Reportable Event Submission Instructions for Studies or Projects That Are Not Active or Approved in ARROW
Occasionally, reportable events occur on studies that are not currently active or approved in ARROW, or for which an approved protocol never existed. For example:
- Noncompliance involving the conduct of research activities without an associated IRB application,
- Noncompliance for a study that is still undergoing IRB pre-review, or
- New information or noncompliance occurs on a study that is no longer active in ARROW (i.e. a study that has been archived), prohibiting any new submissions.