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    Template Creating Sops

    Uploaded by

    windi roxymusic

    Copyright:

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

    Template Creating Sops

    Uploaded by

    windi roxymusic
    176 views3 pages

    Copyright

    © © All Rights Reserved

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    DOC, PDF, TXT or read online from Scribd

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    Copyright:

    © All Rights Reserved
    Download as DOC, PDF, TXT or read online from Scribd
    Download as doc, pdf, or txt
    176 views3 pages

    Template Creating Sops

    Uploaded by

    windi roxymusic

    Copyright:

    © All Rights Reserved
    Download as DOC, PDF, TXT or read online from Scribd
    Download as doc, pdf, or txt
    You are on page 1of 3

    STANDARD OPERATING PROCEDURE Insert Department

    SOP No: Insert number


    SOP Title: Insert title

    SOP Number Insert Number


    SOP Title Insert Title

    NAME TITLE SIGNATURE DATE


    Author

    Reviewer

    Authoriser

    Effective Date:
    Review Date:

    READ BY

    NAME TITLE SIGNATURE DATE

    Adapted from CTRG Template SOP Version 2.1


    © Copyright: The University of Oxford 2009
    Page 1 of 3
    STANDARD OPERATING PROCEDURE Insert Department
    SOP No: Insert number
    SOP Title: Insert title

    1. PURPOSE
    A brief description of the purpose of the SOP, it should describe why the SOP is
    required (e.g. compliance with GCP and other internal procedures and guidelines).
    Any regulations or procedures referred to in “Purpose” section should be identified.
    The source should be given in the reference section rather than direct quotes.

    2. INTRODUCTION
    A general introduction, with a statement of rationale.

    3. SCOPE
    A statement that outlines the areas and context covered by the SOP.
    If there are any areas in which this SOP specifically does NOT apply, these should
    also be mentioned.

    4. DEFINITIONS
    When appropriate, a list of definitions should be included for terms used in the SOP.
    Acronyms and abbreviations should be explained at the point of use within the SOP
    and not listed in this section.

    5. RESPONSIBILITIES
    A summary of the roles listed in the procedure and the responsibilities of each role
    holder for the procedures detailed in the SOP.
    The details of the responsibilities should be a brief list of the key tasks performed.
    This section should not be a complete summary of the SOP.

    6. SPECIFIC PROCEDURE
    This section is the main text of the SOP. It details the procedure for the task to be
    performed.
    There should be sufficient detail, clearly expressed, to enable a trained person to
    perform the procedure without supervision.
    There should also be sufficient detail to enable a trained person to use the document
    to train others to perform the task.
    The use of flow diagrams may be useful, especially in complex procedures.

    7. FORMS/TEMPLATES TO BE USED
    Where Forms/Templates are referenced in the text, the numbers and titles are listed
    under this section.

    Adapted from CTRG Template SOP Version 2.1


    © Copyright: The University of Oxford 2009
    Page 2 of 3
    STANDARD OPERATING PROCEDURE Insert Department
    SOP No: Insert number
    SOP Title: Insert title

    8. INTERNAL AND EXTERNAL REFERENCES


    This section is used to list all controlled internal references (e.g. SOPs) and external
    references referred to within the text of the SOP only.

    8.1 Internal References


    Insert relevant references as required, sufficient for the user to find the source
    document.

    8.2 External References


    Insert relevant references as required, sufficient for the user to find the source
    document. Web references should be included were possible.

    9. CHANGE HISTORY
    Where the SOP is the initial version:
     SOP No: Record the SOP and version number
     Effective Date: Record effective date of the SOP or “see page 1”
     Significant Changes: State, “Initial version” or “new SOP”
     Previous SOP no.: State “NA”.
    Where replacing a previous SOP:
     SOP No: Record the SOP and new version number
     Effective Date: Record effective date of the SOP or “see page 1”
     Significant Changes: Record the main changes from previous SOP
     Previous SOP no.: Record SOP and previous version number

    Effective Previous
    SOP no. Significant Changes
    Date SOP no.

    Adapted from CTRG Template SOP Version 2.1


    © Copyright: The University of Oxford 2009
    Page 3 of 3

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