This section captures essential trial and participant identification information to ensure proper tracking and reporting of the protocol deviation.
Protocol Number
Protocol Title
Protocol Version Number
Investigational Product(s)
Study Sponsor
Study Phase
Phase I
Phase II
Phase III
Phase IV
Observational
Expanded Access
Not Applicable
Study Site Name
Study Site Identifier
Subject ID Number
Subject Initials (for verification)
Subject Enrollment Date
Visit Number
Visit Type
Screening
Baseline
Treatment/Intervention
Follow-up
Early Termination
Unscheduled
Other
Scheduled Visit Date
Date and Time of Deviation Occurrence
Date and Time Deviation Was Identified
Name of Person Reporting Deviation
Role of Reporting Person
Principal Investigator
Sub-Investigator
Study Coordinator
Research Nurse
Pharmacist
Laboratory Staff
Monitor
Auditor
Data Manager
Other Clinical Staff
Was this deviation identified during a monitoring visit?
Was this deviation discovered during an internal or external audit?
Is this considered an urgent safety issue requiring immediate escalation?
Provide comprehensive details about the protocol deviation including classification, description, and supporting evidence. This information is critical for proper risk assessment and regulatory compliance.
Primary Deviation Category
Informed Consent Process
Eligibility Criteria
Study Drug/Investigational Product Administration
Study Procedure/Assessment
Visit Schedule/Timing
Laboratory Sample Collection/Handling
Concomitant Medication
Adverse Event Reporting
Protocol Amendment Implementation
Documentation/Record Keeping
Device/Equipment Use
Patient Withdrawal/Discontinuation
Confidentiality/Privacy Breach
Other
Secondary Deviation Categories (if applicable)
Informed Consent Process
Eligibility Criteria
Study Drug/Investigational Product Administration
Study Procedure/Assessment
Visit Schedule/Timing
Laboratory Sample Collection/Handling
Concomitant Medication
Adverse Event Reporting
Protocol Amendment Implementation
Documentation/Record Keeping
Device/Equipment Use
Patient Withdrawal/Discontinuation
Confidentiality/Privacy Breach
Detailed Description of Deviation
Root Cause Analysis
GCP Principles Potentially Violated (select all that apply)
Subject safety and well-being
Informed consent process
Protocol compliance
Data integrity and accuracy
Investigational product accountability
Confidentiality/privacy
Regulatory compliance
None identified
Is this a repeated deviation for this subject?
Is this a new type of deviation for this site?
Deviation Severity Classification
Minor
Moderate
Major
Critical
Does this deviation constitute a protocol violation (more serious than a deviation)?
Was a protocol amendment required to address this issue?
Supporting Documentation Required (check all that apply)
Source document worksheets
Medical records
Photographs
Laboratory reports
Pharmacy records
Training records
Communication logs
None required
Related Deviations (if this is part of a pattern)
Related Deviation ID | Date of Related Deviation | Category | Brief Description | Resolution Status | |
|---|---|---|---|---|---|
Document all corrective actions taken immediately upon discovery of the deviation to mitigate any potential impact on subject safety and data integrity.
Immediate Corrective Actions Taken
Person Who Took Corrective Action
Date and Time Corrective Action Initiated
Date and Time Corrective Action Completed
Was the subject notified of the deviation?
Was the subject's legally authorized representative notified?
Was protocol-specific re-training conducted for study staff?
Was the study drug/Investigational Product adjusted or modified?
Were additional safety assessments ordered?
Was the subject withdrawn from the study?
Will these corrective actions prevent recurrence?
Corrective Action Tracking
Action Item | Responsible Person | Target Completion Date | Actual Completion Date | Completed? | Verification Method | |
|---|---|---|---|---|---|---|
Conduct a thorough assessment of the deviation's impact on patient safety and data integrity. This assessment will determine reporting requirements and risk mitigation strategies.
Impact on Patient Safety
No impact
Minimal impact
Moderate impact
Severe impact
Life-threatening impact
Unknown
Patient Safety Impact Explanation
Impact on Data Integrity
No impact
Minimal impact
Moderate impact
Severe impact
Critical impact
Unknown
Data Integrity Impact Explanation
Does this deviation affect the primary endpoint analysis?
Does this deviation affect any secondary endpoints?
Does this deviation affect safety data reporting?
Does this deviation affect pharmacokinetic/pharmacodynamic data?
Will data from this subject be excluded from analysis?
Detailed Risk Assessment Matrix
Likelihood of recurrence | |
Detection difficulty | |
Patient safety risk | |
Primary endpoint impact | |
Secondary endpoint impact | |
Safety data impact | |
Regulatory compliance risk |
Was this deviation preventable?
Was an Adverse Event (AE) or Serious Adverse Event (SAE) reported in relation to this deviation?
Overall Risk Assessment Summary
This section documents Principal Investigator review, assessment, and all regulatory notifications including IRB and regulatory authority submissions as required by the impact assessment.
Date and Time PI Notified
Principal Investigator Assessment and Comments
Does PI agree with the severity classification?
Principal Investigator Digital Signature
PI Signature Date
Is IRB notification required for this deviation?
Has IRB notification been submitted?
Has IRB response been received?
Is regulatory authority notification required?
Has regulatory authority notification been submitted?
Has sponsor been notified?
Final Disposition Status
Open - Under Investigation
Open - Awaiting IRB Response
Closed - Corrective Action Complete
Closed - No Action Required
Closed - Subject Withdrawn
Escalated - Regulatory Filing Required
Site Coordinator/Designee Final Sign-Off
Final Sign-Off Date
Additional Comments and Notes
Notification Tracking Log
Notification Type | Notification Date/Time | Recipient | Method | Acknowledgment Received? | Reference Number | |
|---|---|---|---|---|---|---|