Cate sự cần thiết phải sửa đổi các thủ tục mà không vi phạm một số nhà điều tra. Hãy để màn hình nghiên cứu lâm sàng (CRM) và điều tra viên cùng đổ lỗi cho các phần mềm. Dễ dàng truy cập. Nói chung, cùng một phần mềm đơn giản hóa việc nhập dữ liệu làm cho dễ dàng cho chuyên nghiệp máy tính để truy cập và hiển thị các kết quả. | cate the need for modification of procedures without offending some investigators. Let the clinical research monitor CRM and the investigator jointly blame the software. Ease of access. Generally the same software that simplifies data entry makes it easy for the non-computer professional to access and display the result. We expand on this point in Chapter 11 Both your staff and the regulatory agency will have earlier access to trial data compared with paper CRFs. Many regulatory agencies such as the FDA now accept and even prefer electronic submissions also known as e-subs or CANDAs thus doing away with the need to manage or store paper case report forms. If paper forms are required they are readily produced. And if a paper form turns up missing it is easily regenerated from the electronic record and submitted to the investigator for signature. Security procedures for electronic records are discussed in Chapter 11 also. Implementation of computer-assisted entry involves three steps 1. Developing and testing the data entry software 2. Training medical and paramedical personnel in the software s use 3. Monitoring the quality of the data. We discuss the first two of these steps in the following sections and the last step in Chapters 13 and 14. PRE-DATA SCREEN DEVELOPMENT CHECKLIST All required data have been grouped by the individual who will collect the data patient front-office person nurse physician and the time at which it will be collected initial screen baseline 1-week follow-up . For each data item the units and acceptable range have been specified. See Table . DEVELOP THE DATA ENTRY SOFTWARE The first steps in software development are to Decide which software product to use to develop the data-entry screens A list of commercially available software is provided in the Appendix. TABLE Data Specifications Table Item Group Units Question if Reject unless Year of birth Bp Year 17 Current year - Birth year 81 Diastolic pressure B Fn mmHg DP 50 or DP 110 30
