T/SHSPS 001-2024
Standards for Management and Competency Assessment of Clinical Trial Coordinators (Shanghai) (English Version)

Standard No.
T/SHSPS 001-2024
Language
Chinese, Available in English version
Release Date
2024
Published By
Group Standards of the People's Republic of China  CN  /  TUANTI
Latest
T/SHSPS 001-2024
 
Scope
1. Scope; 2. Normative reference documents; 3. Terms and definitions; 4. Abbreviations; 5. Relevant requirements of CRC; 6. Scope of responsibilities of CRC; 7. Relevant requirements of SMO companies; 8. Clinical trial institutions /Researcher related requirements; 9. Negative list

T/SHSPS 001-2024 history

  • 2024 T/SHSPS 001-2024 Standards for Management and Competency Assessment of Clinical Trial Coordinators (Shanghai)

Topics on standards and specifications

Clinical trial pre-test evaluation Clinical Performance Evaluation Non-clinical clinical trial management standards Clinical trial listing

Standard and Specification

GOST R ISO 14155-1-2008 Clinical investigation of medical devices for human subjects. Part 1. General requirements UNI 11585:2015 Non-regulated professions - Professionals operating in the field of monitoring of clinical trials of medicinal products (Clinical Monitor) - Knowledge, skill DIN EN ISO 14155-1 E:2001-08 Clinical Investigation of Medical Devices Suitable for Humans Part 1: General Requirements (Draft DIN EN ISO 11979-7 E:2012-07 Ophthalmic Implants Intraocular Lenses Part 7: Clinical Studies of Intraocular Lenses for the Correction of Aphakia (Draft DB31/ 928-2015 Norm of energy consumption per unit product of vacuum heat treated metals WFAS 008.1-2023 Acupuncture Case Registration Implementation Guide DB31/ 927-2015 The norm of energy consumption per unit product of heat treatment in controlled atmosphere procedure of ferrous metals DIN EN ISO 11979-7 E:2023-04 Ophthalmic Implants Intraocular Lenses Part 7: Clinical Studies of Intraocular Lenses for the Correction of Aphakia (Draft EN ISO 14731:2019 Welding coordination - Tasks and responsibilities (ISO 14731:2019 ISO 14731:2019 Welding coordination — Tasks and responsibilities


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