Individual Case Safety Report Processing Record
Case-processing record built around the decision that actually gets cited in findings: day zero and how awareness is evidenced. Covers minimum criteria, seriousness and expectedness against a named labelling version, coding with dictionary versions, follow-up attempts, and per-authority submission with acknowledgements. Maps to ICH E2A, E2B(R3) and E2D(R1).
What a template is not
A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.
An Individual Case Safety Report is the atomic unit of pharmacovigilance: one patient, one or more suspected adverse reactions, one reporting obligation with a clock attached. The hard part is not the form — it is deciding the day zero from which the clock runs and defending that decision months later, because day zero depends on when your organisation first held the information, not when the case file was opened.
What's Inside
How to Use It
The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.
ICH E2A defines expedited reporting with the seriousness and expectedness concepts, ICH E2B(R3) the electronic transmission format, ICH E2D(R1) post-approval awareness and day zero, and EU GVP Module VI the collection and submission of individual case safety reports for EU-authorised products. None of them decides when your particular organisation became aware, or which internal receipt counts — that determination is yours and rests on the intake records you keep. The record structure is SPEQ’s practitioner synthesis.