tailieunhanh - A MANAGER’S GUIDE TO THE DESIGN AND CONDUCT OF CLINICAL TRIALS - PART 8

CRM đặt một cuộc gọi điện thoại để điều phối viên trang web để xác định nguồn gốc của những khó khăn. 2. Cô ấy những gì cô ấy có thể tạo điều kiện thuận lợi cho việc thu thập và truyền tải các thông tin cần thiết. | TABLE CRFs from Examining Physician Oct 10 1999 Site Patient Elig Baseline 2wk 1 mo 2mo 3mo 6mo 1 yr 001 100 6 3 99 6 18 99 7 8 99 7 22 99 8 25 99 9 25 99 001 101 7 8 99 8 01 99 8 15 99 8 31 99 9 30 99 10 30 99 1. The CRM places a telephone call to the site coordinator to determine the source of the difficulty. 2. She does what she can to facilitate collection and transmission of the needed information. 3. If the missing data involve several patients at the same site she may choose to visit the site or to refer the matter to the medical monitor. 4. In turn the medical monitor may either deal with the problem s or refer them to the project manager. 5. The primary responsibility of the project manager is to ensure that procedures are in place and that decisions are made not deferred. DROPOUTS AND WITHDRAWALS Missing or delayed forms are your first indication of problems involving dropouts or withdrawals. The first step is to determine whether the problem can be localized to one or two sites. If the problems are widespread they should be referred to the biostatistician who has access to the treatment code to determine whether the withdrawals are treatment related. Problems that can be localized to a few sites are best dealt with by a visit to that site. Widespread problems should be referred to an internal committee to determine the action to be taken. CLINICAL TRIALS REPRESENT A LONG-TERM COMMITMENT Bumbling lost interest in their Brethren device test midway through when they realized the results just weren t going to come out the way they planned. They probably would have shelved the project indefinitely had not it been brought forcefully to their attention that when you experiment with human subjects the government insists on knowing the results whether or not they favor your product. PROTOCOL VIOLATIONS Suspected protocol violations should be referred to the medical monitor for immediate follow-up action. As discussed in Chapter 7 a variety of corrective .