Accurately complete identification fields to ensure incident tracking, regulatory filing, and audit integrity. Mandatory fields are required for compliance.
Clinical Study Identifier
Protocol Number
Trial Phase
Phase I (First-in-Human)
Phase II (Therapeutic Exploratory)
Phase III (Therapeutic Confirmatory)
Phase IV (Post-Marketing)
Observational/Epidemiological
Expanded Access/Compassionate Use
Bioequivalence/BA Study
Trial Site Name
Trial Site Number (as per contract)
Site Physical Address and Department
Reporting Clinical Research Associate (CRA) Full Name
CRA Employee ID or Credential Number
CRA Professional Email Address
CRA Direct Business Contact Number
Date and Time of Deviation Discovery (local time)
Date and Time of Original Consent Procedure (as documented)
Scheduled Protocol Visit Number / Name
Participant Study ID (Masked Identifier)
Participant Initials (per site SOP and privacy policy)
Participant Date of Birth
Participant Age at Time of Consent (years)
Participant Gender (as recorded)
Male
Female
Non-binary
Prefer not to say
Other:
Consent Process Context
In-Person at Site
Remote via Telemedicine
Remote via Phone (with waiver)
Home Visit
LAR/Proxy in-Person
Other
Person Who Obtained Consent (Name and Role)
Duration of Consent Process (minutes)
Was a Witness Present During Consent?
Witness Name and Role
Classify the deviation precisely and conduct thorough root cause analysis. This information drives corrective action effectiveness and regulatory reporting decisions.
Primary Deviation Category
Missing Signature - Participant
Missing Signature - Investigator
Missing Signature - Witness
Missing Date - Participant
Missing Date - Investigator
Missing Date - Witness
Incorrect ICF Version Used
Missing Page(s) from ICF
Incomplete Initials on ICF Pages
Consent Obtained by Unauthorized Study Staff
Consent Obtained Outside Protocol Time Window
Legally Authorized Representative (LAR) Consent Issue
Translation/Interpretation Service Issue
Assent Not Obtained from Minor (when required)
Re-consent Not Obtained for Protocol Amendment
Withdrawal of Consent Not Properly Documented
Documentation of Consent Discussion Inadequate
Other Critical Deviation
Detailed Deviation Description
Consent Form Page-by-Page Verification
Page Number | Present in Documentation? | Participant Initials Present? | Investigator Initials Present? | Issues Identified | ||
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Correct ICF Version Number and Date
Incorrect ICF Version Used (if applicable)
Deviation Discovery Timing
During Real-Time Consent Process
Within 24 Hours Post-Consent
During Source Data Verification (SDV)
During Remote Monitoring Review
During On-Site Monitoring Visit
During Internal Audit
During Regulatory Inspection
During Data Management Review
During Quality Assurance Review
Other
Root Cause Category (select all that apply)
Human Error - Knowledge Gap
Human Error - Attention/Focus
Human Error - Communication
Process Design Flaw
Standard Operating Procedure (SOP) Deficiency
Training Program Inadequacy
Technology/System Failure
Resource/Staffing Constraint
Version Control System Failure
Time Pressure/High Workload
Environmental Distraction
Inadequate Supervision/Oversight
Other
Detailed Root Cause Analysis Narrative
Contributing Factors (select all applicable)
High Enrollment Volume/Pressure
Study Coordinator Turnover
Inadequate Delegation of Authority Log
Ambiguous or Complex Protocol Requirements
Participant Vulnerability (cognitive, language, emotional)
Language/Translation Barrier
Technical Issues with Electronic Systems
Remote/Telemedicine Consent Process
Pandemic/Disruption Impact
Inadequate Site Initiation/Training
Quality Management System Gap
None of the Above
Other
Repeat Deviation for This Participant?
Describe Previous Deviation(s) and Failed Corrective Actions
Systemic Issue Potentially Affecting Multiple Participants?
Estimated Scope: Number of Potentially Affected Participants
Documentation Gap Analysis
Immediate Corrective Actions Taken
Proposed Preventive Actions and Process Improvements
Comprehensive assessment of participant impact across safety, privacy, and ethical dimensions. This evaluation determines protection measures and ongoing participation appropriateness.
Direct Impact on Participant Physical Safety or Clinical Care?
Safety Impact Details and Immediate Remediation
Privacy or Confidentiality Breach Occurred?
Breach Type (select all applicable)
Unauthorized Access to Protected Health Information
Improper Disclosure to Third Party
Inadequate Authorization for Information Release
Missing De-identification of Data
Breach of Assent/Consent Process for Minors
Inadequate Privacy Safeguard Implementation
Other
Breach Scope and Affected Data Description
Risk Assessment Matrix (Rate each dimension 1-5)
Participant Safety Risk | |
Privacy/Confidentiality Risk | |
Data Integrity Risk | |
Regulatory Compliance Risk | |
Protocol Deviation Severity | |
Reputational Risk to Institution |
Overall Impact on Continued Trial Participation
No Impact - Participant Fully Eligible
Minor Impact - Standard Monitoring Sufficient
Moderate Impact - Enhanced Monitoring Required
Significant Impact - Additional Protections Needed
Severe Impact - Eligibility Under IRB Review
Critical Impact - Discontinuation Recommended
Unable to Assess - Pending Further Information
Re-consent or Re-confirmation Required?
