Governance and oversight
1) Oversight structure
Oversight is designed to balance operational efficiency with independent governance and transparent decision making.
Registry Governance Team: accountable for policy, integrity, and platform stewardship.
Standards and Policy Panel: maintains data standards, required fields, and guidance documents.
Integrity and Disputes Panel: reviews concerns, corrections, withdrawals, and exceptional removals.
Security and Privacy Oversight: monitors privacy safeguards, data retention, and incident response.
Technical Operations: responsible for uptime, backups, access control, and change management.
2) Roles and responsibilities
Clear responsibilities support consistent decisions and reduce conflicts of interest.
Submitters: ensure records are accurate, complete, current, and non-identifying.
Administrators: perform completeness checks, manage publication workflows, and enforce policies.
Reviewers (where used): assess consistency and policy alignment, not scientific merit.
Governance leads: approve standards changes, adjudicate disputes, and oversee integrity processes.
Security officers: manage access, logging, monitoring, and incident escalation.
3) Independence and conflicts of interest
Decisions affecting the public record require independence, consistency, and transparent handling of conflicts.
Disclosure: governance members disclose relevant professional, financial, or academic interests.
Recusal: members do not participate in decisions where a conflict exists or could reasonably be perceived.
Documentation: key decisions are documented with rationale and linked to the applicable policy.
Consistency: similar cases are treated similarly, with policy updates when gaps are identified.
4) Record integrity: corrections, withdrawals, and removals
The Clinical Register prioritizes correction and versioning to preserve a citable, auditable record.
Correction: factual errors are corrected through an amended version.
Withdrawal: displayed as a status change when a study is stopped or should no longer recruit; prior versions remain.
Exceptional removal: limited to unlawful content, serious safety concerns, or privacy violations; may leave a minimal “tombstone” record.
Misuse and fraud: suspected misconduct may trigger enhanced review, temporary restriction, or referral to relevant institutions.
5) Complaints, disputes, and appeals
We apply due process for concerns about accuracy, authorship, ethics status, privacy, or inappropriate content.
Submission: provide the Registration ID, concern type, and supporting documentation.
Triage: we assess urgency (for example, privacy or safety) and apply interim actions if needed.
Review: the Integrity and Disputes Panel evaluates evidence and requests clarification from relevant parties.
Decision: outcomes may include correction, status change, restriction, or exceptional removal with a documented rationale.
Appeal: a separate reviewer or panel member not involved in the initial decision reviews the appeal.
6) Security, privacy, and risk management
Oversight includes practical controls to protect the platform and prevent disclosure of personal or sensitive information.
Access control: role-based permissions and least-privilege administration.
Logging: security and administrative actions are logged and reviewed.
Incident response: defined escalation pathways for suspected breaches or misuse.
Privacy safeguards: submissions must exclude personal identifiers and participant-level data.
Change management: updates to standards and platform features follow documented review processes.
7) Policy updates and transparency
Policies evolve. Updates are documented and dated to support clarity and consistency.
Review cycle: policies are reviewed periodically and updated when standards or requirements change.
Change log: material updates include a “last updated” date and summary of changes.
Public clarity: governance principles and key policies remain publicly accessible.
8) Contact governance
Contact the governance team for integrity concerns, disputes, appeal requests, or questions about standards.