Bioequivalence and Bioavailability Forum

Dear All,

As per Good Clinical Practise whether the following case would be serious adverse event or not?
A person involved in clinical study (Phase II) met with an accident and have injury and was admitted to hospital, but neither he was driving the car nor he was walking on the road. He was in the car but the car was driven by another person who is not involved in the study.

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.

Kindly, let me know.

Thanking you,

Regards,

Soma Pillai

---

Edit: Category and subject line changed. [Helmut]