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    A study website effectively functions as an electronic manual of operations (eMOO) for multisite clinical trials, ensuring 24/7 access to essential study materials for all personnel.

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    Area of Science:

    • Clinical Trials
    • Health Informatics
    • Research Operations

    Background:

    • Multisite clinical trials require continuous access to up-to-date study materials for safe and reliable protocol implementation.
    • Study websites can serve as a central, accessible electronic manual of operations (eMOO) to support trial conduct.

    Purpose of the Study:

    • To describe the development, organization, and maintenance of a study website serving as an eMOO.
    • To facilitate efficient communication in a complex, multisite, international clinical trial.

    Main Methods:

    • Developed a study website in collaboration with an information technology department.
    • The website features a public homepage, a patient/family section, and three password-protected portals for study sites, investigators, and the operations team.

    Main Results:

    • The public homepage aids potential participants and sites. The patient/family section supports engagement.
    • Dedicated portals provide essential information for study sites, investigators, and operations teams, facilitating study management and patient care.
    • Recommendations for future development include IT collaboration, defined version control, and use of unmodifiable file formats.

    Conclusions:

    • Study websites are valuable tools for managing complex multisite clinical trials.
    • The developed eMOO model offers significant operational value and is applicable to other multisite research endeavors.