Introduction Reconciliation and Literature Review and Signal Detection in Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods. Contact: "Katalyst Healthcares & Life Sciences" South Plainfield, NJ, USA info@KatalystHLS.com

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Reconciliation and Literature review and
Signal detection
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2. Definition of SAE reconciliation
 Serious adverse events data reconciliation is the comparison of key safety
data between two databases and/or between two or more
partners/CROs/MAHs.
 A clinical database is defined as a closed since it can receive data only for
a very short period of time that is the lasting of the trial (data lock).
 A safety database is defined as an open system since it continues to
receive new SAEs or updates of pre-existing SAEs concerning any clinical
trials even when they are locked.
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3. SAEs reconciliation occurs several
times during the whole study
period and it depends on:
1. The frequency of data receipt
and
2. The management of safety
updates from the PV to RA.
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Key safety data to be reconciled could be but not
limited to:
1. Subject ID and randomization number
2. Patient demographics
3. SAE verbatim
4. LLT term
5. PT term
6. SOC
7. Onset date
8. Stop date
9. Outcome
10. Severity
11. Seriousness criteria
12. Action taken and
13. Causality
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4. Cut-off point:
Often SAEs continues to be reported after a clinical trial has
ended, therefore it is important to define a cut-off point after
which no new SAEs or updates will be added to the clinical
database so that the process will be considered as closed for the
clinical database even if the safety database continue to receive
new SAEs or updates concerning that specific clinical trial.
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5. ICSR Reconciliation – SDEA Partners
 On a monthly basis, PV processing team shall provide a CIOMS II line listing to
Sponsor/MAH and to all appropriate partners of all individual case safety reports,
MIR and PQC that were received from and sent to all partners during the
preceding month.
 If an individual case safety report is not listed in the listing, partners shall promptly
resend this individual case safety report to PPV Hub.
 Likewise, if an individual case safety report is listed, but has not been received by
any of the partner (s), they shall promptly request PXL PPV that this individual case
safety report be forwarded to them from PPV Hub.
 This process will be considered to be closed and completed when the other party
confirms the receipt of all the cases listed in the cumulative listing.
 A Reconciliation tracker maintained in PMED to track & monitor the compliance.
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7. MIR examples
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8. Literature Searching and Review
• Literature search is designed to identify Individual Case Safety Reports (ICSRs) and safety
signals
• Search applicable databases (Ex: Medline, Embase) on a weekly basis as per established
literature search strategy for Trade name or active ingredient. SDEA partners will conduct
local literature searching for the designated territory. The valid articles were send to the
project specific mail box.
• Process steps:
STN automated search output are received in PV mailbox
Review by PV team and order full text article for relevant abstracts (reporting rules)
DSP review of full text articles
Processing of valid ICSR
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