Table 3.

Recommended checklist for the aerobiological part in AITs and clinical trials. All issues have to be addressed and considered during the planning of a trial in order to grant success and higher comparability of such studies.

Checklist categories	Checklist points
Site selection	•Exposure is relevant to the selected aeroallergen in the concerned country/region •Exposure to the relevant selected aeroallergen is not significantly overlapped by another aeroallergen of importance •Impact of cross-reactivity of other pollen types has to be considered
Pollen season definition	•Pollen season definition is clearly described •Pollen season definition is applicable to the chosen site/region •Pollen season definition considers local/regional peculiarities, including possible pollen season overlaps •Pollen season definition captures the MPS
Pollen concentration data	•Pollen concentration data is available •Pollen concentration data is complete or sufficiently available •Pollen concentration data is of good quality •Pollen concentration data is frequently delivered throughout the season, at least enough for the needs of the clinical trial •Pollen concentration data is real measured data of Hirst-type volumetric pollen and spore traps evaluated following minimum recommendations (no forecast data and no other data types previously not validated) •Pollen data is available and applicable (as described above) for a replacement station if needed
Pollen forecast data	•Short-term pollen forecasts are available and of good quality •Mid-term pollen forecasts are available and of good quality •Long-term pollen forecasts are available and of good quality
Risk management	•Disaster plan is existing •Pollen concentration data is available in similar pattern in case of pollen-monitoring station failure for a real and/or virtual biogeographic region
Institutions involved	•Institutions involved in providing aerobiological expertise and data are capable of these tasks •Institutions involved are ISO-certified