eISF

Clinical Operations: the eTMF Business Lead at the sponsor will understand the requirements of the protocol and know if an eISF is required for site document capture. Additionally, they will be able to advise on the approach necessary to handle site and PHI/PII data within the eISF and eTMF to determine if document redaction is required.

An eISF is ideal for four primary user types: eISF Administrators, Site Users, Study Managers, and CRAs. Each of these primary user types have roles and responsibilities unique to the eISF solution.

The Trial Interactive eISF gives complete access to appointed administrators seeking to control the security and room settings, manage user access, and manage sites during the course of a study. Administrators of rooms are not only able to create users, assign users to specific security or activity groups, manage user access to folders and documents but also revoke access to any user within the room. Administrators can create new sites, manage existing sites, update site security, convert site contacts to users as well as update room settings and delegate certain activities to other users in the room as needed.

Site users such as site coordinators, principal and sub investigators, and any other site users who need limited access to their own documents is the second primary user type. Site users are granted access by an administrator to specific sites within the system. Most site users have the ability to access uploaded site documents, upload new documents and update metadata information. Site users also have the ability to create and sign documents within the collaborative review process and have the potential to create documents from existing document templates that have been uploaded to a room. Certain site users will have access to a restricted document folder as well as the ability to redact uploaded documents as needed.

The third type of primary user is the CRAs and monitors involved in the oversight of sites on behalf of the sponsor. CRAs and monitors are granted access by an administrator as a site user with access to their assigned sites but also to additional functions to be used in conjunction with the TMF solution. CRAs and monitors are expected to be given access to multiple sites and their restricted site folders to be able to perform source and site document verification and leverage this access to perform remote site monitoring visits.

Study managers or other sponsor staff involved in the course of a clinical trial are the fourth type of primary users of an eISF. A study manager or other sponsor user would be restricted to certain site folders, if they have access at all to site folders. Sponsor users typically have access to create new sites within the eISF room as sites are activated during the course of a study. Sponsor users also have the ability to upload new documents to share with site users. These users also typically have the ability to create a document from a document template, open collaborative reviews with site users, and send documents for signature.

The eISF room provides the following business case goals:

• Simplified Storage and Accessibility for Regulatory Inspections: An eISF repository ensures that storage of site document or Restricted Content is managed seamlessly, without the usual stress associated with the management of these sensitive documents and data. It guarantees that all necessary documents are accessible for inspectors and can be filed contemporaneously. Regulatory bodies often require immediate access to trial documents during inspections. Traditional methods of storage can lead to difficulties in locating documents quickly, especially under time constraints. By using an eISF, organizations can ensure that all documents are stored in a centralized, easily accessible location. This not only reduces the stress and time associated with preparing for inspections but also ensures compliance with regulatory requirements by maintaining up-to-date and well-organized records.
• Ensuring Compliance with Regulatory Standards and Guidelines: Using an eISF repository helps organizations stay compliant with regulatory standards and guidelines, as well as internal Standard Operating Procedures (SOPs). This includes ensuring that Monitoring Visit Reports and Letters are provided to the site in a timely manner, correlating with the effective date of the document. Compliance with regulatory standards is critical in the pharmaceutical and clinical research industries. Failure to adhere to these standards can result in significant penalties, delayed approvals, and damaged reputation. An eISF repository facilitates adherence to these standards by providing tracking mechanisms that ensure timely submission and proper documentation of site activities. This systematic approach minimizes the risk of non-compliance and enhances the integrity and credibility of the site and trial data.
• Protecting Study Integrity: Maintaining the eISF in clinical trials is essential to ensure the protection of sensitive participant information and the validity of the study. Unintentional unblinding of participant information or results can compromise the integrity of the trial, leading to inconclusive or invalid results. This not only wastes the significant financial and human resources invested in the study but can also result in reputational damage to the organization as well as the site. By using an eISF repository, organizations can securely manage and control access to sensitive information, reducing the risk of information leaks. This secure management is crucial for preserving the scientific integrity of the trial and maintaining trust with site staff, study participants, stakeholders and regulatory authorities.