Collaborative Initiative on Fetal Alcohol Spectrum Disorders (CIFASD) Data Coordination Resource

摘要 据报道，全世界近10%的孕妇有产前酒精暴露（PAE）（波波娃， Lange，Probst，Gmel，&雷姆，2017）。在美国，胎儿酒精谱的保守估计 一年级儿童的FASD为1-5%（May等人，2018年）。预计这些数字还会增加， 考虑到孕妇饮酒量的轻微但稳定的上升（Denny，Acero，Terplan和Kim，2020）。 NIAAA建立了胎儿酒精谱系障碍合作倡议（CIFASD）， 通过高度综合的多学科研究，为FASD制定有效的干预措施和治疗方法。 包括基础科学家和临床研究人员的研究计划。CIFASD成功的核心是强大 通过行政资源和数据协调资源（DCR）提供中央协调。 作为CIFASD 5的一部分，DCR将与联盟内的所有项目和资源合作，提供 在数据收集、存储和共享方面提供支持和管理。基于这一核心作用， DCR将协调开展人类受试者研究的CIFASD 5研究者的工作，以满足 将数据存入NIAAA数据档案（NDA）的要求，并将作为主要联系人， NDA在每两年向NDA传输数据的过程中。DCR将负责确保数据共享， CIFASD 5符合NIH政策。此外，发展和改革部将支持行政资源部的工作， 跟踪CIFASD 5的进展。为了实现这些目标，发展和改革委员会提出了以下具体目标： 1.为CIFASD 5创建数据协调资源（DCR）数据库。 2.作为NIAAA数据档案的CIFASD 5联系点。 3.扩展DCR数据库的功能。 4.支持分发存档的CIFASD数据。 5.维护可用于招募的知情同意CIFASD研究参与者的在线登记 到其他项目。

ABSTRACT Almost 10% of pregnancies world-wide were reported to have prenatal alcohol exposure (PAE) (Popova, Lange, Probst, Gmel, & Rehm, 2017). In the United States a conservative estimate of Fetal Alcohol Spectrum Disorders (FASD) in first-grade children was 1-5% (May et al., 2018). These numbers are expected to increase, given the slight but steady rise in alcohol use among pregnant women (Denny, Acero, Terplan, & Kim, 2020). NIAAA established the Collaborative Initiative on the Fetal Alcohol Spectrum Disorders (CIFASD) to inform and develop effective interventions and treatment approaches for FASD through a highly integrated, multidisciplinary research program involving basic scientists and clinical investigators. Central to the success of CIFASD is strong central coordination provided through the Administrative Resource and a Data Coordination Resource (DCR). As part of CIFASD5, the DCR will collaborate with all projects and resources within the consortium to provide support and management with respect to data collection, storage and sharing. Based on this central role, the DCR will coordinate the efforts of the CIFASD5 investigators conducting human subjects research to meet the requirement of depositing data into the NIAAA Data Archive (NDA) and will serve as the primary contact with NDA in the biannual transfer of data to the NDA. The DCR will be responsible for ensuring data sharing in CIFASD5 conforms with NIH Policy. In addition, the DCR will support the efforts of the Administrative Resource in tracking progress of CIFASD5. To meet these goals, the DCR proposes the following specific aims: 1. Create a Data Coordination Resource (DCR) database for CIFASD5. 2. Serve as the CIFASD5 point of contact for the NIAAA Data Archive. 3. Expand the functionality of the DCR database. 4. Support the distribution of archived CIFASD data. 5. Maintain an online registry of consented CIFASD research participants available for recruitment into other projects.