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

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Presentation transcript:

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 Study The 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 Study The 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 Study The 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 Study The 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 Study The 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 Closure The 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 Closure The 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 modification The following are the questions you will be asked to complete.

The following are the questions you will be asked to complete. Submit a modification The following are the questions you will be asked to complete. Be sure not to select the first 4 boxes or the study will be closed.

Submit a modification The 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 Information The following are the questions you will be asked to complete.

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

Report New Information The 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 the submission 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