Academic Medical Centers (AMCs) and health systems often rely on Microsoft SharePoint as a document management solution for clinical trials. With its widespread adoption across institutions and integration with existing IT infrastructures, SharePoint may seem like a practical and cost-effective alternative to a purpose-built electronic regulatory (eReg/eISF) system. However, clinical trials operate under rigorous compliance and operational requirements that SharePoint was never designed to meet.
Despite its flexibility, SharePoint lacks critical functionality for regulatory compliance, audit readiness, document version control, and workflow automation. These gaps introduce significant risks, including compliance violations, inefficiencies in document management, and challenges in maintaining inspection readiness. While some AMCs attempt to bridge these deficiencies with manual processes or third-party plug-ins, these workarounds often increase complexity and the likelihood of errors. This article explores the pitfalls of using SharePoint as an eReg/eISF substitute and why purpose-built eReg/eISF systems are the superior choice for AMCs.
Regulatory Compliance Shortcomings
Clinical trials operate under strict regulatory frameworks such as FDA 21 CFR Part 11, ICH-GCP, EMA, and institutional review board (IRB) requirements. To remain compliant, research institutions must ensure robust auditability, enforceable electronic signatures, and structured version control – areas where SharePoint falls short.
Lack of 21 CFR Part 11 Compliance
One of the most critical shortcomings of SharePoint is its inability to meet 21 CFR Part 11 compliance. Regulatory authorities mandate that electronic systems provide robust user authentication, maintain an immutable audit trail, and enforce electronic signature validation with clear attribution. SharePoint’s native capabilities lack these essential compliance controls, allowing users to modify or delete records without proper tracking. Institutions relying on manual audit logs or third-party add-ons often find these solutions incomplete, difficult to manage, and non-compliant with FDA standards.
Gaps in Audit Trails and Compliance Oversight
An effective eReg/eISF system enables real-time document tracking, automated approval workflows, and seamless audit readiness. SharePoint, on the other hand, lacks a centralized compliance dashboard, making it difficult to track document approvals, monitor changes, and generate real-time reports. Without structured oversight, research teams often find themselves scrambling to locate critical files, confirm signatures, and verify version histories. These gaps introduce significant compliance vulnerabilities that can delay trial milestones and introduce risk of regulatory findings.
Version Control & Document Integrity Risks
Regulatory documentation undergoes frequent updates throughout the lifecycle of a clinical trial, making precise version control an essential component of compliance. SharePoint’s approach to version history is not designed for the stringent requirements of clinical research. This can lead to serious operational challenges.
Conflicting Edits & Lost Data
Many AMCs encounter issues where multiple users edit the same document simultaneously, causing conflicting versions or inadvertent data loss. Without a structured system to manage changes, research teams often struggle with version confusion, referencing outdated documents, or failing to track critical amendments. These inconsistencies can lead to regulatory compliance risks and inefficiencies in trial execution.
“File Not Found” & Folder Disruptions
Another common pitfall is SharePoint’s lack of structured file management. Users can rename or move files freely, often resulting in broken links, misplaced regulatory documents, and “File Not Found” errors. Unlike a dedicated eReg/eISF system, which maintains strict version integrity and prevents unauthorized modifications, SharePoint requires manual oversight. Ultimately, this is an unsustainable practice for high-volume clinical trials.
Accidental Overwriting of Regulatory Documents
SharePoint also presents risks related to accidental overwriting of regulatory content. Without a lock-and-release mechanism, users can mistakenly replace existing files, potentially erasing critical compliance information. A purpose-built eReg/eISF prevents this by enforcing document versioning, automated approval workflows, and controlled access permissions. These powerful features safeguard that no document is lost or improperly modified.
Security & Access Control Limitations
Clinical trial documentation contains sensitive patient data, regulatory submissions, and investigator credentials, requiring strict access control. SharePoint’s permissions model is prone to misconfigurations, often leading to unauthorized access, accidental data loss, or exposure of confidential information.
The Risks of Complex Permissions Management
The sensitive nature of clinical trial documentation necessitates strict access control and data security. Unlike a dedicated eReg/eISF solution, which offers pre-set regulatory roles and strict user-based permissions, SharePoint requires manual permission assignments, which increases the risk of human error and security breaches. In fact, many teams frequently encounter issues where users are granted inappropriate access or inadvertently locked out of critical files.
Accidental Data Loss & Compliance Violations
Yet another security concern with SharePoint is the potential for accidental data deletion. SharePoint allows users with appropriate permissions to modify, move, or delete files—but without a built-in recovery safeguard. Regulatory documents must be protected from unintended alterations, and without a structured, tamper-proof control system, organizations risk losing critical compliance records, jeopardizing trial integrity and inspection readiness.
Collaboration Challenges
Many AMCs and site networks conduct clinical trials across multiple therapeutic divisions or locations, requiring seamless document sharing, standardized version control, and compliance oversight. SharePoint does not provide a centralized compliance framework, making it difficult to ensure consistency across research sites.
However, a dedicated eReg/eISF solution creates a centralized, single source of truth, ensuring that all participating teams and sites access the most up-to-date regulatory documents while maintaining strict access controls, version integrity, and real-time compliance monitoring across various locations.
The Case for a Purpose-Built eReg/eISF System
While SharePoint is a widely used enterprise solution, it was never designed to meet the unique needs of clinical research compliance. Its limitations in audit readiness, version control, document security, and workflow automation make it a poor substitute for a dedicated eReg/eISF solution. AMCs that attempt to adapt SharePoint for regulatory use often find themselves burdened by compliance risks, operational inefficiencies, and increased administrative workload.
Investing in a purpose-built eReg/eISF solution enables institutions to achieve full regulatory compliance, streamline document workflows, and improve overall efficiency in clinical trial operations. With automated version control, structured workflows, real-time document tracking, and better security measures, an eReg/eISF platform provides the reliability and oversight required to manage clinical research documentation with confidence.
Rather than relying on SharePoint as a workaround, AMCs should adopt an eClinical solution designed to support the complex regulatory requirements and operational demands of clinical trials. By making this strategic shift, institutions can ensure compliance, inspection readiness, and seamless collaboration, ultimately driving more efficient and successful research outcomes.
About RealTime-eReg/eISF
From the pioneers of eDocs and Complion eISF, our user-friendly electronic document management and regulatory systems are built for clinical research sites and academic medical centers. Eliminate paper clutter and simplify document storage, retrieval, and collaboration across site teams or departments. Explore RealTime-eReg/eISF here.
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