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    PERIS WAMBUI
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    This document outlines the key stages and steps involved in planning and conducting a clinical trial. It begins with developing the research idea, conducting a literature review, establishing scientific merit and funding. It then describes finalizing the protocol and gaining necessary approvals. The next stage is conducting the trial, including managing recruitment, monitoring participants, addressing issues, and collecting data. Key responsibilities like oversight committees, documentation, and reporting are also mentioned. The overall summary provides a high-level overview of the clinical trial process from initial planning through active trial conduct.

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    This document outlines the key stages and steps involved in planning and conducting a clinical trial. It begins with developing the research idea, conducting a literature review, establishing scientific merit and funding. It then describes finalizing the protocol and gaining necessary approvals. The next stage is conducting the trial, including managing recruitment, monitoring participants, addressing issues, and collecting data. Key responsibilities like oversight committees, documentation, and reporting are also mentioned. The overall summary provides a high-level overview of the clinical trial process from initial planning through active trial conduct.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
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    13 views1 page

    FlowChart EG

    Uploaded by

    PERIS WAMBUI
    This document outlines the key stages and steps involved in planning and conducting a clinical trial. It begins with developing the research idea, conducting a literature review, establishing scientific merit and funding. It then describes finalizing the protocol and gaining necessary approvals. The next stage is conducting the trial, including managing recruitment, monitoring participants, addressing issues, and collecting data. Key responsibilities like oversight committees, documentation, and reporting are also mentioned. The overall summary provides a high-level overview of the clinical trial process from initial planning through active trial conduct.

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    © All Rights Reserved
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    of 1

    Stage

    Before the trial starts


    1 Develop Research
    Idea (CTP02)

    Systematic review of Gaining views of opinion leaders and Exploration of potential


    the literature (CTP02) establishing equipoise (CTP02) funding (CTP02)

    Research idea scientifically Potential funder


    and ethically sound (CTP02) found (CTP02)

    NO YES NO

    Approach collaborators (CTP02)

    1. Define clearly the interventions and outcomes (CTP02)


    2. Define design, methodology, statistical methods including sample size calculation (CTP02)

    Draft the proposal Risk


    and trial plan (CTP02) assessment
    Budget (CTP02) (CTP02)

    Funding secured and protocol finalised

    Trial oversight
    Responsibilities, Investigator’s Permissions Establish Organise
    Confirm committees Project Detail all Trial Unique Deal with Data
    roles and Recruitment Insurance Brochure and approvals administrative training and
    sponsor (DMC, TMG, Management trial documents Registration trial number logistics issues Management
    governance plan (CTP02) (CTP04) (if required) obtained (CTP04, procedures meetings
    (CTP03) TSC, EC) plan (TMF) (CTP04) (CTP02) (CTP02) (CTP02) (CTP02, CTP07)
    (CTP03) (CTP02) CTP05) (CTP02) (CTP02)
    (CTP03) (CTP02, CTP05)

    Trial Patient CRF Database Monitoring


    marketing participation design design (CTP09)
    (CTP08) (CTP08)
    Trial can start (CTP06) (CTP07)

    Stage During the trial


    2 Trial management and monitoring (CTP05)

    Informed GCP and Urgent GCP in


    Trial co-ordinating staff Inspection Protocol Pharmacovigilance/
    Investigator recruitment consent serious breach safety relation to
    recruitment and training and audit adherence Safety reporting
    and training (CTP08) (CTP03, reporting measures QA and QC
    (CTP05) (CTP09) (CTP09) (CTP07)
    CTP08) (CTP09) (CTP07) (CTP09)

    Recruitment
    Trial Contracts and Financial Addition of new Progress Substantial
    Trial supplies and Milestones
    documentation agreements management sites/investigators reporting amendments
    (CTP05) randomisation (CTP05)
    (CTP04) (CTP04) (CTP04, CTP05) (CTP08) (CTP11) (CTP09)
    (CTP08)

    Data management

    Management
    Data Data Data Central
    of data Training of CRF Data
    protection and cleaning and monitoring statistical Follow up
    documentation investigators completion entry
    confidentiality validation and SDV monitoring (CTP10)
    (CTP02, CTP07, (CTP07) (CTP07) (CTP07)
    (CTP07) (CTP07) (CTP07, CTP09) (CTP09)
    CTP11)

    Data entry Post entry


    checks checks

    Stage
    At the end of the trial
    3 End of trial
    management

    End of trial Statistical Site


    declaration Database
    data analysis close out
    lock (CTP11)
    (CTP05) (CTP11) (CTP05)

    Clinical Dissemination
    Archiving
    trial report of results
    (CTP05)
    (CTP11) (CTP11)

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