Healthcare Protocol Deviation Log

HEALTHCARE PROTOCOL DEVIATION LOG

Purpose: Use this log to record any deviation from an approved clinical protocol, standard operating procedure, or study plan that may affect subject safety, rights, welfare, or data integrity. The person completing this form certifies that the information is accurate to the best of their knowledge and understands that submission will initiate formal review and corrective action as required by institutional policy and applicable regulations. All attachments and source documentation referenced herein must be retained in the study file.

Facility & Protocol Information

Subject / Patient Information (if applicable)

Date of Birth:    Gender:

Insurance & Medical History (relevant to deviation)

Deviation Details

Date of deviation:    Time of deviation:

Deviation Type (check all that apply):
Procedure    Consent    Data Collection    Medication/Treatment    Visit Window    Eligibility    Other:

Impact Assessment

Severity classification:
Minor (no impact to subject safety or data integrity)   Major (may impact data or require reporting)   Critical (actual or potential harm to subject)

Does this deviation affect subject safety? Yes    No

Does this deviation affect data integrity or study conduct? Yes    No

Root Cause Analysis

Contributing factors (check all that apply):
Training / Competency    Ambiguous or missing procedure    Equipment / Supply failure    Documentation error    Human error    Other:

Corrective and Preventive Actions (CAPA)

Notifications & Attachments

Was the Institutional Review Board / Ethics Committee notified? Yes    No

Date of IRB notification:    Method of notification:

Was the Sponsor notified? Yes    No

Date of Sponsor notification:

Regulatory reporting required? Yes    No

Source documents    Consent form(s)    Monitoring report    Photographs / scans    Other:

Review & Disposition

Final determination:
Non-reportable    Reportable to regulator    Requires immediate corrective action

Certification

By signing below I certify that the information contained in this protocol deviation log is complete and accurate to the best of my knowledge. I understand that knowingly falsifying records or willfully omitting material facts may subject me to disciplinary action and regulatory reporting. I authorize the review of related medical and study records as necessary for investigation and corrective action.

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