Bioequivalence and Bioavailability Forum

Hi Ken,

❝ 1. When is exactly the study initiation date in BE study ? Is it the date when the first subject signs the informed consent form ?

As far as I know there is no formal definition (for example, terms like enrollment and initiation may or may not mean the same), and I think the answer depends on who you are.
The way ICH E6 is written the trial is initiated after the ethical approval and after the monitor's pre-study visit. Some would say the initiation is when the patient checks in (argument: This is the time then PI assumes responsibility for the medical care of the subject), others -insurers in particular - will try to claim that a trial is not initiated until the patient is dosed with an IMP or subject to an invasive procedure.
Furthermore WHO distinguishes between initiating a trial and conducting a trial.
See also WHO's handbook on GCP, notably the answer to the question "When should informed consent be obtained? What is meant by “prior to trial participation”?"

❝ 2. Is it a must to provide bed to subject ? Can do without bed ? Instead of mattress on the bed, mattress is on the floor for subject to rest.

A bed is not a uniquely defined term. A bed in many languages can be anywhere you sleep or anywhere you can lie down and a mattress is often well within the definition of a bed, so I've been told. I don't speak 100 languages myself so this is second-hand recycled info. The choice of a mattress on the floor vs. a "mattress on a frame with legs" may be influenced by considerations over factors such as hygiene/comfort/risks cf. GCP clauses 2.2 and 2.3, as well as local habits and facility setup. If there's an alarm button 120 cm above the floor and Jane Doe sleeps on a mattress directly on the floor then she may not be able to call for help when she wakes up dizzy and confused in the middle of the night.