During a mid-study sponsor audit of a clinical trial, the auditor notices that all of...

Subject drug dosing diaries are essential for documenting adherence to the investigational product (IP) regimen. Incomplete or missing diaries compromise the ability to verify whether subjects followed the dosing schedule, which directly affects the trial's data integrity and the reliability of efficacy and safety assessments.

GCP guidelines stress the importance of maintaining accurate and complete dosing records to verify subject compliance with the protocol.

"Accurate documentation of dosing is essential to verify compliance with the investigational product regimen and ensure data accuracy."

Objectives:

Maintain accurate IP administration records.

Ensure compliance monitoring throughout the study.