Bioequivalence and Bioavailability Forum

Dear Soma!

❝ This was discussed and few of my friends are considering it as serious

❝ adverse event as a part of study but I fully disagreee with them.

I agree with Simon's post (and your friends). We once had a case where a volunteer in the washout-phase of a BE study was bitten by a dog (don't laugh!). The event was reported and classified as 'unrelated'.
See ICH-E6(R1) (Section 1.2 Adverse Event (AE)):

Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).
(My emphasis in blue.)

According to ICH-E2A (Section II.) a car accident, even when the subject was only a fellow passenger is an Adverse Event, because

Adverse Event [is] any [...] disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

The AE should be rated as 'serious', because the subject

[...] requires inpatient hospitalisation [...].