Guardian PV Engine — Complete Pharmacovigilance Lifecycle
Full pharmacovigilance processing engine: ICSR validation (CIOMS I/II 4-element rule), causality assessment (Naranjo 10-question scale, WHO-UMC 6-category, RUCAM hepatotoxicity), seriousness classific
10 toolspv-engine
Assess Naranjo
Run the Naranjo Adverse Drug Reaction Probability Scale. Scores 10 questions about temporal relationship, dechallenge, r
q1_previous_reportsq2_temporal_relationshipq3_dechallengeq4_rechallengeq5_alternative_causesq6_placebo_responseq7_drug_concentrationq8_dose_responseq9_previous_experienceq10_objective_evidence
Assess Who Umc
Assess causality using the WHO-UMC system. Evaluates temporal relationship, dechallenge/rechallenge, and alternative cau
time_relationshipdechallengerechallengealternative_causes
Classify Seriousness
Classify adverse event seriousness using ICH E2A criteria. Checks 7 regulatory criteria: death, life-threatening, hospit
event_description
Determine Expedited Reporting
Determine expedited reporting type and deadline per ICH E2A/E2D and regional requirements. Evaluates seriousness, expect
is_seriousis_unexpected
Calculate Submission Deadline
Calculate regulatory submission deadline from Day 0 (awareness date). Per ICH E2D(R1), Day 0 = date minimum information
awareness_datereport_type
Calculate Psur Interval
Calculate PSUR/PBRER reporting interval from International Birth Date (IBD). ICH E2C(R2) standard intervals: Years 1-2:
international_birth_date
Calculate Dsur Cutoff
Calculate DSUR (Development Safety Update Report) data lock point and submission deadline. ICH E2F: annual report during
development_ibd
Validate Icsr Minimum
Validate ICSR against ICH E2B(R3) minimum data requirements. The 4-element rule: (1) identifiable reporter, (2) identifi
no params
Check Deadline Compliance
Check if a case submission was within the regulatory deadline. Returns compliance status with days used, days over, and
awareness_datesubmission_datereport_type
List Capabilities
List all Guardian PV Engine capabilities with their namespaces, parameter signatures, and regulatory references. Use thi
no params