These data suggest that improving physician and laboratory reporting practices and logistics could shorten the reporting timeline by 1 or 2 days for most cases.
This estimate is comparable to the previously reported timeline (35 to 37.8 MY) for the divergence of the two species [ 35, 36].
Trepka et al. found that increasing relationships between clinicians and public health staff results in an increased percentage of reported cases and improved reporting timelines.
The weight of testimony given to the Observer – witness statements, psychologists' reports, timelines, contemporaneous diary extracts, spoken accounts – is stark and overwhelming.
Any and all adverse events were collected within the electronic database reporting system (C3D) following strict one-week reporting timelines.
Any and all adverse events were collected within an electronic database reporting system (C3D) [32] that followed strict reporting timelines.
All SAE's will be reported to Health Canada as per the required reporting timelines.
The roles, responsibilities and reporting timelines were clearly defined on the surveillance data flow for each level to avoid confusion and to ensure regular submission of data.
A study physician will review all adverse event reports to determine whether they are serious, study related, or expected, and the events will be reported to the IRB, DSMB, and the sponsor according to the reporting timelines appropriate to the type of the event.
While individual causality assessments made by staff during a trial allow for clinical decisions and adherence to regulatory reporting timelines, a central tenet is that evidence for causality is determined for registration purposes on the basis of aggregated data at the end of a trial or on meta-analysis with data from similar trials.
