Types and main points of site inspections of drug clinical trial institutions in China
XIE Qin
SONG Shu-fen
Abstract：Before and after acquiring the qualifications, all drug clinical trial institutions should be received for various on-site inspections by different levels of supervisory departments. The inspections can be classified as five types as follows: the inspection of qualification-verification, the ordinary inspections, the qualification-review inspections, the inspection with special causes and the on-site inspection for drug registrations. When the institutions get the qualification to conduct the drug clinical trial, they should receive the late four type inspections. This article summarized the four types of on-site inspections. Even though all the inspections have the same contents, each type of the four inspections has its own main points for the different purposes. This article also explained the main points of the inspections corresponding to the different types in the process of drug clinical trials.
Keywords：drug clinical trialon-site inspectionstypesmain points
Publication Date：2009-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：4( 2020-2023 )