Review History Prep Checklist

IRB#______Date:______
/ N/A / DISCOVR-E/LN Review History Preparation
  1. Have you created a Review History to remove item from inbox?

  1. Have you completed the appropriate information on the submission page, i.e., if an amendment with KSP updates have you updated the amendment page to reflect appropriate information with the radio buttons and the Detailed Description Section?

  1. If a CR, is PI’s training current? If not, approve the submission pending completion of PI training.

  1. Have you reviewed the items in DISCOVR-E and determined whether a pre-review is required?

  1. If pre-review step complete or not needed, have you loaded documents into appropriate buckets within the review history? (Note, see activity book for guidance)

  1. Have you indicated review type?

  1. Have you assigned an expedited reviewer?

  1. Have you either clicked the “Notify Reviewer” button or entered the “Sent for Review” Date as applicable?

  1. Have you entered a date for the “Pre-review Ended” date?

  1. Have you created your letter for Chair/Vice Chair if applicable?

  1. Have you selected your documents to stage for publishing and moved them down into the “Documents Ready for Approval/Publish” area as applicable?

  1. Are documents named appropriately in publish region? If not, have you renamed as applicable?

  1. Have tracked versions been saved in publish region as clean?

  1. Create letter, then save and close Review History.

LETTER
  1. Is you detailed description complete and are document dates included in the letter based on current activity book guidance?

  1. Is letter generally correct and information regarding consent procedures appropriately updated?

  1. Does CMS notification appear in FAL? If so, is template language in the FAL regarding CMS approval? Please note: If new CMS study, ICD’s are not released with original approval letter. See Activity Book for additional information.

  1. Are approval/expiration dates appropriate as applicable

  1. Are initials entered appropriately?

  1. Have you entered the name as appropriate in the “Verify By” field?

  1. Have you changed the letter status to “Pending Review”?

  1. Save and Close the letter.

  1. Did letter fall into the Assigned Letters View for Chair/Vice Chair signature as appropriate?

Main Page
  1. Is PI and Study Contact information updated? (Please note, KSP table should be updated appropriately to ensure anyone listed on study can see information in DISCOVR-E)

  1. Also, if KSP update, hasKSP change been made and PHI boxes been updated appropriately on KSP table on main page? KSP table removed from IRB Application, if applicable.

  1. Is last approval date correct?

  1. If a New Standard/Expedited or Major Amendment, is Medicare/NCT information complete and has Medicare form been loaded onto the main page?

  1. Is “funding received” checkbox correctly marked?

E-File
  1. If a pre-review has been completed has the pre-review been closed out in DISCOVR-E?

  1. Is everything right with the world? Sorry, I couldn’t help myself.

4/22/2013