The investigator (specifically, the Principal Investigator) is ultimately responsible for product accountability at the study site.

Core responsibility

In clinical trials, guidelines such as ICH GCP state that responsibility for investigational product accountability at the trial site rests with the investigator/institution , even if day‑to‑day tasks are delegated. This means the Principal Investigator must ensure correct receipt, storage, dispensing, return, and documentation of the study product at the site.

Role of other staff

  • Pharmacists and clinical research coordinators can manage many practical aspects (e.g., dispensing, inventory logs), but they do so under the supervision and authority of the investigator.
  • The sponsor must ensure that investigators are qualified and that monitoring is in place, yet this does not remove the investigator’s ultimate accountability for product control at the site.

Information gathered from public forums or data available on the internet and portrayed here.