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Tool Summary Sheet

By Valerie Warren,2014-06-28 20:15
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Tool Summary Sheet

    Tool Summary Sheet

    Tool: Protocol Amendment Summary of Changes Template

    Purpose: To support the documentation of changes from one IRB approved version

    of a protocol to the next

    Audience/User: The protocol amendment author will use the tool to create the summary

    of changes.

    Best Practice ; Administrative details of template

    Recommendations: o Review this template and customize to the specific needs

    and requirements of the study. Sample text may be

    updated as needed.

    o In the template, the instructions and explanatory text are

    indicated by {blue italics}. Instructional text will also be

    enclosed in braces to signify this text for screen-readers

    used by the visually impaired.

    o Text enclosed with <> is a placeholder for a specific detail

    (e.g., <protocol title>); replace as appropriate.

    o Remove <> and instructional text before finalizing the

    document.

    ; Pre-amendment

    o It is useful to maintain an ongoing list of potential protocol

    changes: both administrative changes as well as

    substantive changes that are being considered for

    inclusion in a protocol amendment. Some maintain a

    working version of a protocol amendment where the

    POTENTIAL changes have been tracked in a version of the

    protocol that is maintained separately from the active

    version.

    o To reduce paperwork and confusion, when possible it is

    helpful to batch protocol changes together into one

    amendment.

    o The list of potential changes should be vetted through the

    protocol team, prior to inclusion in the draft protocol

    amendment that is submitted to the IRB.

    ; Preparing and reviewing the protocol amendment summary

    document

    o Consider IRB-specific guidelines/preferences when

    Template Version: 1.0-20110330 1

    preparing the protocol amendment summary document.

    o The structure of the protocol amendment summary

    document may depend on the contents of the

    amendment. In some cases, it may be most appropriate to

    list the changes 1 by 1 as they appear in the protocol. In

    other cases, an ordering by conceptual change [e.g., 1)

    DSMB requested changes; 2) administrative changes] may

    be best.

    o When possible, protocol section numbers should be

    referenced. It is also helpful to reference page numbers.

    o Include a rationale for each set of protocol changes.

    Document as “Administrative change” when appropriate.

    o The protocol amendment summary document should be

    carefully reviewed and confirmed against the actual

    protocol amendment immediately before submission.

    Remember that page numbers change as things are

    updated in the protocol. It is therefore important to do a

    quality control check of the section and page numbers.

    ; It is best to submit a pdf of the protocol if you are referencing

    page numbers. This is because page numbers for pdfs are

    constant across all computer software and systems, whereas the

    pagination in MS Word documents is system/printer dependent.

    ; The protocol amendment summary document will be submitted

    to the IRB and will be stored in the study files and accessed by the

    study team.

    ; It is preferable to maintain both a track-changes and a clean

    version of the protocol version that is submitted to the IRB.

    Tool Revision History:

    Version

    Number Date Summary of Revisions Made:

    1.0 30March2011 Approved version

    Template Version: 1.0-20110330 2

    Detailed Summary of Protocol Changes Protocol Number:

    Protocol Title:

     Version Number Version Date

    Current Approved Protocol <Version # of most <Date of most

    recently approved recently approved

    protocol> protocol>

    Amended Protocol <Version # of <Date of amended

    amended protocol protocol being

    being submitted to submitted to the

    the IRB> IRB>

    Section and page numbers are references to the {indicate track-changes version, if that is what you are using} amended protocol.

    1. <Section Number, Section Title, Page Number(s)> Old Text:

New Text: {Include new text, preferably with track-changes on to reveal the differences from the

    previous version of the document}

Rationale for Change:

    2. <Section Number, Section Title, Page Number(s)> Old Text:

New Text: {Include new text, preferably with track-changes on to reveal the differences from the

    previous version of the document}

    Version Date: <insert date of Detailed Summary of Protocol Changes> 3

Rationale for Change:

    {Replicate above structure as needed for additional changes, ensure that the numbering is continuous}

    {The item below is a suggested final item that covers all remaining administrative updates that have not otherwise been detailed above.}

    3. Administrative changes: Minor changes involving grammar, wordsmithing, punctuation,

    and other editorial changes have been made throughout the document. All are clearly

    identified in the track-changes version of the amendment.

    Version Date: <insert date of Detailed Summary of Protocol Changes> 4

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