True or False: ICH E6 states that the investigator should maintain control of essential documents during and after the trial.

The statement is true because ICH E6 provides guidelines regarding the responsibilities of investigators in clinical trials, emphasizing the importance of maintaining control over essential documents. Essential documents include items such as the study protocol, informed consent forms, and any regulatory documents required for the trial.

The guidelines stipulate that investigators must ensure these documents are well-organized, readily available for monitoring, and safeguarded throughout the duration of the trial and beyond. Maintaining control over these documents is critical not only for the integrity of the trial but also for compliance with regulatory requirements and for facilitating audits and inspections by authorities or sponsors.

This responsibility persists even after the trial has concluded because proper management and retention of these documents support ongoing data integrity and ensure that historical records are available for future reference, including post-trial responsibilities.