T/CRHA 067-2024 Active

Scope: This document specifies the management requirements, follow-up work, and quality control requirements in telephone follow-up of clinical research, including the inclusion of research subjects, follow-up, handling of refusals and dropouts, and maintaining the compliance of research subjects; Main technical content: The overall structure adopted by this document is as follows: 1. Scope; 2. Normative reference documents; 3. Terms and definitions; 4. Management requirements; 5. Follow-up work; 6. Quality control. This document is applicable to telephone follow-up work of various prospective clinical research (such as drug clinical trials, registration studies of research subjects, and special disease cohort studies) initiated and conducted by doctors, nurses, and researchers in medical institutions at all levels. Other clinical-related telephone follow-up work can refer to and use this document for reference.