After enrolling and treating a few subjects on an investigator-initiated trial, the PI would like...

Any new data collection tool introduced during a clinical trial, including subject diaries, must be reviewed and approved by the IRB/IEC before implementation. This ensures that the new tool is ethically appropriate, respects subject privacy, and aligns with the approved protocol.

This answer aligns with ICH E6(R2) GCP guidelines, which mandate IRB/IEC approval for any new or modified subject-related documents introduced during a trial.

"All changes in study documents, including subject diaries, must be submitted for IRB/IEC review to ensure compliance with ethical standards."

Objectives:

Maintain compliance with IRB/IEC requirements.

Ensure ethical handling of subject data.