A new device trial is being considered.

The availability of qualified staff to conduct the trial is essential for maintaining compliance with protocol requirements and ensuring patient safety. Without adequately trained and available staff, the trial’s integrity and data quality are compromised.

This answer is based on GCP guidelines emphasizing the importance of having trained and qualified personnel before initiating a trial.

"The PI must ensure that sufficient qualified staff is available to conduct the trial as per the protocol and regulatory requirements."

Objectives:

Assessing resource availability

Ensuring readiness to initiate a clinical trial