According to the timelines of drought1 incidents prepared by the workshop participants, drought occurred at least once in a decade in all the study sites since 1950 (Table 2) but with varied degrees of severity.
However, this consultation and referral process usually happens before marketing authorisation and so is unlikely to be relevant to the timelines examined in this paper.
The LGM protocols specified patient follow-up consultations at three and six months, however due to the timelines of the pilot study, practices were asked to undertake a three month follow-up only.
Whilst any suspected, unexpected, serious adverse reaction (SUSAR) involving insulin therapy will be reported according to the timelines for SUSARs, expected side effects of insulin will be reported in the annual safety report unless serious enough to warrant expedited reporting.
The preparation and distribution of the specific antibodies for SRID assays remains an additional cumbersome step that adds to the timelines for the formulation and clinical evaluation of the influenza vaccine.
