You should choose the category and write a reason why you are withdrawing it.
 Return to Section
 

Q:  I was added to the study with Read-Only access under "Edit Guest Access", but I still don't see the study in my inbox, why? 
 
A:  A person that is added to Read-Only section, should have a Guest User role. To receive that user role, you should contact iStar Technical Support.
 Return to Section
 

Q:  I am trying to submit an Amendment but I receive an error stating that Not All Co-Investigators have agreed to participate, what does that mean? 
 
A:  That means that in the Amendment you have added new co-investigators and they have to agree to participate before you can submit this amendment. In the Amendment, on the left hand side in gray area under My Activities, you should have an option, "Send Co-Investigator Instructions". By pressing that option, an iStar will send all new co-investigators an email saying that they have to go to this amendment and "Agree to Participate in Study". When all Co-Investigators agree, you may Submit your Amendment to IRB.
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Q:  What is the status of my study? I have submitted my study two weeks ago and haven't heard from anyone.  
 
A:  You can check the status by clicking on "Studies:" on the black header under the yellow header. Click on the "All Studies" tab and find your study. Click on the study name and you will see the "Current State" of the study.
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Q:  I have a student volunteer from USC who will be working with me on a research project involving human subjects. How do I obtain an iSTAR account for this student? 
 
A:  The student should obtain an iSTAR account through USC. Please have them follow the instructions located in the Obtaining an iStar Account section.
 Return to Section
 

Q:  I have a student volunteer from a school other than USC who will be working with me on a research project involving human subjects. How do I obtain an iSTAR account for this student? 
 
A:  The student should log into CITI and complete certification in human subjects protection following the instructions for CHLA staff and faculty. The student should include (in his/her CITI profile) in the “employee number” field, the name of the staff or faculty at CHLA who will be responsible for the student’s research activities (“my supervisor is Dr. John Smith in Hem/Onc”)
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Q:  I will be collaborating with an investigator at another university or hospital. How can I obtain an iSTAR account for this collaborator?
 
A:  It is CCI policy not to provide iSTAR accounts for people not directly engaged in research activities at CHLA (consenting CHLA patients as subjects, conducting research procedures on CHLA subjects, etc…). To add individual outside collaborators not affiliated with CHLA, please check the box in item #1.4.1 in the iSTAR application. This will allow you to manually list outside collaborators (without iSTAR accounts) in your iSTAR application.
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Q:  What if my outside collaborator will be conducting research procedures with CHLA subjects?
 
A:  In this rare case, please contact the CHLA IRB office at (323) 361-2265 for guidance.
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Q:  What happens to my iSTAR account when I leave CHLA?
 
A:  When you terminate your affiliation with CHLA, your iSTAR account will be de-activated. Please contact the CHLA IRB office at (323) 361-2265 to let us know when you leave the institution.
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Q:  What will happen to the studies I am on when I leave CHLA?
 
A:  You (or another member of the research team) should either submit an amendment to remove you from the research team – or – submit a final report (continuing review application) to close the study. It is the responsibility of the research team on each iSTAR study to keep the study personnel listed in the approved iSTAR application current.
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