T/CGCPU 001-2015 Active Group standards

T/CGCPU 001-2015 Guidelines for Clinical Research Coordinators (CRCs) in the Industry

T/CGCPU 001-2015

Publish Date: 2015-05-20 Implement Date: 2015-05-20 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/CGCPU 001-2015

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Health

ICS Name: Drugs

Publish Date: 2015-05-20

Implement Date: 2015-05-20

Scope

Scope: The "Guide for Clinical Research Coordinators" is divided into nine sections: General Provisions, Normative Reference Documents, Basic Qualifications of CRC Professionals, CRC Professional Training, CRC Professional Competency Assessment, CRC Work Requirements, Penalties, Terminology, and References. Main Technical Content: 1. General Provisions 1.1 Purpose of Guidelines Development 1.2 Content Covered by the Guidelines 1.3 Scope of Application of the Guidelines 1.4 Occupational Definitions and Levels 1.5 Amendment of the Guidelines 2. Normative Reference Documents 3. Basic Requirements for CRC Professionals 3.1 Academic and Professional Requirements 3.2 Professional Ethics Requirements 3.2.1 Basic Professional Ethics 3.2.2 Code of Professional Ethics 3.3 Basic Knowledge and Competencies 3.3.1 Basic Knowledge of Laws and Regulations 3.3.2 Basic Knowledge of Medicine and Nursing 3.3.3 Basic Knowledge of Clinical Drug Trials 3.3.4 Communication and Coordination Abilities 3.3.5 Computer Use and Document Management Abilities 4. Requirements for CRC Professional Training 4.1 Basic Training