T/CGCPU 002-2016 Active Group standards

T/CGCPU 002-2016 The on-site evaluation criteria for centralized management of clinical research drugs

Publish Date: 2016-01-15 Implement Date: 2016-01-15 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Price: $ 20.00

Out of stock

Basic Information

Standard Code: T/CGCPU 002-2016

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Health

ICS Name: Drugs

Publish Date: 2016-01-15

Implement Date: 2016-01-15

Scope

Scope: This inspection standard applies to the on-site evaluation of the centralized management of clinical research drugs in drug clinical trial institutions. The on-site evaluation should be conducted at least 2 months after the official operation of the institution's centralized management work. The inspection standards for the centralized management of clinical research drugs include 8 inspection links and 63 inspection items, of which 54 are key items and 9 are general items (marked with ). Key items are those that must meet the standards, while general items are those that are encouraged to meet the standards. The on-site inspection results will be determined based on the compliance rate of the key items. Main technical content: Inspection and evaluation conditions, scoring standards, and result evaluation; on-site inspection content and evaluation standards for the centralized management of clinical research drugs: 1. Space conditions 2. Hardware equipment and facilities 3. Personnel requirements and qualifications 4. Management systems and standard operating procedures 5. Management process and general requirements for clinical research drugs 6. Drug record and file management 7. Management of special drugs 8. Management information system for satellite pharmacies of clinical research drugs