This is a ready-to-use log for periodic pharmacovigilance case reconciliation across the sources safety data can arrive from: the clinical trial database, license partners under a Safety Data Exchange Agreement (SDEA), and health authority submission acknowledgments.
Replace every <<FILL: ...>> placeholder, run it on a fixed calendar, and retain the sign-off even when nothing is found. This content is educational reference, not legal or regulatory advice.
Header
| Field | Entry |
|---|---|
| Reconciliation ID | <<FILL: LOG-ID>> |
| Product(s) in scope | <<FILL>> |
| Reconciliation type | <<FILL: Clinical-vs-safety / Partner-vs-safety / Submission ACK / combined>> |
| Period covered | <<FILL: from date>> to <<FILL: to date>> |
| Performed by | <<FILL: name, role>> |
| Date performed | <<FILL>> |
Field definitions and instructions
| Field | Format | Required | Who | When |
|---|---|---|---|---|
| Source system count | Integer | Yes | Reconciliation owner | At each reconciliation |
| Safety database count | Integer | Yes | Reconciliation owner | At each reconciliation |
| Discrepancy count | Integer (calculated) | Yes | Reconciliation owner | At each reconciliation |
| Discrepancy detail | Free text, one row per case | Yes, if discrepancy count > 0 | Reconciliation owner | At each reconciliation |
| Root cause | Free text | Yes, for every discrepancy | Investigator | Before closure |
| Resolution / corrective action | Free text | Yes, for every discrepancy | Investigator | Before closure |
| Sign-off | Name, signature, date | Yes | QA or PV quality | After every reconciliation, including zero-discrepancy ones |
Retain each reconciliation record for <<FILL: retention period, per your records retention schedule>>.
Reconciliation record
A. Clinical trial database vs safety database
| Field | Entry |
|---|---|
| Trial / EDC system | <<FILL>> |
| SAE count in EDC for period | <<FILL>> |
| ICSR count in safety database for period | <<FILL>> |
| Discrepancy | <<FILL: number and case IDs>> |
| Root cause | <<FILL>> |
| Resolution | <<FILL>> |
B. License partner vs safety database (per SDEA)
| Field | Entry |
|---|---|
| Partner name | <<FILL>> |
| SDEA reference | <<FILL>> |
| Cases partner was obligated to send | <<FILL>> |
| Cases received and processed | <<FILL>> |
| Discrepancy | <<FILL>> |
| Root cause | <<FILL>> |
| Resolution | <<FILL>> |
C. Submission vs acknowledgment
| Field | Entry |
|---|---|
| Gateway / authority | <<FILL: e.g. FAERS, EudraVigilance>> |
| Cases submitted for period | <<FILL>> |
| Positive acknowledgments received | <<FILL>> |
| Negative / missing acknowledgments | <<FILL>> |
| Resolution (retransmission, correction) | <<FILL>> |
Acceptance criteria
- Every source count is pulled from the source system directly, not from a memory or an intermediate summary.
- Every discrepancy is investigated to root cause; “close enough” or an unexplained variance is not an acceptable closure.
- Zero-discrepancy reconciliations are still documented and signed; the absence of a record is itself a finding.
- The reconciliation runs on the defined calendar; a missed or late reconciliation is logged as a deviation.
Signoff
| Role | Name | Signature | Date |
|---|---|---|---|
| Reconciliation owner | <<FILL>> | ||
| PV quality / QA | <<FILL>> |
References
EU GVP Module VI (case management) and Module I (PV system, quality). ICH E2D(R1), Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports. Company Safety Data Exchange Agreement(s) per product / partner.
Confirm the current version of each reference before issue.
Filled specimen
A completed clinical-vs-safety reconciliation for an example ongoing study. Illustrative only.
| Field | Entry |
|---|---|
| Trial / EDC system | Study ABC-302, EDC platform |
| SAE count in EDC for period | 142 |
| ICSR count in safety database for period | 140 |
| Discrepancy | 2 cases (subject IDs 0312-011, 0347-004) |
| Root cause | Both SAEs entered in the EDC on the last day of the quarter, one hour after the safety database extract had already run for the period |
| Resolution | Both cases confirmed already created in the safety database the following morning and within their individual 15-day clocks; extract cutoff time realigned with the EDC cutoff in the reconciliation SOP so the timing gap does not recur |
The gap here was a timing artifact, not a lost case, but it was investigated to that conclusion rather than assumed. That is what separates a defensible reconciliation from a rubber stamp: the record shows the two cases were checked individually against their own reporting clocks before the discrepancy was closed.
Common inspection findings this log prevents
- No documented reconciliation between the clinical trial database and the safety database for an ongoing study.
- A discrepancy is noted but closed with no stated root cause.
- Zero-discrepancy periods have no record at all, so the reconciliation cannot be shown to have happened.
- A negative or missing submission acknowledgment was never followed up or retransmitted.
How to adapt this log
- Set the product, period, and reconciliation type in the header.
- Add a section for any additional source your organization actually operates (a registry, a market research vendor, a patient support program).
- Run this on a fixed calendar with a named owner, and retain zero-discrepancy records the same as records with findings.
- Confirm every regulation in the references against the current published version before issue.