T/CRHA 057-2024 Active

Scope: This document specifies the requirements for data collection, data governance, data storage, and external services based on the precision medicine database of chronic skin diseases in the Chinese population. This document is applicable to medical institutions and third-party laboratories conducting database construction for clinical research, scientific research, and routine testing of chronic skin diseases. The chronic skin diseases referred to in this document include: psoriasis, vitiligo, atopic dermatitis, systemic lupus erythematosus, autoimmune bullous diseases, bullous skin diseases, acne, chronic urticaria, scleroderma, suppurative hidradenitis, androgenetic alopecia, keloid, and non-melanoma skin tumors (actinic keratosis, squamous cell carcinoma of the skin, basal cell carcinoma). Main technical content: The overall structure of this document is as follows: 1. Scope; 2. Normative reference documents; 3. Terms and definitions; 4. Abbreviations; 5. Scientific research and clinical data standards; 6. Scientific research and clinical data governance requirements; 7. Scientific research and clinical data storage management; 8. Scientific research and clinical data center service requirements; 9. Service security requirements. This document specifies the requirements for data collection, data governance, data storage, and external services based on the precision medicine database of chronic skin diseases in the Chinese population. This document is applicable to medical institutions and third-party laboratories conducting database construction for clinical research, scientific research, and routine testing of chronic skin diseases. The chronic skin diseases referred to in this document include: psoriasis, vitiligo, atopic dermatitis, systemic lupus erythematosus, autoimmune bullous diseases, bullous skin diseases, acne, chronic urticaria, scleroderma, suppurative hidradenitis, androgenetic alopecia, keloid, and non-melanoma skin t