Designing a Website to Support a Multisite, International Clinical Trial

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.