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:
- Go to the CRA Console select the protocol and then the subject
- Click the Deviations vertical tab and click the “New” button on the lower right.
- Complete the fields “Under Subject Deviation”:
- Date Discovered: Enter the date the team became aware of the deviation. If multiple dates are applicable select the earliest date.
- Reported By: Enter the first and last name of the person who is reporting the deviation.
- Deviation Date: Enter the date when the deviation happened. Can be different from “Date Discovered”
- Category: From the drop down select the appropriate deviation categorization.
- Treating Physician: Enter the name of the physician
- Date reviewed by treating physician: Enter the date the treating physician reviewed the deviation.
- 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.
- Effect on Patient Safety: Describe if the event affected or not affected the patient. This should be evaluated by the investigator.
- Action Taken: Describe if there were any action taken due to the deviation and any preventative actions taken.
- Did the deviation put the participant or others at increased risk and/or negatively affect the primary study aims?: Check if applicable.
- Report to the IRB?: Select when the deviation needs to be reported.
- Date Reported to IRB: Enter the date the deviation was reported.
- Report to sponsor?: Check if the deviation needs to be reported to the sponsor.
- Date Reported to Sponsor: Enter the date the deviation was reported.
- Submit: Click once all of the information has been entered correctly.
- Print the PDF report
- Send it to PI to sign
- Save in regulatory binder (Subject/participant)
- Complete the same information if “Protocol” deviation
- How to print PDF for PI to sign
- PI Report Format: Once you have completed the deviation entry you can select a report type from the “PI Report Format”
- PI Report: Click this button to download the report.
- Subject Deviation PDF: Click this button to view the details.