We will recruit editors, stakeholders and researchers representative of the community of scientists engaged in analysis and publication of time-to-onset analyses in the individual case safety reports (ICSR) database.
We will use an open-text survey to ask the steering and working committees to suggest items that they believe should be included in the guideline under each sub-section of the RECORD-PE guideline.
Panel members will be asked to rank how strongly they believe the proposed theme should be incorporated into the RETAICS-PV reporting guideline.
Items which will be ranked highest in each sub-section will then be considered during regular teleconferences and electronic communication among the working and steering committees. Items will be included in the checklist if more than 80% of participants agreed on the concept, wording, and message of the item.