Page 386 - eBook Version 8 Book 1 of 2 JUL 2022

7. CHANGE HISTORY
Research Administration SOP No: R-Rec-101 SOP Title: Consent Process
SOP no.
Effective Date
Significant Changes
Previous SOP no.
R111
10/01/20
Provided clarification of 21CFR 11 requirements; Included reference to RA guidance and COVID command structure and the advisement to complete this process virtually whenever possible.
R111
R111
04/01/20
Added Adult Recruitment guidance and request form
R111
R111
09/01/20
Added more clarification of the ICF self- audit resources and documentation resources such as smart text in EPIC and the HIM email for scanning the ICF into the patient’s EMR.
R111
R-Rec-101
08/01/2022
Removal of COVID Restrictions and modifications
R111
Page 6 of 6