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  • 1.  Are you able to change the expiration date via a Modification (HE)?

    RISING STAR CONTRIBUTOR
    Posted 02-12-2024 13:37

    Hello - Has anyone tested out the ability to update expiration dates via a Modification in Cayuse HE? The January 18 release notes included this change, but I recently tried and do not see any place to edit the expiration date in a Modification – only the Administrative Check In date. Is there something I am missing? Thanks!

     

     

    -- 

    Jennifer Boe, MA (she/her)

    Sr. IRB Analyst

    Human Research Protections Office (HRPO)

    Hennepin Healthcare Research Institute       



  • 2.  RE: Are you able to change the expiration date via a Modification (HE)?

    CAYUSE CHAMPION
    Posted 02-13-2024 07:04

    Hi Jenny,
    Thanks for bringing this up. Thought it was me looking at it incorrectly.



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    Amanda Hong
    IRB Coordinator
    Mount Sinai Hospital
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  • 3.  RE: Are you able to change the expiration date via a Modification (HE)?

    RISING STAR CONTRIBUTOR
    Posted 02-13-2024 07:54

    We also have had this issue, Jenny. I believe it may be possible to edit an expiration date if a study already has an expiration date, but I don't believe we can add an expiration date to a study that doesn't already have one.

    We were disappointed to see this as one of the main instances in which we'd want to edit an expiration date is to add it to a study that didn't already have one. 



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    Scott Fisher \
    Director, Human Research Protection Program
    New York University (NYU)
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  • 4.  RE: Are you able to change the expiration date via a Modification (HE)?

    RISING STAR CONTRIBUTOR
    Posted 02-13-2024 11:02

    Thanks to others for confirming! I can add that this study did already have an expiration date.

     

    -- 

    Jennifer Boe, MA (she/her)

    Sr. IRB Analyst

    Human Research Protections Office (HRPO)

    Hennepin Healthcare Research Institute

     






  • 5.  RE: Are you able to change the expiration date via a Modification (HE)?

    RISING STAR CONTRIBUTOR
    Posted 02-14-2024 08:28

    I received instructions from the ticket support that allowed me to change the expiration date (copied below). Apparently to edit an expiration date you must use Full Board review. I'm happy to have a way to edit the current study's expiration date but this is not an ideal workflow for our institution. We have a number of expedited studies that require continuing review (FDA regulated) and having to route something as Full Board isn't ideal in terms of record keeping – at a glance it looks like something went to the full board that did not.

     

    To remove or add an Admin Check In Date, you would need a modification with an Expedited review type, and route it to a reviewer. 
     
    Once it's in the reviewer's hands, there are two different options you can take. 
     
    Add an Admin Check In Date - To do this, you'd choose a date, and then select your decision and route it back. The analyst will then need to select a letter, and complete the post review. 
     
    Remove an Admin Check In Date - To do this, select the date text box, and delete the information in it. (Or, if there is nothing here, just leave it blank.) The Admin Check In Date is not a mandatory field. Select the decision next, and route it back to the Analyst. The analyst should then select the letter and complete post review for the Admin Check In date to update. (It will update to --) 
     
    To add or Remove the Expiration Date, you'll need a Full Board review, with the expedited option turned on. From here, steps are essentially the same as the steps taken to add or remove the Admin Check in Date. 
     

     

    -- 

    Jennifer Boe, MA (she/her)

    Sr. IRB Analyst

    Human Research Protections Office (HRPO)

    Hennepin Healthcare Research Institute