Improving Business Process Performance

Appendix D: Clinical Trial Process Specification  ◾  303

a. e monitor is responsible for overseeing the progress of a clinical

trial and ensuring that it is conducted, recorded, and reported in

accordance with protocol.

b. Verifying that the investigator has adequate qualifications and

resources and these remain adequate throughout the trial period, and

that the staff and facilities, including laboratories and equipment, are

adequate to safely and properly conduct the trial, and these remain

adequate throughout the trial period.

c. Verifying for the investigational product that:

i. Storage times and conditions are acceptable, and that supplies

are sufficient throughout the trial

ii. e investigational products are supplied ...