Background

When performing the Submit Designated Review activity, it is required to select a review level (Exempt or Expedited) and then all applicable categories (e.g., (2)(a) Blood samples from healthy, non-pregnant adults, (mm) Minor modification). 

There have been cases where after the Submission has already been approved, ORIS is asked to correct review level category(ies).

Step-by-Step Guide

1. Send request to irbadmin@psu.edu for the CATS team to update the review level category(ies).
   

   Technical Analyst Needed Open the Command Console script ChangeExemptDeterminations OR ChangeExpeditedDeterminations    Set the studyID value equal to the Submission that needs updated Set the isDeleted value to True or False depending on if you are adding a new Determination or deleting an existing Determination Set the determination value to the determination to add or remove Run the script  In the case a determination is being replaced, the script will need to be run twice:  once to delete the existing determination and once to add the new determination

   
   
   
2. Add a Private Comment which can look something like "Per HRPP request, the Expedited Determination was administratively updated from (mm) Minor modification to (8)(b) No subjects enrolled (CATS Reference INC2395066)"
   
   
3. Provide follow-up to the individual who made the request.

Related Incident Example(s)

INC2395066 - (Dec. 2023) CR00020408 expedited review category updated & KB created.

INC2429789 - (Jan. 2024) CR00022135 expedited review category updated & ChangeExpeditedDeterminations script updated to more deliberately change all needed fields (all changes were re-confirmed to have been updated for CR00020408, but the deliberate changes were needed for this protocol and should make the script more robust moving forward).