This is a ready-to-use log for tracking who has legitimate access to unblinded interim trial data across the life of a study, so the firewall between the DSMB’s unblinded world and the sponsor’s blinded study team can be demonstrated, not just asserted. Replace every <<FILL: ...>> placeholder with your own specifics, set your document number, and route it through your normal document control. A filled sample row follows. Verify each cited regulation against the current source before you rely on it.
Purpose
The log answers one question an inspector or auditor will ask directly: “give me the list of everyone who could see unblinded data on this trial, and show me none of them are on the blinded study team.” A DSMB charter and meeting minutes describe the process; this log is the running roster that proves the process held at every point in time, not just at the moments someone happened to check.
Field table
| Field | Format | Required | Who completes | When |
|---|---|---|---|---|
| Study / protocol number | Text | Yes | Log administrator | At log opening |
| Individual name and role | Text | Yes | Log administrator | On access grant |
| Organization | Text | Yes | Log administrator | On access grant |
| Basis for access | DSMB member / independent unblinded statistician / statistical data analysis center / unblinded safety desk / other (state) | Yes | Log administrator | On access grant |
| Systems / data granted | Text, naming the specific unblinded environment, dataset, or report | Yes | Log administrator | On access grant |
| Grant date | Date | Yes | Log administrator | On access grant |
| Confirmed not a blinded study-team member | Yes / No, with cross-check evidence reference | Yes | Clinical QA or independent reviewer | On access grant and at each periodic review |
| Revoke date | Date, or “active” | Yes | Log administrator | On access removal |
| Reason for revoke | Text (role ended, study closed, reassigned) | Conditional | Log administrator | On access removal |
| Periodic review date and reviewer | Date, name | Yes | Clinical QA | At each defined review interval |
Instructions
- Open the log at DSMB charter approval, before the first interim look, and add every individual granted unblinded access at that time.
- Add a new row the moment a new individual is granted access; do not batch entries after the fact.
- Before adding anyone, cross-check the name against the current sponsor blinded study-team roster and record the confirmation. A name appearing on both lists is a firewall breach, not a data entry error, and must be escalated the same day.
- Record a revoke date the day access actually ends, not the day the paperwork catches up.
- At each periodic review (recommended: at every interim look and at least annually for long-running trials), re-confirm every active entry against the current blinded-team roster and sign the review.
- Retain the log per the records retention schedule, for not less than
<<FILL: retention period>>, alongside the DSMB charter and meeting records.
Retention
<<FILL: retention period and location, e.g. retained in the study's DSMB independent record, not the sponsor's blinded trial master file, for the life of the trial plus the applicable regulatory retention period>>.
Filled sample row
The following shows one completed entry, so you can see the level of detail expected. Details are illustrative.
| Field | Entry |
|---|---|
| Study / protocol number | CVOT-2026-014 |
| Individual name and role | Prof. T. Andersson, independent unblinded statistician |
| Organization | Independent Statistical Data Analysis Center, <<FILL>> |
| Basis for access | Independent unblinded statistician |
| Systems / data granted | Unblinded interim analysis environment, treatment-assignment dataset |
| Grant date | 02 March 2026 |
| Confirmed not a blinded study-team member | Yes; cross-checked against sponsor blinded roster BR-2026-014 v3, confirmed by M. Alvarez, 02 March 2026 |
| Revoke date | Active |
| Reason for revoke | N/A |
| Periodic review date and reviewer | 12 August 2026, M. Alvarez (confirmed still not on blinded roster) |
Common inspection findings this log prevents
- No documented list of who actually had unblinded access, so the sponsor can only assert the firewall held rather than demonstrate it.
- An individual’s access recorded but never cross-checked against the blinded study-team roster.
- Access still marked active for someone who left the unblinded role months earlier.
- Periodic reviews that do not exist, so a roster drift (a blinded team member added to a shared system by mistake) goes undetected for the life of the trial.
How to adapt this log
- Set your document number and retention period in the header fields.
- If your program uses a standing DSMB across multiple studies, add a study/protocol column exactly as shown so one log can serve the whole program without losing per-study traceability.
- Point the cross-check step at your actual blinded-team roster source, whether that is an HR system, a delegation log, or a study team list maintained by clinical operations.
- Set your periodic review interval to match the interim analysis schedule in the DSMB charter.