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    Capa Sop

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    gubdia
    This document provides guidelines for writing a Corrective and Preventative Action (CAPA) plan to address problems identified during clinical research studies. A CAPA plan should identify the root cause of an issue, describe corrective actions taken to prevent recurrence, and document resolution of the problem. It includes conducting a root cause analysis, outlining corrective and preventative actions, evaluating implementation, and providing follow-up as needed. The CAPA plan is signed by the author and submitted to relevant oversight bodies like the IRB, sponsor, or data safety monitoring board.

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    Capa Sop

    Uploaded by

    gubdia
    1K views6 pages
    This document provides guidelines for writing a Corrective and Preventative Action (CAPA) plan to address problems identified during clinical research studies. A CAPA plan should identify the root cause of an issue, describe corrective actions taken to prevent recurrence, and document resolution of the problem. It includes conducting a root cause analysis, outlining corrective and preventative actions, evaluating implementation, and providing follow-up as needed. The CAPA plan is signed by the author and submitted to relevant oversight bodies like the IRB, sponsor, or data safety monitoring board.

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    Corrective and Preventive action Sop

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    This document provides guidelines for writing a Corrective and Preventative Action (CAPA) plan to address problems identified during clinical research studies. A CAPA plan should identify the root cause of an issue, describe corrective actions taken to prevent recurrence, and document resolution of the problem. It includes conducting a root cause analysis, outlining corrective and preventative actions, evaluating implementation, and providing follow-up as needed. The CAPA plan is signed by the author and submitted to relevant oversight bodies like the IRB, sponsor, or data safety monitoring board.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    1K views6 pages

    Capa Sop

    Uploaded by

    gubdia
    This document provides guidelines for writing a Corrective and Preventative Action (CAPA) plan to address problems identified during clinical research studies. A CAPA plan should identify the root cause of an issue, describe corrective actions taken to prevent recurrence, and document resolution of the problem. It includes conducting a root cause analysis, outlining corrective and preventative actions, evaluating implementation, and providing follow-up as needed. The CAPA plan is signed by the author and submitted to relevant oversight bodies like the IRB, sponsor, or data safety monitoring board.

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    of 6

    STANDARD OPERATING PROCEDURES (SOP) FOR CLINICAL Last Revised: 1/2017

    RESEARCH
    TITLE: Corrective and Preventive Action (CAPA) Plan Prior Version: None
    SOP Number: QA 503
    Page 1 of 3

    1. PURPOSE:
    The purpose of this SOP is to provide guidance to investigators and key study personnel in
    writing a CAPA plan to address and develop plans for existing or potential problems identified
    during the conduct of human subjects research.

    2. SCOPE:
    All human subjects research protocols conducted and approved by the UH Institutional Review
    Board (IRB), Centralized IRBs, or studies conducted at any UH facility or affiliate facility. This
    SOP will serve as a guide to research personnel with the steps to writing a CAPA plan.

    3. RESPONSIBLE INDIVIDUALS:
    All Investigators, research, regulatory and key study personnel who engage in human subjects
    research.

    4. DEFINITIONS:
    Corrective and Preventive Action (CAPA) Plan: actions taken to collect information and
    identify a problem, determine root cause, identify and implement a corrective and/or preventive
    action to prevent further recurrence.

    Root Cause: factor that caused a nonconformance and should be permanently eliminated through
    process improvement

    Root Cause Analysis: is a class of problem solving methods used to identify the root causes
    of problems or events.

    Corrective Action: Immediate action to a problem that has already occurred or has been
    identified.

    Preventative Action: Taken to eliminate the root cause of a potential problem including the
    detection/identification of problems.

    5. POLICY STATEMENT:
    A CAPA is written to identify a discrepancy or problem in the conduct of the clinical research
    study, note the root cause of the identified problem, identify the corrective action taken to prevent
    recurrence of the problem, and document that the corrective action has resolved the problem.

    6. PROCEDURES:

    Developed by the UH Clinical Research Center SOP Committee


    STANDARD OPERATING PROCEDURES (SOP) FOR CLINICAL Last Revised: 1/2017
    RESEARCH
    TITLE: Corrective and Preventive Action (CAPA) Plan Prior Version: None
    SOP Number: QA 503
    Page 2 of 3

    6.1 Form a team


    Identify t h e individual(s) responsible for:
    Developing the CAPA plan;
    Implementing the CAPA plan;
    Training staff on the CAPA plan;
    Evaluating of the results of the CAPA plan.

    6.2 Identify the issue or potential issue


    Document a brief description of the issue
    Evaluate the magnitude of the problem and potential impact
    Investigate the impact of the issue on the overall research

    6.3 Identify the root cause


    Describe the reason the issue arose
    Investigate how or why the incident occurred

    6.4 Describe the c orrective actions t a k e n o r p l a n n e d


    Indicate who will perform the corrective actions and when
    If items are incomplete or unavailable, include a statement regarding attempts made to
    complete the action
    Consider sponsor, regulator y (Food and Drug Administration, Office Human
    Research Protection, Office of Civil Rights) or local institutional requirements
    when creating the corrective action plan.

    6.5 Implementation
    Describe the procedures implemented to resolve the problem and indicate whos
    responsible for the procedure.

