Recording and Reporting Deviations

Subject Level Deviations

1. Begin on Home page > Subjects menu > CRA Console

2. Select the Protocol by entering the protocol number in the "Select Protocol" field

3. Select the Subject by entering the subject name in the "Select Subject" field or click on the Epic MRN link in the Accrual Details box

4. Click the Deviations vertical tab

5. Click "New"

6. Enter the following "Required Fields" into the "Subject Deviation Create" block:

   1. Date Discovered

      1. The date the deviation was discovered. The current date auto-populates in this field, but may be edited

   2. Deviation Date

      1. Indicates the date deviation occurred or began

   3. Category

      1. A description of the event with options of: Consent, Eligibility, HIPAA, Other, Scheduled Procedure, Treatment

   4. Treating Physician

      1. Physician in charge of the patient's treatment

      Open

      

7. Click "Submit" and "Close"

8. Below the Subject Deviation Inquiry block, click "PI Report" to generate report of deviations for PI assessment and approval

9. Obtain PI Assessment of Deviations Report

   1. If Deviation Report DID require PI edits:

      1. Begin on Home page> Subjects menu > CRA Console

      2. Select the Protocol by entering the protocol number in the "Select Protocol" field

      3. Select the Subject by entering the subject name in the "Select Subject" field or click on the Epic MRN link in the Accrual Details box

      4. Click the Deviations vertical tab

      5. In "Subject Deviation Details" block click the blue date link of the deviation you need to update

      6. Click "Update" and update with any new information/PI assessment

      7. Click "Submit" and "Close"

      8. Below the Subject Deviation Inquiry block, click "PI Report" to generate report of deviations for PI assessment and approval

      9. Obtain PI Assessment of Deviations Report

   2. If a Deviation Report did NOT require PI edits:

      1. Begin on Home page > Subjects menu > CRA Console

      2. Select the Protocol by entering the protocol number in the "Select Protocol" field

      3. Select the Subject by entering the subject name in the "Select Subject" field or click on the Epic MRN link in the Accrual Details box

      4. Click the Deviations vertical tab

      5. In the "Subjects Deviation Details" block, click the blue date link of the deviation you are updating

      6. Click "Update" and update with PI responses to safety/validity questions. Ensure deviation information is complete.

      7. Click "Submit" and "Close"
         

10. The Regulatory Coordinator should complete the Deviation Record according to the instructions on the "Updating Regulatory Reportable Event Information" Work Instructions.

Protocol Level Deviations

1. Begin on Home page > Protocols menu > PC Console

2. Select the Protocol by entering the protocol number in the "Select Protocol" field

3. Click the Deviations vertical tab

4. In the "Protocol Deviations Overview" block, click "New Protocol Deviation"
   

5. Enter the following "Required Fields" into the "Protocol Deviation Create" block:

   1. Date Discovered

      1. The date the deviation was discovered. The current date auto-populates in this field, but may be edited

   2. Deviation Date

      1. Indicates the date deviation occurred or began

   3. Category

      1. A description of the event with options of: Consent, Eligibility, HIPAA, Other, Scheduled Procedure, Treatment

      Open

      

6. Click "Submit" and "Close"

7. Below the "Protocol Deviation Inquiry" block, click "PI Report" to generate report for PI assessment and approval

8. Obtain PI assessment of Deviation Report

   1. If Deviation Report DID require PI edits:

      1. Begin on Home page > Protocols menu > PC Console

      2. Select the Protocol by entering the protocol number in the "Select Protocol" field

      3. Click the Deviations vertical tab

      4. In "Protocol Deviation Details" block, click the blue "Date Discovered" link of the deviation you are updating

      5. Click "Update" and update with any new information/PI assessment

      6. Click "Submit" and "Close"

      7. Obtain PI assessment of Deviation Report

   2. If Deviation Report did NOT require PI edits:

      1. Begin on Home page > Protocols menu > PC Console

      2. Select the Protocol by entering the protocol number in the "Select Protocol" field

      3. Click the Deviations vertical tab

      4. In the "Protocol Deviation Details" block, click on the blue "Date Discovered" link of the deviation you are updating

      5. Click "Update" and update with any new information/PI response to safety /validity questions. Ensure deviation information is complete

      6. Click "Submit" and "Close"

9. The Regulatory Coordinator should complete the Deviation Record according to the instructions on the "Updating Regulatory Reportable Event Information" Work Instruction
   Instructions on how to send out the subject deviation notice can be found here

*Institutional required fields marked in red, bold font