tailieunhanh - Essentials of Clinical Research - part 10

Người ta phải cung cấp một chút chi tiết cho từng phần, chẳng hạn như giải quyết các thiết kế được chọn cho dự án nghiên cứu của bạn và lý do tại sao bạn đã chọn thiết kế chứ không phải là một, dân số bạn sẽ nghiên cứu và lý do tại sao, những gì sẽ được đo và làm thế nào nó sẽ được vận hành trong thiết lập lâm sàng, và những gì lịch trình | 19 Grant Writing 323 One should provide a bit of detail for each section such as addressing the design chosen for your research project and why you chose that design rather than another what population you will study and why what will be measured and how it will be operationalized in the clinical setting and on what schedule. Develop each specific aim as a numerical entity by reiterating it and using BOLDING or a text box in order to highlight it. Briefly re-state the rationale for your each aim. Patient Enrollment Convey to the reviewer your appreciation for the challenges in recruiting. Discuss from where the population will be recruited what the population characteristics gender age inclusion and exclusion criteria will be how subjects will be selected and the specific plans for contact and collaboration with clinicians that may assist you. Provide any previous experience you have with recruitment and include some numbers of subjects and response rates from previous or preliminary studies. Provide strategies to remedy any slow recruitment that might occur. Be cognizant of NIH policies in order to properly address issues related to gender minority and children inclusions and exclusions. One also needs to consider and address the participant burden for the proposed research in order to properly weigh the benefits and costs of participation. In many studies research subjects should be paid but not to the degree that it is coercive. Methods One should provide details for the most important techniques to be used in your research. For commercially available methods you need only to briefly describe or reference the technique but for methods crucial to your aims you need to provide adequate description such as referencing published work abstracts or preliminary studies. In the author s experience there are some common weaknesses of the Methods Section. These weaknesses include such issues as an illogical sequence of study aims and experiments that subsequent aims also