The sponsor should supply a PI with the IP after:

The sponsor may only provide the investigational product (IP) after the IRB/IEC and relevant regulatory authorities have approved the protocol. This ensures that the trial complies with ethical and legal standards before initiating IP administration.

According to GCP guidelines, sponsors must wait for all necessary approvals before distributing IP to the trial site.

"The investigational product may only be supplied after obtaining regulatory and IRB/IEC approval to ensure ethical conduct of the trial."

Objectives:

Ensure regulatory compliance before initiating IP distribution.

Protect participant safety and ethical standards.