Log: Pharmacovigilance Case Reconciliation

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.

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.

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