Header
PI Name
text
Protocol or IRB Number
integer
Protocol Short Title
Note To File
Applicability
boolean
RE
Written by
Date
date
Description of the issue/process/problem being documented , including (if applicable) how, when, and by whom the issue was identified, cause of issue (if known), corrective and preventive actions taken (when and by whom).
Description of related forms/documents
Author´s Signature
PI´s Signature