About the Author: Michele Corvino, Vice President of Product at RealTime eClinical Solutions, has more than 25 years of product management experience at companies such as Oracle, IBM Smarter Workforce, and Complion. As VP of Product, she designs and creates innovative solutions that improve clinical research efficiencies and helps customers focus on research and maximizing clinical outcomes. She holds a degree in Aeronautical and Astronautical Engineering from MIT.
Clinical researchers today face mounting regulatory pressures while trying to deliver faster trials, maintain quality, and do more with fewer resources. For compliance officers and regulatory professionals, the strain is especially acute. Buried in binders, paper trails, and repetitive workflows, it’s easy to feel like progress is slow. From chasing signatures to organizing binders and reconciling logs, regulatory and compliance teams are frequently caught in a cycle of inefficiency. The good news? The cycle can be broken. “Reducing Redundant Regulatory Work: The Compliance Officer’s Guide” explores how to eliminate redundant tasks in clinical trials, reduce human error, and streamline operations using a 21 CFR Part 11 compliant eRegulatory (eReg/eISF) solution.
The Burden of Redundancy in Clinical Trials
Clinical research site networks, academic medical centers, and health systems often juggle hundreds of documents per study across multiple systems. Manual processes like printing, signing, scanning, and filing are time-consuming. Moreover, they can also increase the risk of misplaced or outdated documents, missed approvals, and inconsistent audit trails. Common redundant tasks include:
- Requesting and tracking wet-ink signatures
- Filing multiple copies of the same document across studies
- Repeating site and staff credentialing processes
- Manually maintaining delegation logs and training records
- Chasing version control and document reconciliation across multiple trials
How eReg Became a Best Practice – The Digital Shift
The concept of eRegulatory (eReg) systems, also referred to as electronic Investigator Site File (eISF), began gaining traction in the early 2010s, as part of the broader digital transformation in clinical trials. Prior to that, most regulatory documentation was managed using paper-based binders. Sites relied on physical signatures, manual filing, and in-person monitoring visits. With growing pressure to improve inspection readiness, streamline audits, and reduce the burden of document management, eReg systems started appearing. Today, eReg is considered a best practice at high-performing research sites and site networks.
5 Ways eReg Eliminates Redundant Work
A modern eReg/eISF platform reimagines how regulatory workflows operate. Instead of chasing paper, duplicating documents, repetitive uploads, or managing approvals through email threads, eReg/eISF streamlines every step of the process. This electronic workflow delivers better outcomes for teams with reduced compliance risk and hours of valuable time savings. Altogether, the platform delivers faster startup, smoother inspections, and fewer manual headaches. Here’s how an eReg/eISF system eliminates redundant work:
1. Centralized Document Storage & Reuse
One of the most significant time drains for clinical research teams is the repetitive process of uploading, filing, and managing the same documents across multiple studies. From GCP training certificates and investigator CVs to medical licenses and lab certifications, regulatory teams often find themselves duplicating effort just to keep each study file complete. However, eReg/eISF solutions solve this through centralized document storage and intelligent reuse.
- Master Document Library: Instead of uploading the same document to each study folder, your team can store a single, authoritative version in a centralized library. Whether it’s a PI’s CV or a staff training certificate, you upload it once and assign it across any number of studies.
- Smart Linking Across Studies: The system links master documents to relevant studies, maintaining consistency and reducing room for human error. If an updated version is uploaded, like a renewed license, it instantly replaces the outdated version across all linked studies.
- Automated Updates & Version Synchronization: No more double work when credentials renew or documents are updated. The eReg/eISF system keeps every connected study current and audit-ready in real time.
- Streamlined Audit Preparation: During inspections, you can demonstrate compliance quickly and confidently. Auditors see clearly that the required documents are present, up to date, and traceable, without needing to shuffle through redundant copies.
By eliminating duplication and centralizing control, you dramatically reduce administrative burden, improve document quality, and accelerate study start-up timelines.
The Result: Less time chasing documents. More time moving trials forward.
