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?
Monitor Name and Organization
Method of Identification
Was this deviation discovered during an internal or external audit?
Audit Type and Auditor Details
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
Informed Consent Specific Issue
Consent not obtained before procedure
Incorrect version used
Missing signatures/initials
Consent process not documented
Legally authorized representative issues
Translation issues
Re-consent not obtained after amendment
Other
Eligibility Specific Issue
Inclusion criteria not met
Exclusion criteria not met
Medical history not properly reviewed
Laboratory value out of range
Prior therapy washout period insufficient
Age criteria not met
Other
Drug Administration Specific Issue
Incorrect dose
Incorrect route
Incorrect timing
Incorrect preparation
Storage temperature deviation
Blinding compromised
Accountability issue
Patient compliance
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?
Describe previous similar deviations for this subject
Is this a new type of deviation for this site?
Describe any trends or patterns observed
Deviation Severity Classification
Minor
Moderate
Major
Critical
Does this deviation constitute a protocol violation (more serious than a deviation)?
Explain why this is classified as a violation rather than a deviation
Was a protocol amendment required to address this issue?
Amendment Number
Supporting Documentation Required (check all that apply)
Source document worksheets
Medical records
Photographs
Laboratory reports
Pharmacy records
Training records
Communication logs
None required
Upload source documents
Upload medical records
Upload photographs
Upload laboratory reports
Upload pharmacy records
Upload training records
Upload communication logs
Related Deviations (if this is part of a pattern)
Related Deviation ID | Date of Related Deviation | Category | Brief Description | Resolution Status | ||
|---|---|---|---|---|---|---|
A | B | C | D | E | ||
1 | ||||||
2 | ||||||
3 | ||||||
4 | ||||||
5 | ||||||
6 | ||||||
7 | ||||||
8 | ||||||
9 | ||||||
10 |
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?
Explain what information was provided to the subject
Was the subject's legally authorized representative notified?
Explain notification details
Was protocol-specific re-training conducted for study staff?
Describe training content and attendees
Was the study drug/Investigational Product adjusted or modified?
Describe modifications made
Were additional safety assessments ordered?
List additional assessments
Was the subject withdrawn from the study?
Provide withdrawal rationale
Will these corrective actions prevent recurrence?
Corrective Action Tracking
Action Item | Responsible Person | Target Completion Date | Actual Completion Date | Completed? | Verification Method | ||
|---|---|---|---|---|---|---|---|
A | B | C | D | E | F | ||
1 | |||||||
2 | |||||||
3 | |||||||
4 | |||||||
5 | |||||||
6 | |||||||
7 | |||||||
8 | |||||||
9 | |||||||
10 |
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?
Explain specific impact on primary endpoint
Does this deviation affect any secondary endpoints?
List affected secondary endpoints
Does this deviation affect safety data reporting?
Explain safety data implications
Does this deviation affect pharmacokinetic/pharmacodynamic data?
Explain PK/PD data implications
Will data from this subject be excluded from analysis?
Provide statistical analysis plan modifications
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?
Describe prevention measures that should have been in place
Was an Adverse Event (AE) or Serious Adverse Event (SAE) reported in relation to this deviation?
AE/SAE Report Number
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?
PI Revised Severity Classification
Minor
Moderate
Major
Critical
Principal Investigator Digital Signature
PI Signature Date
Is IRB notification required for this deviation?
IRB Reporting Rationale
Has IRB notification been submitted?
IRB Notification Submission Date
Has IRB response been received?
IRB Response Summary
Is regulatory authority notification required?
Regulatory Authorities to Notify
FDA
EMA
Competent Authority
Health Canada
TGA
Other
Has regulatory authority notification been submitted?
Regulatory Notification Date
Has sponsor been notified?
Sponsor Notification Date and Time
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 | ||
|---|---|---|---|---|---|---|---|
A | B | C | D | E | F | ||
1 | |||||||
2 | |||||||
3 | |||||||
4 | |||||||
5 | |||||||
6 | |||||||
7 | |||||||
8 | |||||||
9 | |||||||
10 |
To configure an element, select it on the form.