Panel · Use case · Pharmacovigilance

Safety Signal Investigation Order.

LivePrioritisation Panel

Rank these 10 open safety signals by how soon we should investigate them.

Items10 open safety signals

SeatsSafety, medical information, regulatory, quality

ReaderSafety leads

Not askedA signal assessment

DepthStandard, four seats

Safety Signal Investigation Order is a ready-made use case for Pharmacovigilance. It ships under the Prioritisation Panel template.

For drug safety leads. You get each seat's ranking, the aggregated list with a cut line, where the seats disagree and how stable the line is. Claims are cited or marked as gaps.

Add it to your library to reuse from New → From template. Edit the saved copy in your library on the service form.

The decision

Rank these 10 open safety signals by how soon we should investigate them.

Who ranks

EU rules set out how signals are validated, prioritized and assessed. Priority depends on seriousness, strength and the likelihood of an impact on public health.

Seat	What it ranks from	Why it is at the table
Head of Pharmacovigilance	Seriousness, strength of evidence and novelty of each signal.^{1European Medicines Agency. Guideline on good pharmacovigilance practices (GVP): Module IX – Signal management (Rev. 1). EMA/827661/2011 Rev. 1.}	GVP Module IX.
Medical Information Services Master	How many enquiries touch each signal and what prescribers are asking.	Enquiry data.
Regulatory Strategist	Which signals carry a regulatory clock or are likely to be raised by an agency.^{1European Medicines Agency. Guideline on good pharmacovigilance practices (GVP): Module IX – Signal management (Rev. 1). EMA/827661/2011 Rev. 1.}	Agency practice.
Director Quality Assurance	Whether quality or manufacturing issues could explain a signal.	Quality records.

What the run does

Priority is not validity. A signal ranked high is investigated first. It is not thereby confirmed. The report keeps the two apart.^{1European Medicines Agency. Guideline on good pharmacovigilance practices (GVP): Module IX – Signal management (Rev. 1). EMA/827661/2011 Rev. 1.}

Reports are not rates. Disproportionality in spontaneous reports is a pointer. The report ranks on strength and seriousness and does not turn counts into risk.^{2Evans, S. J. W., Waller, P. C. and Davis, S. Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. Pharmacoepidemiology and Drug Safety, 2001;10(6):483–486.}

Clocks override. A signal with a regulatory deadline is placed above the cut line whatever its rank, and the report says so.

Recommended length

Standard

Four angles weigh the list differently. Standard depth gives each a seat, with disagreement, value versus effort and sensitivity, in about four pages.

You can pick another length on the form. The other two stay available.

Assumptions the run makes

The run states the assumptions behind its criteria and its cut line, and says what each gap limits. Examples for this list:

The 10 signals are distinct and not different views of one event.
Case counts are current and de-duplicated.
No signal is already known to the agency.

Standards, guidance and sources

Frame

EMA, GVP Module IX: Signal management (Rev. 1).^{1European Medicines Agency. Guideline on good pharmacovigilance practices (GVP): Module IX – Signal management (Rev. 1). EMA/827661/2011 Rev. 1.}
Evans, Waller and Davis, proportional reporting ratios, 2001.^{2Evans, S. J. W., Waller, P. C. and Davis, S. Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. Pharmacoepidemiology and Drug Safety, 2001;10(6):483–486.}

The decision practice behind the memo itself is on the template page.

What gets flagged

Any signal ranked from counts alone, any signal with a regulatory deadline, and any pair of signals that may be one event.

What arrives

The question, criteria and items
The cut line and the top group
How each seat ranked
The aggregated ranking
Where the seats disagree
Value versus effort
Sensitivity of the cut line
Limits and what would change the ranking

What it will not do

The agreement is a simulation by AI specialists and not a panel of real experts. The criteria are fixed before ranking, and the cut line is a recommendation that the decider can move.

It does not decide whether a signal is validated. That belongs to the safety committee.

It is a simulation by AI specialists and not a panel of real experts. Seats that share a base model are not independent confirmations of each other.

It does not compute a value-of-information analysis. That needs a decision model. It ranks by proxies and says so.

It does not set the weights for you. If none are supplied, the criteria are weighted equally and the report says so.

References

[1] European Medicines Agency. Guideline on good pharmacovigilance practices (GVP): Module IX – Signal management (Rev. 1). EMA/827661/2011 Rev. 1. Scope as given in EMA’s listing; not read in full.
[2] Evans, S. J. W., Waller, P. C. and Davis, S. Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. Pharmacoepidemiology and Drug Safety, 2001;10(6):483–486. Abstract only.

Links checked 9 October 2026

These are the sources the template drew on. None of their authors or issuers has reviewed it.

About the Panel service

Each panelist answers in their own voice, then the discussion is drawn together. You get the question and who was in the room, every position in full, what they agreed on, where they split, and what follows. Disagreements are written down rather than smoothed into a consensus nobody actually holds, because the split is usually the part you needed.

To edit a saved template, open New → Panel → From template, or the library rail on the service form.