For researchers, the key take-aways from the E-IRB system update that occurred on March 24, 2023 are summarized below:


Deviation/Exception - Single Use Informed Consent Form (ICF)


A new ‘document type’ (DocType) has been added to the options for uploading in the Deviation/Exception Request Form called “Single-Use ICF”.  

When this DocType is assigned to an attachment, upon approval of the Deviation or Exception, the informed consent form (ICF) gets a stamp with the words “Single Use” in it.

The stamped ICF is included in the file that opens when the user clicks the “View # ___” link for the applicable Deviation/Exception under the Completed Other Reviews tab in Protocol History.

 

New Attachments


The following improvement was made for consistency in reflecting when an edit has been made:

 

  • New attachments are now indicated by a gold row (instead of red-colored font).

All Attachments and 'Download All' Tool


“All Attachments” is the recommended place to view materials to be considered for IRB review/approval in an “In-Progress” application. Researchers should keep this in mind when tasked with removal of outdated documents as the documents may not appear within the section itself.



For example:

 

The ‘Download All’ tool now also generates a .csv file listing all the attachments in the zip folder with the following info:


  • the name of each file (i.e., the E-IRB generated file name);
  • the original file name (i.e., the name the file had when the researcher uploaded it);
  • the description entered by the researcher;
  • relevant dates;
  • ID of uploader.

 

 As always, we hope the latest update improves your overall E-IRB experience!