Screen

1
Definition e.g Heart Rate, systolic/diastolic bp
etc, what it is and relationship to e.g.
pulse. Definition (planned) Context how
measured (e.g. type of instrument) and
qualifiers (e.g sitting, standing, supine, angle,
units etc) Definition Actual context for an
individual (actually standing even though
supposed to be sitting, Never seen this but
conceivable (e.g. lab samples, hemolysed/broken
samples, thawed/ -80 instead of -20 etc) Trial
(planned) context Screening vs baseline vs
final, vs safety baseline vs efficacy baseline,
vs arm of the trial. Position relative to
planned active treatment, planned tests (e.g.
element/visit of the trial). Patient (actual)
context relative to actual active treatments,
medical history, adverse events, concomitant
medications, genotype etc. Last observation
carried forward, Intent to treat, evaluable.
Days from planned.
S screening HR A baseline HR for safety A C
efficacy HR baselines B D efficacy final HR
Heart Rate C
Heart Rate A
Heart Rate S
Screen
Treat A
Final
Treat B
Wash Out
Run In
Arm AB
Heart Rate x
Heart Rate D
Heart Rate x