Definition

An adverse event report obtained through organized data collection systems such as clinical trials, registries, patient support programs, or active surveillance programs.

Example

During a Phase III clinical trial, a patient reports headache during a scheduled follow-up call. This is solicited because it was collected as part of an organized protocol.

Regulatory source

ICH E2D Section 2.2

Common mistakes

Treating all patient support program reports as spontaneous. If the program involves active follow-up or questionnaires, reports are typically solicited.

Inspector question

Describe your process for determining whether a report from a patient support program should be classified as solicited or spontaneous.

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