Using ERA-IRB

How to submit new IRB applications, continuing reviews, and modifications using ASU’s new online submission system

About ERA-IRB

• You will use ERA-IRB to submit all new IRB protocols, continuing reviews/close outs, and modifications by entering information into online forms.

• You can have all your materials prepared and then load them into the system.

Accessing the System

Access ERA-IRB from the Office for Research Integrity & Assurance website:http://researchintegrity.asu.edu/humans

Log in using your ASURITE User ID & Password.

Create a New Study

• To initiate a new Social Behavioral or Bioscience application, start at My Inbox and click “Create New Study.”• Applications and supplemental materials are accepted at any time.• You can have all materials prepared and then load into the system.• You can save your application in progress to come back in and complete your

application at a later time

Create a New StudyThe following are the questions you will be asked to complete.

• The software will automatically guide you through the process of completing the application forms based on the information you enter.

• All required fields must be filled in.

Create a New StudyThe following are the questions you will be asked to complete.

• A later section of the form directs you to add Student Study Team Members.

Create a New StudyThe following are the questions you will be asked to complete.

Depending on your study, you may also need to submit documents such as:

• Recruitment Materials• Copies of all survey and

interview questions,• Copies of all documents in English

• Other language(s) and certification of translation later

• Fee – if the project is sponsored by private industry or will be submitted to WIRB

Create a New StudyThe following are the questions you will be asked to complete.

To add a study team member, you will need to have their ASURITE ID .

Create a New StudyThe following are the questions you will be asked to complete.

• Once the application is complete, only the Principal Investigator may submit the application. However, the PI can designate a study contact who can respond to IRB inquiries.

Submit the Study

• To submit, click “Submit” from the My Current Actions list on the left.

Submit a Continuing Review/Study Closure

• To submit a Continuing Review or Close your study, from IRB Records, select the Active tab.

• Continuing and Closure Actions are appropriate for studies that were approved by expedited or full board review.

Submit a Continuing Review or Study Closure

• Select the study by clicking on the study name. • Click Create Modification/CR

Submit a Continuing Review / Study ClosureThe following are the questions you will be asked to complete.

For studies that are active you will need to submit a progress report. If enrollment continues you will need to submit a copy of the unstamped consent forms.

Submit a Continuing Review / Study ClosureThe following are the questions you will be asked to complete.

Submit a Modification

• To submit a Modification, you will follow the same process as submitting a Continuing Review:• From IRB Records, select the Active tab. • This is to be done for studies approved through expedited or full board

review.

Submit a Modification

• Select the study by clicking on the study name. • Click Create Modification/CR

Submit a modificationThe following are the questions you will be asked to complete.

Submit a modificationThe following are the questions you will be asked to complete.

Be sure not to select the first 4 boxes or the study will beclosed.

Submit a modificationThe following are the questions you will be asked to complete.

Report New Information

• To Report New Information:• From IRB Records, select the Active tab.

Report New Information

• Click on the name of the study. • Click Report New Information (RNI)

Report New InformationThe following are the questions you will be asked to complete.

Report New InformationThe following are the questions you will be asked to complete.

Report New InformationThe following are the questions you will be asked to complete.

For more help

• Once you are logged into ERA-IRB, you can access additional help on using ERA-IRB under the Help menu or by contacting ORIA at research.integrity@asu.edu.

Contact Information

ORIA staff are available to answer questions and assist you with thesubmission process.• Susan Metosky, Assistant Director

– Susan.Metosky@asu.edu (480) 727-0871

• Tiffany Dunning – Tiffany.Dunning@asu.edu (480) 639-7396

• David Marin – David.Marin@asu.edu (480) 965-4796

• Debra Murphy, Director – Debra.Murphy@asu.edu (480) 965-2179

Research.integrity@asu.edu