覆盖范围分析是对研究协议中详述的所有程序的系统综述，以确定：

• 服务或程序是否需要计费？
• 此服务或过程将在哪里发生？
• 这项服务是可以由患者/患者保险支付的护理标准，还是由赞助商支付的研究费用？beplay苹果手机能用吗

过程

为了进行覆盖分析，必须对所有研究文件，诊所程序和国家准则进行全面审查。在Uthealth，这始于临床研究金融与管理（CRFA）团队的计费风险审查。beplay苹果手机能用吗每周，CRFA团队都会审查上一周从机构审查委员会提交的所有协议。在审查协议时，CRFA分析了活动时间表，以确定任何活动是否可以在临床计费系统中产生指控。如果一项研究的活动可以产生账单，则将其指定为计费风险。

风险识别账单后,CRFA团队then builds out the schedule of events in the Coverage Analysis and Budget tool. The CRFA team will identify which visit each activity occurs during this build out. The CRFA team will then email the Coverage Analysis skeleton to the department administrator who will work with the Principal Investigator to determine the location where each procedure will be done and whether that procedure is standard of care or research for that visit. For all items that are determined to be standard of care, the department must provide a justification referencing a national guideline or peer reviewed publication which indicates that the activity is adequate and necessary in the treatment of the patient’s condition.

该部门完成此信息后，他们将向CRFA团队提交覆盖范围分析以及合格问题和计费认证表的签名答案，以进行最终审查和批准。如果CRFA团队有任何疑问或评论，他们将与部门合作，进行双方都可以接受的最终覆盖范围分析。然后，CRFA团队将将最终覆盖范围分析发送给委员会，以保护人类受试者上传到IRIS，创建必要的EG计费帐户，并将纪念赫尔曼通知纪念赫尔曼（在必要时）。

STANDARD OF CARE VS. RESEARCH COST

In the terms of the UTHealth Coverage Analysis, standard of care activities are those which the patient would receive regardless of their participation in the study, while research costs are those that being performed outside of this. Another way to think about the difference, is whether or not your normal clinic practice is changing to accommodate the service or procedure. In addition, any activities which are promised as free of charge in the Informed Consent Form automatically become research costs.

Helpful websites for standard of care vs research:

https://www.cms.gov/Medicare/Coverage/ClinicalTrialPolicies

https://www.fda.gov/forpatients/clinicaltrials/clinicalvsmedical/default.htm

部门任务/责任

• Provide sufficient information if a Coverage Analysis is not needed
• Input locations of services, costs, effort, and outline potential payers into the Coverage Analysis template
• Submit completed Coverage Analysis to CRFA
• 查看对覆盖分析文件的任何更改
• 提供NCT编号，合格问题页面和PI计费证书页面
• Use final Coverage Analysis to verify all pricing and negotiate sponsor budgets
• 维护所有记录

水疗任务/职责

• Review IRB application for potential billing risk
• 为研究团队构建覆盖分析模板
• Notify department of potential billing risk and provide Coverage Analysis template
• 分析部门进入服务，成本，努力和概述潜在付款人的位置后，分析完成的覆盖范围分析
• Route the final Coverage Analysis to CPHS, MHH, and the department
• 创建EG帐户并将NCT编号上传到GE
• 维护所有记录