Scribd Logo
Upload

Welcome to Scribd!

  • 190 views

    Prep 29 Capa Template

    Uploaded by

    Nilesh Sargara
    A CAPA is written to address problems identified in clinical research studies. It should identify the root cause of the problem, describe corrective actions taken to prevent recurrence, and ensure the corrective action resolved the issue. The CAPA should be authored by the responsible individual or organization, include a root cause analysis, corrective actions, and preventative actions. It follows a specific template, is signed by the author, and provided to the IRB and study monitors.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd

    Prep 29 Capa Template

    Uploaded by

    Nilesh Sargara
    190 views2 pages
    A CAPA is written to address problems identified in clinical research studies. It should identify the root cause of the problem, describe corrective actions taken to prevent recurrence, and ensure the corrective action resolved the issue. The CAPA should be authored by the responsible individual or organization, include a root cause analysis, corrective actions, and preventative actions. It follows a specific template, is signed by the author, and provided to the IRB and study monitors.

    Original Description:

    CAPA

    Copyright

    © © All Rights Reserved

    Available Formats

    PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    A CAPA is written to address problems identified in clinical research studies. It should identify the root cause of the problem, describe corrective actions taken to prevent recurrence, and ensure the corrective action resolved the issue. The CAPA should be authored by the responsible individual or organization, include a root cause analysis, corrective actions, and preventative actions. It follows a specific template, is signed by the author, and provided to the IRB and study monitors.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    190 views2 pages

    Prep 29 Capa Template

    Uploaded by

    Nilesh Sargara
    A CAPA is written to address problems identified in clinical research studies. It should identify the root cause of the problem, describe corrective actions taken to prevent recurrence, and ensure the corrective action resolved the issue. The CAPA should be authored by the responsible individual or organization, include a root cause analysis, corrective actions, and preventative actions. It follows a specific template, is signed by the author, and provided to the IRB and study monitors.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    You are on page 1of 2

    GUIDELINES FOR WRITING A CAPA

    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

    Version 03/29/2013 CAPA Template ORC


    GUIDELINES FOR WRITING A CAPA

    CAPA Template

    The following is a template for the content and format of a CAPA to the study
    investigators.

    [Institution Letterhead]

    Date: [Date that the CAPA is written]


    To: [ IRB]
    From: [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.]

    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

    Version 03/29/2013 CAPA Template ORC

    You might also like

    pFad - Phonifier reborn

    Pfad - The Proxy pFad of © 2024 Garber Painting. All rights reserved.

    Note: This service is not intended for secure transactions such as banking, social media, email, or purchasing. Use at your own risk. We assume no liability whatsoever for broken pages.


    Alternative Proxies:

    Alternative Proxy

    pFad Proxy

    pFad v3 Proxy

    pFad v4 Proxy