The Environmental Polymorphisms Registry - Operational

该战略计划的目的是继续开展环境多态性登记册的活动。 EPR在整个北卡罗来纳州招募了15,000多名积极参与者，他们每人都为DNA分离和基因分型捐献了血液。 此外，近9，000名参与者通过健康和接触问卷获得了表型数据。 EPR SP最初设计为“表型-基因型”队列，一旦确定了具有感兴趣基因型的受试者，研究者可以申请重新鉴定标本，并要求相同的受试者参加后续表型研究。 然而，最近研究者也可以根据暴露或关注的疾病状态选择参与者参与随访研究。 业务活动包括招募受试者，每年一次重新联系和追踪所有EPR受试者，支持EPR数据库的开发和维护，进行数据分析和数据挖掘以支持EPR活动和手稿的编写，将先前的书面数据输入数据库，并支持EPR基因分型和EPR表型研究。 尤其重要的是保持IRB的合规性。 与IRB互动，获得IRB对方案和生物标本采集的批准。 这包括制定和修订IRB批准所需的研究方案和其他相关文件（ICF、受试者介绍信、脚本等）。 可能要求承包商根据IRB的建议修订研究文件，并协助进行修订、更新、方案违背和偏离以及其他IRB提交。

The purpose of this SP is to continue activities for the Environmental Polymorphism Registry (EPR). The EPR has over 15,000 active participants recruited throughout North Carolina who have each donated blood for DNA isolation and genotyping. In addition, close to 9,000 participants have phenotypic data available through a health and exposure questionnaire. Originally the EPR SPs designed to be a “phenotype by genotype” cohort where once participants with genotypes of interest have been identified, investigators can apply for re-identification of the specimens and ask the same participants to participate in follow-up phenotyping studies. However, recently Investigators may also select participants to participate in follow-up studies based upon exposure or disease states of interest. Operational activities include recruiting subjects, recontacting and tracing all EPR subjects once a year, support development and maintenance of the EPR database, conducting data analyses and data mining to support EPR activities and the preparation of manuscripts, entering prior written data into the database, and supporting EPR genotyping and EPR phenotyping studies. Especially important is maintaining IRB compliance. Interacting with the IRB, obtaining IRB approval for protocols, and biospecimen collection. This includes developing and amending the study protocol and other associated documents (ICF, subject introduction letter, scripts, etc) that are required for IRB approval. Contractor may be required to revise study documents based on the recommendations of IRB, and aid with amendments, renewals, protocol violations and deviations and other IRB submissions.