Core-006

网络能力：CCTSI将建立CTSA试验创新网络枢纽联络团队，以密切 与国家NCATS试验创新中心(TICS)和招聘创新中心协调 (RICS)在试验创新网络(TIN)内。为此次网络扩展奠定了基础， CCTSI已经在许多地方倡议中发挥了关键作用，使该机构能够充分和稳健地 参与TIN(例如，ACTA和SMART IRB签约)。临床研究管理办公室 (CRAO)成立于2016年1月，旨在将行政、合同和 来自安舒茨医学院的临床试验监管组件，对于扩展 我们的网络容量。该办公室与IRB、赠款和合同办公室、研究 合规和支持临床研究所需的其他关键机构，以及CCTSI BERD和信息学核心。中心联络小组将在这一集中研究工作的基础上，促进 从我们中心的罐子里进行的多中心试验。CRAO还将该机构定位为更好地监测 临床试验的开发、启动、实施和结束，并在这些方面提高效率 流程。CCTSI支持的研究监测委员会通过提供 监督正在进行的研究，并将与中心团队合作，保持适当的应计水平 支持TIN多中心试验。此外，我们强大的CCTSI临床研究单位网络(CTRC) 提供进行这些试验所需的设施和人员。中心联络处的设立 团队现在将提供当地资源，以极大地促进NIH资助(和其他)多站点的绩效 通过三个具体目标在我们的机构进行试验：目标1将全面建立和优化TIN中心联络 CCTSI内的团队，开发基础设施和人员，为TIN研究提供持续支持 并在当地开展多点临床试验。目标2：TIN Hub联络小组将制定流程 和程序，以充分便利CCTSI内多中心试验的运作，其中 起源于TIN内的其他位置。目标3：枢纽联络小组将支持开发和 将本地产生的多点临床试验推广到TIN。CRAO提供的基础是 TIN Hub联络小组将在此基础上再接再厉，确保获得协调良好的机构临床研究 行政管理。中心团队将与TIN协调连接并支持当地调查人员 这方面的资源，允许促进多中心临床试验，从而扩大我们的网络 容量。

Network Capacity: The CCTSI will develop a CTSA Trial Innovation Network Hub Liaison Team to closely coordinate with the national NCATS Trial Innovation Centers (TICs) and Recruitment Innovation Centers (RICs) within the Trial Innovation Network (TIN). Providing the foundation for this network expansion, the CCTSI has already played a key role in the many local initiatives to enable the institution’s full and robust involvement in the TIN (e.g., ACTA and SMART IRB sign-ons). The Clinical Research Administration Office (CRAO) was created in January of 2016 to bring together in one location the administrative, contracting and regulatory components for clinical trials from across the Anschutz Medical Campus, essential for expansion of our network capacity. This office is well connected to the IRB, the Office of Grants and Contracts, research compliance and other critical institutional bodies necessary to support clinical research, as well as the CCTSI BERD and Informatics Cores. The Hub Liaison Team will build on this centralized research effort to facilitate multi-center trials from the TIN at our center. CRAO also positions the institution to better monitor progress of clinical trial development, start-up, implementation and close-out and to advance efficiencies into these processes. The CCTSI-supported Study Monitoring Committee complements these efforts by providing oversight over ongoing studies and will work with the Hub Team to maintain appropriate levels of accrual support for TIN multi-center trials. In addition, our robust CCTSI clinical research unit network (CTRCs) provides the facilities and personnel needed to conduct these trials. The establishment of the Hub Liaison Team will now provide a local resource to greatly facilitate the performance of NIH-funded (and other) multi-site trials at our institutions through 3 Specific Aims: Aim 1 will fully establish and optimize the TIN Hub Liaison Team within the CCTSI, developing the infrastructure and personnel to provide ongoing support to TIN studies and local development of multi-site clinical trials. Aim 2: The TIN Hub Liaison Team will develop the processes and procedures to adequately facilitate the operationalizing of multi-center trials within the CCTSI, which originate at other sites within the TIN. Aim 3: The Hub Liaison Team will support the development and advancement of locally-generated multi-site clinical trials to the TIN. The CRAO provides the foundation that the TIN Hub Liaison Team will build upon, ensuring access to a well-coordinated institutional clinical research administration. The Hub Team will connect and support local investigators in coordination with the TIN resources in this context, allowing for the facilitation of multi-center clinical trials, thus expanding our network capacity.