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赞助项目管理

A Coverage Analysis is a systematic review of all procedures detailed in the study protocol to determine:

  • Is a service or procedure required billable?
  • Where will this service or procedure occur?
  • Is this service a standard of care which can be paid for by the patient/patient insurance, or a research charge that will be paid for by the sponsor?

PROCESS

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。

在确定了计费风险之后,CRFA团队随后在覆盖范围分析和预算工具中建立了事件时间表。CRFA团队将确定在此期间进行的每个活动。然后,CRFA团队将通过电子邮件将覆盖范围分析的骨架通过电子邮件发送给部门管理员,该部门将与主要调查员合作,以确定将要执行每个程序的位置,以及该程序是否是该访问的护理或研究标准。beplay苹果手机能用吗对于所有被确定为护理标准的项目,该部门必须提供一个辩护,以引用国家准则或同行审查的出版物,这表明该活动在治疗患者病情方面是足够的和必要的。

Once this information has been completed by the department, they will submit the Coverage Analysis along with the signed answers to the Qualifying Questions and Billing Certification Form to the CRFA team for final review and approval. If the CRFA team has any questions or comments, they will work with the department to get to a final Coverage Analysis that is acceptable to both parties. CRFA team will then send the final Coverage Analysis to the Committee for Protection of Human Subjects for upload into iRIS, create the necessary EG billing accounts in GE Centricity, and notify Memorial Hermann of the completed Coverage Analysis (when necessary).

护理标准与beplay苹果手机能用吗研究成本

就UTHealth的覆盖范围分析而言,护理活动的标准是患者无论参与研究,而研究成本是在此工作之外进行的。beplay苹果手机能用吗考虑差异的另一种方法是,您的正常诊所实践是否正在改变以适应服务或程序。此外,在知情同意书中免费承诺的任何活动都会自动成为研究成本。beplay苹果手机能用吗

有用的护理标准网站与研究:beplay苹果手机能用吗

https://www.cms.gov/medicare/coverage/clinicaltrialpolicies

https://www.fda.gov/ForPatients/ClinicalTrials/ClinicalvsMedical/default.htm

DEPARTMENT TASKS/RESPONSIBILITIES

  • 如果不需要覆盖分析,提供足够的信息
  • 输入服务,成本,精力和概述潜在付款人的位置到覆盖范围分析模板中
  • 向CRFA提交完整的承保分析
  • Review any changes made to the Coverage Analysis document
  • Provide the NCT number, Qualifying Questions page, and PI Billing Cert page
  • 使用最终覆盖范围分析来验证所有定价并协商赞助商预算
  • Maintain all records

SPA TASKS/RESPONSIBILITIES

  • 审查IRB申请潜在计费风险
  • 为研究团队构建覆盖分析模板
  • 通知潜在计费风险并提供覆盖范围分析模板
  • Analyze completed Coverage Analysis after department has entered locations of services, costs, effort, and outline potential payers
  • 将最终覆盖范围分析路由到CPHS,MHH和部门
  • Create EG accounts and upload NCT number into GE
  • Maintain all records
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