2. Credential and Training Libraries
Keeping track of staff credentials and training records across multiple studies can quickly spiral into a time-consuming and error-prone process. Paper files, disconnected folders, and email reminders often lead to outdated documents, missed renewals, or inconsistent compliance across sites and departments. That’s where a centralized Credential and Training Library within an eReg/eISF platform makes a difference.
- One-Time Upload, Multi-Study Assignment: Upload a document once, such as a GCP certificate, medical license, CV, IATA, or HSP training, and assign it to multiple studies in seconds. No more duplicating files or manually updating each study folder.
- Automated Expiration Tracking: Built-in alerts and tracking fields notify you before a document expires. This helps avoid compliance gaps and ensures that expired credentials never derail a study or site audit.
- Easy Cross-Referencing and Reporting: Generate reports to see which team members have completed required trainings or whose credentials need renewal across all active studies. This makes onboarding faster, study startup smoother, and inspections less stressful.
With a Credential and Training Library, you’re creating a proactive, scalable system that helps maintain compliance without added manual work.
The Result: Staff are always study-ready, and your compliance documentation is always inspection-ready.
3. Digital Signatures and Workflow Automation
Modern eReg/eISF platforms replace outdated, manual processes like printing, signing, scanning, and emailing documents, all of which slow down study start-up and introduce opportunities for error or missed steps. With built-in digital signature capabilities that are fully compliant with 21 CFR Part 11, GDPR, and HIPAA, sites can now execute signatures electronically in a fraction of the time.
For example, instead of coordinating wet-ink signatures across multiple stakeholders for regulatory documents, a study coordinator can route a single document to PI, sub-I, and study staff with automated alerts and reminders. Once signed, the document is automatically time-stamped, audit-trailed, and stored in the correct study folder. No printing, chasing, or duplicate uploads required. Workflow automation doesn’t stop at signatures. With eReg, you can:
- Automatically route documents based on role, study, or department
- Trigger real-time alerts for pending approvals or expired credentials
- Auto-file signed documents in the appropriate location without manual filing
- Maintain complete version control with automatic reconciliation logs
The Result: Fewer handoffs, fewer delays, and fewer errors. Your team spends less time managing paperwork and more time moving trials forward.
4. Electronic Delegation of Authority (DOA) Logs
Delegation of Authority (DOA) logs are one of the most heavily scrutinized documents during audits and inspections, and also one of the most time-consuming to manage manually. Traditional methods often involve static spreadsheets or paper logs, which require frequent updates, manual cross-checks against training records, and can easily become outdated or incomplete.
With an eReg/eISF platform, electronic DOA logs are automatically populated and maintained, minimizing human error and drastically reducing administrative burden. Here’s how it works:
- Linked Staff Roles and Credentials: When a new staff member is added to the system or assigned to a study, their role, credentials, and training records are automatically pulled into the DOA log from the credentialing library.
- Electronic Signatures: Staff and PI signatures can be collected electronically and securely in full compliance with regulatory standards. All actions are audit-trailed with timestamps and signer identity.
This level of automation ensures that DOA logs are always current, complete, and inspection-ready. There’s no need to reconcile binders and spreadsheets or worry about a missing signature during a monitor visit.
The Result: Less time spent chasing updates. Fewer compliance risks. More confidence during audits.
5. Real-Time Version Control and Reconciliation
In clinical trials, working from the correct version of a regulatory document is a compliance requirement. Yet in paper-based or disconnected systems, version control is one of the most common sources of audit findings. Whether it’s outdated informed consent forms (ICFs), missing protocol amendments, or misfiled SOPs, manual reconciliation puts both time and trial quality at risk. eReg/eISF platforms solve this by automating version control and document reconciliation from the ground up.
- Automatic Version Tracking: Every upload, edit, or replacement creates a new version with a full audit trail, including who made the change, when, and why. This eliminates the guesswork and ensures version history is always intact and reviewable.
- Smart Document Linking: When a new version is uploaded (e.g., an updated investigator brochure or protocol), the system automatically links it across relevant folders and study records, while retiring outdated versions from view to avoid accidental use.
