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SOP No.: SOP-CO-03

Revision: Original
Effective Date:

Your Research Site

Your Research Address
Your Research City
Standard Operating Procedure

Confidential & Proprietary Information

Department: Area(s)

Title: SOP No.: SOP-CO-03

Effective Date: Revision:

Approving Official: Clinical Investigator

_______________________________ ______________________________
Name (Printed) Title

_______________________________ ______________________________
Signature Date of Approval
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SOP No.: SOP-CO-03
Revision: Original
Effective Date:

CORRECTIVE AND PREVENTATIVE ACTIONS

1. PURPOSE

2. SCOPE

3. BACKGROUND

This procedure is conducted in accordance with:

4. PROCEDURE
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SOP No.: SOP-CO-03
Revision: Original
Effective Date:

5. Revision Tracking or
Reapproval
Documentation
Position Signature Date Signed Description of
Revision(s); Date of
Revision(s); Note if
Signature(s) is for
Reapproval Only
Medical Director

Director of Clinical Research

Assessment Tracking Log

Sponsor Protocol List and Describe Clinical Research Date(s) of

Number Document, System, or Team Member Review
Facility Inspection Performing
Performed Review
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SOP No.: SOP-CO-03
Revision: Original
Effective Date:

Assessment Plan

Protocol Number: ______________ Assessment Plan Issued Date: __________

Sponsor: _____________________ Issuer’s Initials: ____________
Date(s) of Review: ________________
Reviewer(s): _______________________________

Overall Purpose of the Assessment:

Describe the System, Documents, and/or Facility to Be Assessed:

List Clinic Research Team Members to be Involved:

Lead Reviewer:

Additional Comments:

Expected Initial Preliminary Timeline:

Initial Update:
Expected Completion:

_________________________ _________________
Clinic Director Signature Date of Signature
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SOP No.: SOP-CO-03
Revision: Original
Effective Date:
_________________________ _________________
Clinical Investigator Signature Date of Signature
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SOP No.: SOP-CO-03
Revision: Original
Effective Date:

CORRECTIVE and PREVENTATIVE ACTIONS

FORM
Section I

Identified Issue:

Section II

Casual Analysis:

Section III

Proposed Resolution(s):

Section IV

Final Root Causal Analysis

Issued Resolved On: ____________________

Continuing to be Reviewed: ______________ Next Planned Assessment: ___________________
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SOP No.: SOP-CO-03
Revision: Original
Effective Date:
Issue Completion Tracking Log

Assessment Date: Reviewer(s): _______________

Investigator: __________________ Prepared By: ___________ Date: __ __________

Protocol Number(s): ________________

Corrective Action Review:

Clinical Research Director: __________________ Date: ________

Clinical Investigator: _______________________ Date: ________

Completion Responsible Completion

Observation(s) Recommendation Corrective Action Target Date Person(s) Date