ACTRIS – scenario 2, eCRF review shows protocol deviation
The monitor, during remote eCRF review (as per the Monitoring Plan) flags a (potential) protocol deviation. She/he phones with site staff to ask for clarity, and obtains conformation. Sadly, this is not an isolated case. This particular site is not organized very well.
After having collected the necessary information*, a new issue is created in ACTRIS, set to priority ‘medium’ and to risk type ‘Project Risk – Data Validity’, and assigned to the PM. The issue is linked to previous issues identified at this site.
In the Remote Monitoring Report, this particular issue flagged is reported by using the hyperlink to its ACTRIS issue. This way, action items will be kept separate, yet integrated (eventually), avoiding duplication of efforts. Follow-up to the issue will be given to the issue itself, within the timelines specified for ‘medium’ priority risks. There is no need to use e-mail when it gets to informing all in the team. The report reviewer will have a timely view on the issue at the moment of review**, by clicking on the link.
*including a screenshot from the eCRF, and any other details to assist in the analysis of this deviation
**it can be commented on, resolved and closed. It can easily be filtered out of all issues on ACTRIS, taken for training purposes, for collection onto Protocol Deviation Logs, etc.
See next page.