Scheduled Re-consent Date/Time
Participant Notified of Deviation?
Notification Date/Time
Justification for Delayed Notification
If Notified, Does Participant Wish to Continue?
Document continued participation in source and obtain written acknowledgment if required by SOP.
Document Withdrawal Process and Final Visit Requirements
Risk Mitigation and Participant Protection Measures Implemented
Determine and document all reporting obligations to ethics committees and regulatory agencies. Ensure compliance with jurisdictional requirements and institutional policies.
IRB/Ethics Committee Reporting Required?
IRB Reporting Timeline
Immediate (within 24 hours)
Prompt (within 5 business days)
Expedited (within 10 business days)
Standard (next continuing review)
Emergency (immediate phone + written follow-up)
As per IRB SOP guidance
Planned IRB Submission Date/Time
Regulatory Authority Notification Required?
Authorities to Notify (select all applicable)
National Competent Authority (e.g., FDA, EMA)
Food and Drug Administration (FDA) - USA
European Medicines Agency (EMA) - EU
Medicines and Healthcare Products Regulatory Agency (MHRA) - UK
Health Canada - Canada
Therapeutic Goods Administration (TGA) - Australia
Pharmaceuticals and Medical Devices Agency (PMDA) - Japan
National Medical Products Administration (NMPA) - China
Data Protection Authority (GDPR/privacy breach)
Office for Human Research Protections (OHRP)
Institutional Legal/Risk Management
Study Sponsor Regulatory Affairs
Other Authority
Regulatory Reporting Justification and Legal Basis
Deviation Severity Classification for Reporting Purposes
Minor Protocol Deviation (non-reportable)
Major Protocol Deviation (reportable)
Serious Breach of Good Clinical Practice
Serious Breach of Protocol
Safety Reportable Event
Privacy/Data Protection Breach
Urgent Safety Measure
Other
Regulatory Notification Deadline (if applicable)
Notification Plan and Status Tracker
Authority Name | Planned Submission Date/Time | Responsible Person | Submitted? | Actual Submission Date/Time | ||
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Notification Package Documents (check all included)
Deviation Incident Report
Corrective and Preventive Action (CAPA) Plan
Participant Notification Letter (if applicable)
Root Cause Analysis Documentation
Updated ICF Version (if re-consent needed)
Site SOP Revisions
Training Records/Plan
Risk Assessment
PI Assessment Statement
QA Review Findings
Other
Will This Be Reported in Development Safety Update Report (DSUR)?
DSUR Narrative Summary and Section Placement
Post-Notification Follow-up and Monitoring Plan
Final review, risk determination, and formal attestation by clinical and quality leadership. This section confirms appropriate incident management and regulatory compliance.
Principal Investigator Full Legal Name
Principal Investigator Medical License/Credential Number
Principal Investigator Institutional Affiliation
PI Review and Assessment Date/Time
PI Assessment of Impact on Participant Rights, Safety, and Well-being
No Impact - No action required
Minimal Impact - Resolved with documentation
Mild Impact - Monitoring recommended
Moderate Impact - Enhanced monitoring required
Significant Impact - Additional protections implemented
Severe Impact - Discontinuation under consideration
Critical Impact - Immediate action required
PI Detailed Assessment and Medical Judgment
PI Recommendation for Participant Continuation in Study
Continue Participation - No Changes
Continue with Standard Monitoring
Continue with Enhanced Monitoring
Continue with Additional Safeguards/Protections
Temporary Hold - Pending Re-consent
Discontinue from Study - Voluntary Withdrawal
Discontinue from Study - PI Determination
Refer to IRB for Eligibility Determination
Clinical Quality Assurance Lead Full Name
QA Lead Professional Title and Credential
QA Review and Audit Date/Time
QA Final Risk Classification (1=Low Risk, 5=Critical Risk)
QA Review Findings and Determinations (select all applicable)
Report Complete and Accurate
Root Cause Analysis Adequate
Corrective Actions Appropriate and Timely
Preventive Actions Sufficient and Robust
Reporting Timeline Compliant with Regulations
Training Plan Adequate
SOP Revision Required and Documented
Process Improvement Opportunities Identified
No Systemic Issues - Isolated Incident
Systemic Issue Requiring Site-Level Action
Escalation to Sponsor Required
Escalation to Institutional Leadership Required
Legal/Risk Management Consultation Needed
Incident Ready for Closure
Incident Requires Further Investigation
QA Comprehensive Review Comments and Quality Improvement Recommendations
I attest that I have reviewed this incident report in its entirety and agree with the findings and assessments documented herein.
I confirm that all regulatory reporting obligations have been identified and will be completed within required timelines.
I acknowledge that false or misleading information in this report may constitute regulatory non-compliance.
Principal Investigator Signature
Clinical Quality Assurance Lead Signature
Report Final Tracking/Archive Number
Incident Closed?
Official Closure Date
Outstanding Actions and Target Resolution Date
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