All clinical trials collect regulatory documentation in order to receive authorization to conduct the trial at investigative sites. Trials require a Regulatory Binder and many keep separate Study Binders.
All clinical trials collect regulatory documentation in order to receive authorization to conduct the trial at investigative sites. Trials require a Regulatory Binder and many keep separate Study Binders. Some sponsors provide the binders to the investigative sites while others mandate that the investigative site personnel compile and maintain them.
Both the sponsor and investigative site personnel have a vested interest in keeping it accurate and current. It should be available for Clinical Research Associate site visits, sponsor personnel, subcontractors of the sponsor, institutional auditors and/or any regulatory authorities visiting the site for the purpose of an audit.
Trial Interactive offers a complete solution for electronic distribution of essential documents and other sponsor and/or CRO forms that need to be completed. These forms can be auto-populated with site-specific information prior to their distribution to study site personnel. All information, including the electronic signature, can be completed virtually, resulting in a paperless process. Trial Interactive includes workflow to promptly facilitate the review and approval by the trial sponsor and then provides an organized, searchable electronic Regulatory Binder and Study Binders if required by the sponsor or institution. This offers advantages for all trial stakeholders including:
• Prompt submission of documents needing review and approval to sponsor
• Shorter cycle time for approval of all documentation reducing the time to study start up
• Indexed electronic binders that mimic what is kept in paper format
• Clinical trial template forms available for use or configuration per trial; sponsor, CRO or investigative site forms can be used alternatively
• Real time availability of information to CRAs and institutional personnel needing access to review information
• Search capability, which allows investigative site personnel to quickly find documentation rather than flipping through binders tabs and reams of paper
• Archival at the end of the trial, which offers an easy searchable index in case an audit is required without potential loss of paper or binders throughout the trial or upon close-out due to poor archiving processes