T/XSMIA 0005-2022 Digitalization of integrated cell resource bank application technology guidance
T/XSMIA 0005-2022 Digitalization of integrated cell resource bank application technology guidance
Basic Information
Scope
Scope: This document provides basic guidelines for the digital construction of comprehensive cell resource banks. This document outlines the technical guidelines for the digital construction of comprehensive cell resource banks in terms of business applications, management applications, digital foundation technologies, and security assurance technologies, covering raw material collection, preparation, storage, quality inspection, warehousing, clinical trial research, bioinformatics management, data management, and security assurance management. This document is applicable to the digital construction of comprehensive cell resource banks. Main technical content: I. Business Applications (I) Collection Management: Basic Information, Evaluation and Screening, Institutional Qualifications, Collection Plan, Collection Methods, Material Handover (II) Preparation Management: Reagents and Supplies, Raw Material Reception, Raw Material Management, Preparation Plan, Separation and Preparation, Submission for Inspection Management (III) Quality Inspection Management: Quality Inspection Plan, Sample Handover, Quality Inspection Operations, External Testing, Quality Inspection Information, Report Management (IV) Storage Management: Warehousing Management, Cryopreservation Management, Thawing Management, Storage Management, Outbound Management, Destruction Management (V) Scientific Research Project Management: Project Registration, Project Review, Project Application, Data Management and Analysis, Project Performance, Project Outcomes (VI) Clinical Trial Research: Registration and Review, Project Approval, Design Evaluation, Fund Management, Change Management, Supervision and Guidance, Conclusion Report, Archive Management (VII) External Training Project Management: Live Streaming Courses, Recorded Courses, Examination System, Conference Management, Hands-on Management, Back-end Management, Data Statistics, Personal Center (VIII) Laboratory Operation Management: Rental Application