Scribd Logo
Upload

Welcome to Scribd!

  • 38 views

    Essential Documents For Research Studies

    Uploaded by

    abdurehman khan
    The document outlines essential documents that should be maintained in a study master file for any research study conducted by the Department of Medicine, including approval certificates, the study protocol and amendments, informed consent forms, training logs, and documentation of participant enrollment. It emphasizes that proper organization and filing of study documents is important for demonstrating compliance and ensuring successful study management. A study master file should be created at study initiation to house all required documentation.

    Copyright:

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

    Essential Documents For Research Studies

    Uploaded by

    abdurehman khan
    38 views2 pages
    The document outlines essential documents that should be maintained in a study master file for any research study conducted by the Department of Medicine, including approval certificates, the study protocol and amendments, informed consent forms, training logs, and documentation of participant enrollment. It emphasizes that proper organization and filing of study documents is important for demonstrating compliance and ensuring successful study management. A study master file should be created at study initiation to house all required documentation.

    Original Title

    doc 1

    Copyright

    © © All Rights Reserved

    Available Formats

    PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    The document outlines essential documents that should be maintained in a study master file for any research study conducted by the Department of Medicine, including approval certificates, the study protocol and amendments, informed consent forms, training logs, and documentation of participant enrollment. It emphasizes that proper organization and filing of study documents is important for demonstrating compliance and ensuring successful study management. A study master file should be created at study initiation to house all required documentation.

    Copyright:

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

    Essential Documents For Research Studies

    Uploaded by

    abdurehman khan
    The document outlines essential documents that should be maintained in a study master file for any research study conducted by the Department of Medicine, including approval certificates, the study protocol and amendments, informed consent forms, training logs, and documentation of participant enrollment. It emphasizes that proper organization and filing of study documents is important for demonstrating compliance and ensuring successful study management. A study master file should be created at study initiation to house all required documentation.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 2

    Essential Documents for Research Studies

    Research Office, Department of Medicine


    Version 1.0; November 12, 2013

    The core of a good trial or research study is the quality of the documentation. Organization and proper filing of essential
    study documents not only demonstrates compliance with good clinical practice but also ensure successful management
    of the study by the investigator, the team and if necessary the sponsor or coordinating site. At the initiation of any study
    a study master file should be created to keep all documentation listed here in one location. Each study should have its
    own file and this file should be maintained as needed to ensure all required documentation is current and accurate.

    Essential documentation required for any study conducted in the Department of Medicine is as follows:

    Title of Document Purpose of Document Version


    Controlled
    Research Ethics Board (REB) Approval Documentation of approval listing the approved consent forms, Yes
    Certificates and updates questionnaires, and study materials
    Site Approval Forms and Renewals Documentation of approval from the institution. For Fraser this
    will be in the form of a LOA, for other sites this may be an email
    conformation
    Regulatory Authority Approvals Documentation of all regulatory approval i.e. NOL from Health
    if applicable Canada
    Study Protocol and any Amendments - All members of the study team should be aware of the current Yes
    signed by all members of the investigative approved protocol
    team
    Information provided to study participants Documentation of all information which is approved and Yes
    including consent forms – all versions and authorized for use during the study
    applicable translations
    Training Log Documentation of necessary training required
    i.e. TPCS-2 certificates, protocol training logs etc.
    Participant identification code Documentation required in the event that participants must be
    if applicable unblinded
    Participant enrolment log Documentation of chronological enrolment of participants by
    study number (study number/dates)
    Case Report Form (CFR) Documentation of approved data collection forms for reference Yes
    if applicable
    Signed agreements between involved Any signed agreements which may be between
    parties investigator/site/institution which pertain to the study
    if applicable
    Financial Documentation Documentation for sub-site agreements or studies involving
    if applicable payment per patient or an agreed upon payment for service.
    Audit certificates Documentation of any audits of inspections done for the
    if applicable purposes of validation
    Signed informed consent forms Documentation that informed consent was obtained for all Yes
    study participants
    Final reports required for REB

    Page 1 of 2
    Essential Documents for Research Studies
    Research Office, Department of Medicine
    Version 1.0; November 12, 2013

    Additional Suggested Documentation for Studies as per GCP Guidelines

    Title of Document Purpose of Document Notes


    Organization Chart/ Delegation of Document who is authorized to work on May include a signature sheet which
    Authority Document the study, and the roles of each study provides a record of the signature and
    team member. Serves as historical record. initials of all individuals on the study.
    CV and Investigator Qualifications of Provide documentation of qualifications Each CV should be signed and dated
    Investigators / Sub-investigators May include copies of certificates for staff
    Normal Value(s)/range(s) for medical/ Provides a set reference for what is
    laboratory and test procedures which will considered to be normal values at the
    be performed as part of the study time of the study.
    Relevant Communications (including Documents discussions or information
    meeting notes, letters, memos) relevant to study administration, protocol
    violations, etc.

    Reference:
    ICH Guidelines Step 5, Canada
    Good Clinical Practice: Consolidated Guidance (ICH-E6)

    Page 2 of 2

    You might also like