Who is responsible for submitting a protocol amendment to the IRB/IEC?

The investigator holds the responsibility for submitting any protocol amendments to the IRB/IEC for review and approval. This step ensures that all changes are ethically evaluated before being implemented, maintaining compliance with regulatory requirements.

According to GCP guidelines, the investigator must submit protocol changes to the IRB/IEC to secure approval before making any modifications to the study.

"The investigator must inform the IRB/IEC of any proposed protocol changes and secure approval prior to implementation."

Objectives:

Maintain ethical oversight in study modifications.

Adhere to regulatory submission requirements.