- Real-Time Access for Monitors: Instead of preparing version logs or printing binders for each visit, sites can grant read-only access to monitors, sponsors, or auditors, who see the most current files instantly without the manual prep. By eliminating the need to manually reconcile documents or cross-check spreadsheets, sites significantly reduce the risk of protocol deviations and inspection findings. Teams spend more time focused on clinical tasks and less time flipping through binders and catching up.
Bottom line: Site staff is always working from the right version, and you’ve got the audit trail to prove it.
The Impact of eReg/eISF on Your Site
Sites leveraging RealTime-eReg/eISF platform report measurable gains in efficiency, compliance, and cost savings. Key outcomes include:
- 5X faster inspection readiness through centralized access and real-time audit trails
- 75% reduction in monitoring visit costs by enabling remote access and reducing on-site needs
- 4X productivity boost by automating document workflows and reusing staff and site credentials
- 20% increase in study start-up speed thanks to standardized processes and real-time visibility
- 2X ROI in reduced monitoring and material costs compared to manual or paper-based systems
- Up to 60% reduction in time spent on document management tasks
- Fewer protocol deviations due to missing, outdated, or misfiled documents
Conclusion: eReg/eISF Improves Document Management
When your eClinical systems are built for transparency, traceability, and accountability, compliance becomes a competitive strength, not a stressor. In addition to wasting time, redundancy compromises quality, frustrates staff, and delays progress. By adopting a powerful eReg/eISF solution and fully integrating it into your workflows, your site can eliminate unnecessary repetition, boost compliance, and free your team to focus on patient care and study success. Whether you’re preparing for a routine audit or building a culture of quality, the right eClinical platform can help you do it faster, smarter, and with less risk.
Want a demo of how RealTime supports audit readiness and compliance best practices? Our experts are happy to walk you through it.
FAQs: How to Reduce Redundant Regulatory Work in Clinical Trials
Q: What are redundant regulatory tasks in clinical trials?
Redundant regulatory tasks include repetitive actions like printing and filing duplicate documents, chasing wet-ink signatures, manually updating delegation logs, and re-uploading the same credentials across multiple studies. These tasks increase workload, slow study start-up, and introduce compliance risk.
Q: How can eReg or eISF systems help eliminate redundancy in clinical trial documentation?
eRegulatory (eReg) and electronic Investigator Site File (eISF) systems centralize and automate regulatory processes. Features like master document libraries, digital signatures, version control, and automated alerts help clinical research sites avoid duplicate work and reduce human error.
Q: What features should a compliance officer look for in an eReg system?
Look for 21 CFR Part 11-compliant digital signatures, centralized credential and training libraries, automatic document versioning, audit-ready reporting, and real-time visibility into regulatory workflows across all active studies.
Q: How do eReg/eISF platforms improve inspection readiness?
Modern eReg systems ensure that all regulatory documents are current, traceable, and securely stored. During inspections, compliance officers can instantly show auditors time-stamped signatures, version histories, and complete training logs without searching through paper binders or multiple systems.
Q: Can an eReg system replace paper binders in clinical trials?
Yes. A 21 CFR Part 11-compliant eISF platform is designed to replace traditional paper regulatory binders. Sites that switch to eReg/eISF benefit from increased efficiency, faster audits, and more reliable compliance documentation.
Q: How do clinical trial sites manage credentials and training records more efficiently with eReg?
An eReg/eISF platform allows regulatory teams to upload credentials and training certificates once and apply them across multiple studies. Automated alerts notify teams of upcoming expirations, reducing compliance gaps and missed renewals.
Q: Is eReg considered a regulatory best practice for clinical research sites?
Yes. High-performing clinical research sites and site networks increasingly adopt eRegulatory platforms as a best practice. These systems help streamline compliance operations, reduce regulatory burden, and improve overall study performance.
Q: What compliance standards should an eReg system meet?
A compliant eReg system should support 21 CFR Part 11, HIPAA, and GDPR requirements, ensuring electronic records and signatures are secure, traceable, and legally valid.