    6.6 Effective Date of Resolution


    Indicate an effective date for the corrective action

    6.7 Preventative Action


    Describe the preventative actions taken or planned and whos responsible
    Create a listing of all tasks that must be completed to correct or prevent the problem.

    Developed by the UH Clinical Research Center SOP Committee


    STANDARD OPERATING PROCEDURES (SOP) FOR CLINICAL Last Revised: 1/2017
    RESEARCH
    TITLE: Corrective and Preventive Action (CAPA) Plan Prior Version: None
    SOP Number: QA 503
    Page 3 of 3

    Send copy of the final CAPA to t h e appropriate authority if required in response


    to a deviation

    6.8 Evaluation and Follow-up


    Describe the procedure to evaluate the implementation and completion
    Indicate the study staff who are responsible for the evaluations
    Include the timeframe for evaluation
    Send evaluation follow-up report to appropriate authority if requested

    6.9 Comments-Optional
    Document observations

    7. REFERENCES
    Feinstein Institute for Medical Research
    http:// carllanderson. wordpress.com / 20 11/ 02/ 22capa-plans- for-clinic a l-trials-2/
    FDA 21 CFR 820.100
    Preventive/Corrective Actions (CAPA) Guidelines. R.M. Baldwin, Inc.

    8. FORMS OR ATTACHMENTS
    Appendix A - CAPA Template

    APPROVALS
    Approved by Dr. Grace McComsey, Associate Chief Scientific Officer, University Hospitals
    Health System, Director, UH Clinical Research Center June 1, 2017

    Developed by the UH Clinical Research Center SOP Committee


    How to Create a Corrective and Preventive Action Plan (CAPA)
    A CAPA is written to identify a discrepancy or problem in the conduct of the clinical research
    study, note the root cause of the identified problem, identify the corrective action taken to prevent
    recurrence of the problem, and document that the corrective action has resolved the problem. In
    general, the tone of CAPA should be forward- looking and not seek to explain an error discovered
    in the conduct of a clinical research study. For example, it may be appropriate to:

    Clarify or add information regarding site specific regulatory file requirements, Clarify or
    add information regarding source document standards,
    Document and address any issue that is protocol- and/or site-specific that cannot be
    resolved without a change from previous procedures.

    Key things need to be included in a CAPA:

    1) Root Cause Analysis: A class of problem solving methods used to identify the root
    causes of problems or events.
    2) Corrective Action: Immediate action to a problem that has already occurred or has been
    identified.
    3) Preventative Action: Taken to eliminate the root cause of a potential problem including
    the detection/identification of problems.

    A CAPA should be printed on institution letterhead and should be initiated and authored by the
    individual or organization responsible for its content, as follows:

    If the issue relates to actions taken by the sponsor or monitor (e.g., clarification of a protocol
    section), an appropriate credentialed individual from the sponsor should write and sign on the
    CAPA.

    CAPA should be signed by the author, submitted to the IRB for review, kept on file in the site
    regulatory file and made available to the clinical site monitors reviewing the sites documents
    and procedures.

    In addition, if a data safety monitoring board is handling the data management of the clinical
    research study, please forward a copy to the DSMB.

    Hints for working on your CAPA: PICCC: Problem, Investigate, Comparison, Clues, Cause

    Adapted from the Feinstein Institute for Medical Research


    GUIDELINES FOR WRITING A CAPA

    Corrective and Preventative Action Plan

    Date: [Date that the CAPA is written]


    To: [Sponsor, FDA, or IRB]
    From: [Name, title, and the site or institutional affiliation of the person authoring the
    CAPA, and this individuals signature]
    Protocol/IRB Number : [Name, title, and the site or institutional affiliation of the person authoring the
    CAPA, and this individuals signature]

    Issue: [Brief description or outline of the topic/process/problem being


    documented; can be formatted as a paragraph, numbered list, or
    bulleted items]

    Root Cause: [The reason(s) that the issue arose]

    Corrective Action: [Description of the corrective actions taken or planned by the site
    personnel. If the site was instructed to perform these corrective actions
    (i.e., by the sponsor or monitor), indicate by whom and as of what date. If
    status of reports, records, or data will remain incomplete or unavailable,
    make a statement regarding your failed attempts or describe when/how
    the records will be retrieved or completed.]

    Implementation: [Description of the procedures used to document resolution of the


    problem, the personnel who are responsible for the procedures etc.]

    Effective date of [Effective date for corrective action (may be the same date as in the
    resolution: memo header)]

    Preventive Action: [Description of the preventive actions taken or planned by the site
    personnel. If the site was instructed to perform these preventive
    actions, indicate by whom and as of what date.]

    Adapted from the Feinstein Institute for Medical Research


    Version 08.2016
    GUIDELINES FOR WRITING A CAPA
    Evaluation / [Any plan / procedure to evaluate the implementation and completion,
    Follow-up: personnel who are responsible for the evaluations, timeframe for the
    evaluation, etc.]

    Comments: [Any additional comments or information not noted above]

    Principal Investigator Signature Date of Signature

    Principal Investigator Printed Name

    Adapted from the Feinstein Institute for Medical Research


    Version 08.2016

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