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 ...