A solicited report is a report of an adverse event or a suspected medicinal product reaction from an organised data collection system. In other words, the report is collected within a pre-established programme, registry, survey, or study and is not submitted unsolicited. For pharmacovigilance, it is classified as a study report and requires a causality assessment.
Organised systems as the source of the information
The term refers to how the information was obtained, not to its medical seriousness. ICH E2D cites clinical trials, registries, named-patient programmes after approval, patient support programmes, and disease management programmes as examples. Patient or healthcare professional surveys, as well as data collection on effectiveness or treatment adherence, can also generate solicited reports.
What these sources have in common is a predefined structure: participation, data capture, or contact follows a plan. This may be a trial protocol, a registry protocol, a standardised questionnaire, or a programme workflow. This makes it traceable why the person concerned was contacted and which information was intended to be systematically requested or collected.
During data entry, a solicited report may initially look like an individual case report. However, its classification must not be derived solely from the form used. What matters is whether the information was generated by the organised system. This origin determines the safety classification and the subsequent medical assessment.
Causality assessment as a processing step
For this type of report, ICH E2D requires a substantiated review of the possible relationship to the medicinal product by qualified personnel or the marketing authorisation holder. Only if one of these parties affirms a possible relationship is the observation from the organised source classified as a medicinal product reaction. The assessment considers, for example, temporal relationship, alternative explanations, concomitant therapy, dechallenge, and available clinical findings.
This requirement does not mean that every observation documented in the programme is considered a confirmed reaction. Rather, it creates a traceable step between collecting an adverse event and classifying it as a suspected adverse reaction. The assessment must therefore be documented in the case with its rationale, available data, and, where applicable, later re-assessment.
In periodic safety reports, solicited non-interventional sources are evaluated separately from spontaneous sources. GVP Module VII lists, among others, non-interventional studies and other solicited sources. Interventional studies are not assigned to this group in this presentation because separate requirements apply to their collection and safety reporting.
Boundary: Not a spontaneous report, but a study report
A solicited report is not a spontaneous report. In spontaneous reporting, the information reaches the company, the authority, or another body without an underlying organised collection scheme. If, by contrast, a person is contacted as part of a registry, a patient programme, or a survey, classification as a solicited report is likely.
This distinction affects causality: for spontaneous reports on authorised medicinal products, the suspected relationship is generally assumed by virtue of the reporting route. For solicited reports, the causality assessment must be performed explicitly. The term is therefore not merely a description of the intake channel, but a requirement for the assessment step.
In the ICH catalogue, a clinical trial is an example of an organised source. Nevertheless, clinical trial safety reporting processes must not be mixed with spontaneous post-marketing reporting. The existing entry on spontaneous reporting and this entry therefore deliberately form a contrasting pair: one classifies unsolicited communications, the other information from systematically structured data collection.
Relevance for clinical trials
In clinical trials, solicited information arises at many points: at visits, in the electronic case report form, in patient questionnaires, in registries, or in accompanying programmes. The trial team and the safety department must define in advance how events are collected, when they are medically assessed, and how results are forwarded to the sponsor and authorities. Incomplete causality information or incorrect assignment as a spontaneous report can delay appropriate individual case processing.
Full-service CROs such as Mediconomics support solicited reports with safety management plans, clear data flows between the trial site, data management, and pharmacovigilance, and medical review of causality information. They can align data collection forms for registries and support programmes, coordinate follow-up queries, and ensure that cases assessed as relevant are transferred into the intended safety process.
Frequently Asked Questions (FAQ)
Is every report from a patient support programme solicited?
If the programme constitutes an organised system for data collection or contact, the reports obtained there are treated as solicited. The specific design of the programme and the reporting pathway must be reviewed.
Why does a solicited report require a causality assessment?
The programme also captures observations that were not necessarily caused by the medicinal product. The assessment therefore distinguishes an adverse event from a potentially product-related reaction.
Is a registry report automatically serious?
No. Originating from a registry defines the reporting type. Seriousness, expectedness, and other criteria are assessed independently for the individual case.
Regulatory References
- ICH E2D, Post-Approval Safety Data Management – classifies organised sources as solicited reports.
- ICH E2A, Clinical Safety Data Management – sets out principles for expedited safety reporting in studies.
- GVP Module VII, Periodic Safety Update Report – distinguishes solicited non-interventional and spontaneous data sources.
- Regulation (EU) No 536/2014 – governs the European framework for clinical trials.