8 ICH E6(R3) Data Governance Requirements That Apply to Your CTMS and eTMF

ICH E6(R3) gives data governance its own section. Annex 1, Section 4, "Data governance: investigator and sponsor", covers safeguarding blinding, the elements of the data life cycle and computerised systems (ICH E6(R3), EMA Step 5). EMA's separate guideline on computerised systems and electronic data in clinical trials covers the same ground in more detail: validation, user management, security and electronic data across the data life cycle (EMA guideline).

Most discussion of Section 4 focuses on EDC and eCOA, the systems that hold participant data. But CTMS and eTMF hold the records that show how the trial was run and overseen, and inspectors read them. The eight requirements below apply to both, with the level of control proportionate to the importance of the data.

The requirements at a glance

1. Systems are fit for purpose and stay validated

The responsible party should make sure computerised systems are validated for their intended use, proportionate to risk, and that validation is maintained throughout the system's life cycle, not only at go-live. For CTMS and eTMF, that means validation evidence for configured workflows, not just the vendor's base product.

2. Metadata and audit trails are kept with the data

The audit trail is part of the record. Exports or migrations that carry documents or data without their metadata lose the evidence of who did what and when.

3. Audit trails are reviewed, not just retained

E6(R3) expects review of data and relevant metadata. That requires audit trails a person can read, filtered to the changes that matter, such as edits to monitoring findings or replacement of approved documents.

4. Corrections are attributable and explained

When a deviation record, monitoring report or filed document is changed, the system should show who made the change, when, and why, without hiding the original.

5. User access is managed throughout the trial

Access should match each person's role, study and, where relevant, blinding status. Joiners, leavers and role changes are part of GCP compliance, because an account left open after someone leaves is an access-control finding.

6. Systems are secure and recoverable

Security controls, backup and disaster recovery should be in place and tested, proportionate to the importance of the records the system holds.

7. Transfers and migrations keep the record intact

Moving a study from one system to another, or transferring a TMF from a CRO to a sponsor, must keep documents, metadata and audit trails together and verify that nothing was lost.

8. Records stay retrievable for the retention period

Archived records and their metadata must remain readable and protected from unauthorised change for as long as they must be kept. For the EU TMF, that is at least 25 years.

Data governance checklist for CTMS and eTMF

• Validation evidence for configured workflows, with periodic review
• Audit trails that can be filtered and read by reviewers
• A defined schedule for reviewing audit trails on critical records
• Reason-for-change captured on corrections
• Role-based access, with joiner and leaver checks
• Blinded and unblinded access separated where needed
• Backup and recovery tested
• Migration and transfer verification documented
• Archive retrieval tested

What this means by role

• Quality and compliance directors and QA auditors: CTMS and eTMF belong in your computerised system inventory and audit trail review plan.
• eTMF managers and directors: document replacement and approval history is the audit trail inspectors read first.
• Clinical operations directors: monitoring and deviation records in CTMS are evidence of oversight, and need the same controls.
• Clinical data managers: the same Section 4 principles you apply to EDC apply to the systems around it.

How Cloudbyz approaches this

Cloudbyz CTMS and eTMF are built natively on Salesforce, so platform controls such as role-based and field-level security, audit trails, encryption and event monitoring are available to both. Cloudbyz describes its products as compliant with 21 CFR Part 11 and aligned with GxP and GAMP 5, and holds ISO 27001 certification. eTMF supports QC and approval workflows with electronic signatures and export with metadata and audit trail. Validation scope, audit trail review and access rules still need to be defined and documented by each sponsor or CRO for its own use, proportionate to risk.

See data governance in practice

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