What is a “Protocol” deviation?

Deviation is a variance from the approved protocol procedures. Deviations specific to an individual subject are entered via the Protocol Console > Deviations tab entered via the Subject Console > Deviations tab.

What is a “Participant/Subject” deviation?

 Deviations specific to an individual subject are entered via the Subject Console > Deviations tab.

How to enter protocol deviations in OnCore:

1. Go to the CRA Console select the protocol and then the subject
2. Click the Deviations vertical tab and click the “New” button on the lower right.
   
   
3. Complete the fields “Under Subject Deviation”:
   1. Date Discovered: Enter the date the team became aware of the deviation. If multiple dates are applicable select the earliest date.
   1. Reported By: Enter the first and last name of the person who is reporting the deviation.
   1. Deviation Date: Enter the date when the deviation happened. Can be different from “Date Discovered”
   1. Category: From the drop down select the appropriate deviation categorization.
   1. Treating Physician: Enter the name of the physician
   1. Date reviewed by treating physician: Enter the date the treating physician reviewed the deviation.
   1. Description of Deviation: explain why it is a deviation. Be very precise as to dates and the decision-making processes that led to the deviation. Anyone reading the description should be able to understand the deviation without having to reference the protocol document.
   1. Effect on Patient Safety: Describe if the event affected or not affected the patient. This should be evaluated by the investigator.
   1. Action Taken: Describe if there were any action taken due to the deviation and any preventative actions taken.
   1.  Did the deviation put the participant or others at increased risk and/or negatively affect the primary study aims?: Check if applicable.
   1. Report to the IRB?: Select when the deviation needs to be reported.
   1. Date Reported to IRB: Enter the date the deviation was reported.
   1. Report to sponsor?: Check if the deviation needs to be reported to the sponsor.
   1. Date Reported to Sponsor: Enter the date the deviation was reported.
   1. Submit: Click once all of the information has been entered correctly.
   1. Print the PDF report
   1. Send it to PI to sign
   1. Save in regulatory binder (Subject/participant)
4. Complete the same information if “Protocol” deviation
   
   
5. How to print PDF for PI to sign
   1. PI Report Format: Once you have completed the deviation entry you can select a report type from the “PI Report Format”
   1. PI Report: Click this button to download the report.
   1. Subject Deviation PDF: Click this button to view the details.