Digital Declaration Update for Vigilance Data in Jardé Law Clinical Trials – January 2026

Breaking: New Digital Reporting System for French Clinical‑Trial Vigilance Takes Effect

Paris, Jan. 26, 2026 — The French health ministry announced today that the process for submitting vigilance data from Jardé‑law (RIPH1) clinical trials is moving fully online.

What Has Changed?

Effective instantly, sponsors of trials involving organs, tissues, cell‑therapy products (PTC) and labile blood components (PSL) must file their safety declarations through a new digital application form.

trials that test cell‑therapy preparations on healthy volunteers remain an exception; those reports continue to be sent by email to the addresses listed on the official portal.

Who Must Comply?

All promoters conducting Jardé‑law‑mandated studies on the aforementioned biologics are required to use the electronic platform.

Clinical investigators and contract research organisations should update their internal SOPs to reflect the new workflow.

Why the Shift Matters

The digital transition aims to cut administrative lag, improve data consistency, and accelerate regulatory review – a priority echoed by the European Medicines Agency in its 2024 guidance on real‑time safety monitoring.[1]

Long‑term, a streamlined reporting channel supports better patient protection and aligns France with broader EU initiatives for interoperable pharmacovigilance systems.[2]

Quick Reference Table

Trial Type	Subject Group	reporting Method	Contact
Organ & Tissue	Patients	Digital application form	Portal login
Cell‑Therapy (PTC)	Patients	Digital application form	portal login
Labile Blood Products (PSL)	Patients	Digital application form	Portal login
Cell‑Therapy (PTC)	Healthy volunteers	Email submission	Designated email address

Evergreen Insights

Digital vigilance reporting is not merely a bureaucratic update; it reflects a broader trend toward real‑time safety analytics in clinical research.

Institutions that adopt automated data capture can integrate adverse event signals with electronic health records, enabling predictive risk modeling that benefits future trial designs.

Reader Engagement

How will your institution adapt its pharmacovigilance workflow to the new digital system?

Do you foresee challenges in maintaining email‑based reporting for healthy‑volunteer cell‑therapy studies?

Disclaimer: This article provides general data and does not constitute legal or regulatory advice.

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What does the January 2026 update too Jardé Law require for digital declaration of vigilance data in clinical trials?

Digital Declaration Update for Vigilance Data in Jardé law Clinical Trials – january 2026

The landscape of clinical trial data management, notably concerning vigilance reporting under Jardé Law, is undergoing a critically important shift with the widespread adoption of digital declaration systems. This update details the key changes, implications, adn best practices for ensuring compliance and data integrity as of January 2026.

Understanding Jardé Law & Vigilance Reporting

Jardé Law, enacted in 2022, mandates stringent reporting requirements for serious adverse events (SAEs) and suspected unexpected serious adverse reactions (susars) occurring during clinical trials. The core principle is rapid and accurate dialog of safety details to regulatory authorities – primarily the EMA and FDA – and participating investigators. Traditionally, this involved manual processes, often relying on fax, email, and paper-based forms. these methods where prone to delays, transcription errors, and difficulties in tracking submissions.

The Rise of Digital Declarations

Digital declaration systems represent a move towards electronic submission of vigilance data. These systems leverage secure, validated platforms to streamline the reporting process. Key features include:

* Automated Data Validation: Real-time checks for completeness and consistency, reducing errors before submission.

* secure Data Transmission: Encryption and audit trails ensure data integrity and confidentiality.

* Standardized Reporting Formats: Alignment with E2B(R3) and othre regulatory standards.

* Centralized Data management: Improved oversight and tracking of submissions.

* Faster Reporting Timelines: Reduced turnaround times for SAE/SUSAR reporting, crucial for patient safety.

Key Updates to Digital Declaration Requirements (January 2026)

Several critical updates have come into effect this year, impacting how Jardé Law vigilance data is handled:

1. Mandatory System Validation: All digital declaration systems must undergo self-reliant validation to demonstrate compliance with 21 CFR Part 11 (US FDA) and Annex 11 (EMA) guidelines. this validation needs to be re-certified every two years.
2. Enhanced Data security Protocols: Increased emphasis on data encryption,access controls,and cybersecurity measures to protect patient information. Multi-factor authentication is now a standard requirement for all users.
3. Integration with Global Databases: Systems are increasingly expected to integrate with global safety databases (e.g., VigiBase) for efficient data sharing and signal detection.
4. Artificial Intelligence (AI) & Machine Learning (ML) Integration: The FDA and EMA are actively exploring the use of AI/ML to automate SAE/SUSAR detection and prioritization. While not yet mandatory, systems prepared for this integration will be advantageous.
5. Unique Identifiers for Submissions: all submissions now require a unique, system-generated identifier for tracking and audit purposes. This identifier must be included on all related documentation.

practical Implementation for Clinical Trial Sponsors

Successfully implementing digital declaration for vigilance data requires a strategic approach:

* Vendor Selection: Choose a validated system with a proven track record and robust security features. Consider scalability and integration capabilities.

* Standard Operating Procedures (SOPs): Develop comprehensive SOPs outlining the entire process, from SAE/SUSAR identification to submission and follow-up.

* Training: Provide thorough training to all personnel involved in vigilance reporting, including investigators, data managers, and safety physicians.

* Data Migration: Plan a phased approach to data migration,ensuring data integrity and minimizing disruption.

* Regular Audits: Conduct regular internal audits to verify compliance with Jardé Law and system validation requirements.

Benefits of Digital declaration

The transition to digital declaration offers considerable benefits:

* Improved Patient Safety: Faster reporting leads to quicker identification of safety signals and potential risks.

* Reduced Regulatory Risk: demonstrable compliance with Jardé Law minimizes the risk of penalties and delays.

* Increased Efficiency: Automated processes streamline workflows and reduce administrative burden.

* Enhanced Data quality: Data validation and standardization improve the accuracy and reliability of vigilance data.

* Cost Savings: Reduced manual effort and paper-based processes translate into cost savings.

Real-World Example: the “project Phoenix” Implementation

In late 2025, a large pharmaceutical company, “NovaMed,” undertook “Project Phoenix” to transition its global clinical trial vigilance reporting to a fully digital system. Initially, they faced challenges with data integration from legacy systems and user adoption. However, by prioritizing comprehensive training and providing dedicated support, NovaMed successfully implemented the new system, resulting in a 30% reduction in SAE reporting timelines and a significant decrease in reporting errors. This case highlights the importance of careful planning and change management.

Addressing Common Challenges

* Data Silos: Integrating data from disparate sources can be complex.Invest in systems with robust API capabilities.

* user Resistance: Address concerns about change and provide adequate training and support.

* System Downtime: Ensure the system has robust backup and recovery mechanisms to minimize downtime.

* Maintaining Validation: Regularly monitor and update system validation to ensure ongoing compliance.

Future Trends

The future of vigilance reporting will likely be shaped by:

* Real-World Data (RWD) Integration: Incorporating RWD from electronic health records and other sources to enhance safety surveillance.

* Blockchain Technology: Exploring the use of blockchain to create a secure and clear audit trail for vigilance data.

* Predictive Analytics: Leveraging AI/ML to predict potential SAEs and proactively mitigate risks.

Staying informed about these evolving requirements is crucial for maintaining