This section captures essential identification metadata for trial accountability and device traceability. Accurate completion ensures proper root cause analysis and regulatory correspondence.
Clinical Trial Protocol Number
Trial Phase
Phase I
Phase II
Phase III
Phase IV
Pilot/Feasibility
Expanded Access/Compassionate Use
Trial Indication or Disease Area
Sponsor Organization Name
Contract Research Organization (CRO) Name (if applicable)
Clinical Site Identifier
Clinical Site Full Address
Site Principal Contact Email
Site Principal Contact Phone
Subject Identifier (Patient ID)
Subject Initials
Subject Date of Birth
Subject Gender
Male
Female
Other
Not Specified
Subject Enrollment Date in Trial
Device Product Name
Device Model Number
Device Catalog or Part Number
Device Lot Number
Device Serial Number
Firmware or Software Version
Device Manufacturer Name
Device Risk Classification
Class I (Low Risk)
Class IIa (Medium Risk)
Class IIb (Medium-High Risk)
Class III (High Risk)
Active Implantable
Not Classified
Date and Time of Incident Occurrence
Date and Time Incident Was Discovered
Name of Person Who Discovered Incident
Role of Discovering Person
Principal Investigator
Sub-Investigator
Study Coordinator
Research Nurse
Biomedical Engineer
Clinical Monitor
Patient/Subject
Other Site Personnel
Date of Last Known Normal Device Function
Provide a comprehensive, objective narrative of the incident including sequence of events, clinical consequences, and immediate actions taken. This section forms the core of the medical and technical evaluation.
Detailed Event Description and Sequence of Events
Chronological Event Timeline
Time | Action or Observation | Responsible Person or System | Critical Milestone? | |
|---|---|---|---|---|
8:30 AM | Device activation for morning calibration | Biomedical Engineer | ||
9:15 AM | Abnormal reading first observed | Research Nurse | ||
9:20 AM | Device removed from patient | Sub-Investigator | ||
Did this incident result in patient harm, injury, or clinical consequence?
Patient Harm Severity Grade
Grade 0 - No Harm
Grade 1 - Mild (transient, no intervention)
Grade 2 - Moderate (minimal intervention)
Grade 3 - Severe (permanent damage)
Grade 4 - Life-threatening or disabling
Grade 5 - Death
Causality Assessment (Probability of Cause-Effect Relationship)
Not Related | Unlikely | Possible | Probable | Definite | |
|---|---|---|---|---|---|
Relationship to Device Malfunction | |||||
Relationship to Study Procedure | |||||
Relationship to Underlying Disease | |||||
Relationship to Concomitant Medication |
Alternative Explanations for Event (if any)
Were clinical signs or symptoms observed?
Were vital signs affected?
Were laboratory values affected?
Were imaging studies performed?
Was medical intervention required?
Did this event require hospitalization or prolong existing hospitalization?
Current Outcome Status
Resolved with no sequelae
Resolved with sequelae
Ongoing/Not resolved
Fatal
Unknown
Expected Resolution Date (if ongoing)
Follow-up Plan and Monitoring Schedule
Does this event impact trial integrity or blinding?
Document all actions taken to secure the device, maintain evidence integrity, and establish clear chain-of-custody for investigation. This is critical for root cause analysis and potential regulatory inspection.
Was the device immediately deactivated or powered off upon discovery?
Was the device removed from the patient or clinical environment?
Current Physical Status of Device
Intact and unaltered
Physically damaged
Contaminated with biohazard
Partially disassembled
Packaged for return
Unknown
Detailed Description of Device Condition
Current Quarantine Storage Location
Date and Time Quarantine Initiated
Chain of Custody Log (All Individuals Who Handled Device)
Full Name | Role/Title | Date/Time Handled | Action Taken | Signature Initials | |
|---|---|---|---|---|---|
Dr. Smith | PI | 6/30/2025, 9:20 AM | Removed from patient | DS | |
J. Doe | Study Coordinator | 6/30/2025, 9:45 AM | Packaged and labeled | JD | |
Is the device physically intact with no signs of tampering?
Does the device pose a biohazard or contamination risk?
Environmental Storage Conditions Monitoring
Parameter | Value | Unit | Recorded Date/Time | Within Acceptable Range? | |
|---|---|---|---|---|---|
Temperature | -20 | °C | 6/30/2025, 10:00 AM | ||
Humidity | 45 | % RH | 6/30/2025, 10:00 AM | ||
Has the device been modified, repaired, or had any components replaced since the incident?
Supporting Evidence and Documentation Captured (select all that apply)
Device error logs downloaded
Photographs of device
Video of malfunction
Patient medical records
Witness statements
Environmental monitoring data
None captured
Upload Photographs of Device Condition and Quarantine Setup
Upload Device Error Logs, Data Files, or Digital Evidence
Is the device planned to be returned to the manufacturer for investigation?
Special Handling or Storage Instructions
This section determines regulatory reporting obligations under applicable medical device regulations. Accurate assessment ensures timely submission within mandatory timelines and audit readiness.
Is this incident reportable to regulatory agencies under medical device reporting regulations?
Date Incident Occurred (Awareness Start Date for Reporting Clock)
Date of Awareness (When Site First Knew or Should Have Known)
Calculated 15-Day Reporting Deadline
Report Type
Initial Report
Follow-up Report
Final Report
Seriousness Criteria Met (select all that apply)
Death of patient
Serious injury
Life-threatening event
Hospitalization required
Persistent significant disability/incapacity
Medically important event
No serious criteria met (malfunction only)
Device Malfunction Classification
Class I - No risk of adverse health outcome
Class II - Remote risk of adverse health outcome
Class III - Moderate risk of adverse health outcome
Class IV - High risk of adverse health outcome
Not a malfunction
Have similar events been reported previously for this device or protocol?
Regulatory Reference Number (if this is a follow-up report)
Has the sponsor organization been formally notified of this incident?
Regulatory Affairs Contact Person Name
Regulatory Affairs Contact Email
Regulatory Affairs Contact Phone
Upload Sponsor Notification Email or Correspondence
I confirm that all information provided is accurate and complete to the best of my knowledge for regulatory audit purposes
Final authorization by clinical and safety leadership confirming risk assessment, quarantine approval, and regulatory compliance. Both signatures are mandatory for form submission.
Principal Investigator Full Name
Principal Investigator Credentials (MD, PhD, etc.)
Principal Investigator Email
Principal Investigator Phone
Medical Safety Officer Full Name
Medical Safety Officer Credentials
Medical Safety Officer Email
Medical Safety Officer Phone
Overall Risk Assessment Classification
Critical - Immediate threat to patient safety, requires urgent action
High - Significant risk, requires prompt intervention
Medium - Moderate risk, requires monitoring and mitigation
Low - Minimal risk, routine handling
Joint Clearance Decision
Approve immediate quarantine and suspend device use
Approve quarantine with conditional release for investigation
Reject quarantine - device may continue in trial with monitoring
Require additional information before decision
Escalate to Independent Safety Committee
Conditions or Restrictions for Clearance (if applicable)
Has the Independent Ethics Committee or IRB been notified?
Is Data Safety Monitoring Board (DSMB) review required?
Principal Investigator Digital Signature
Medical Safety Officer Digital Signature
Final Sign-Off Date and Time
Both signatories confirm they have reviewed all sections, attachments, and attest to the accuracy and completeness of this report