Safety Programming & Pharmacovigilance
Reconcile, monitor and communicate risk without breaking the blind
Support SAE reconciliation, aggregate safety review, committees, narratives and safety reporting with governed data cuts.
Clinical data, safety-system cases, exposure, coding dictionaries and reporting calendar
Reconciled safety data, committee packages, aggregate-report feeds and narrative datasets
Real course content
6 chapters
Each chapter contains instructional sections, a CLIN-301 worked workflow, failure modes, a concrete deliverable, and an assessment.
The safety data landscape
Clinical DB vs safety (PV) DB, the MedDRA hierarchy, WHODrug, and expedited vs aggregate reporting.
Chapter 1 of 6
SAE processing & reconciliation
A core programming responsibility: case flow in the safety system and building a reconciliation listing.
Chapter 2 of 6
DMC / DSMB deliverables
The role of a Data Monitoring Committee, open vs closed reports, unblinded programming and firewalls.
Chapter 3 of 6
Safety Review Committees (SRC) & signal detection
SRC/IDMC distinctions, dose-escalation reviews, signal-detection outputs, cumulative displays.
Chapter 4 of 6
Aggregate safety reports
How programming feeds DSUR and PBRER/PSUR: cumulative and interval tabulations, SAE line listings, SUSARs.
Chapter 5 of 6
Deaths, SAEs & narratives feed
Death and SAE listings, data for patient narratives, traceability from AE to narrative, and QC.
Chapter 6 of 6