509 Regulatory Lens of a QA/QC Project Manager

IF 2.1 Q3 MEDICINE, RESEARCH & EXPERIMENTAL
Rachel Bennett, Christine Sego Caldwell
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引用次数: 0

Abstract

OBJECTIVES/GOALS: The primary purpose of the QA/QC Project Manager (PM), appointed under the NCATS UL1 administrative supplement award, is to facilitate quality and timely NCATS prior approval submissions preventing study start delays. Other goals include supporting these projects’ IRB applications and monitoring to ensure data quality and compliance. METHODS/STUDY POPULATION: At the Indiana CTSI, the QA/QC PM is assigned to the Regulatory Knowledge and Support program (RKS) and functions as a unique regulatory service provider. Through monitoring, auditing, and personalized consultations, the IN CTSI QA/QC PM provides study teams with regulatory, GCP, and other compliant study conduct insights while managing NCATS prior approval and RPPR submission quality and timeliness. In contrast to many CTSAs, this role is uniquely situated within RKS and provides QA/QC support through a regulatory lens. The Indiana CTSI QA/QC PM serves on the CTSA QA/QC Lead Team collaborating with NCATS and other CTSA QA/QC personnel. The Lead Team engages with NCATS to host monthly/quarterly meetings and participate in a discussion forum of NCATS and other CTSA QA/QC personnel. RESULTS/ANTICIPATED RESULTS: Not all CTSAs employ the QA/QC PM as regulatory support and the role and skill sets at each CTSA vary, yet the collaborative nature of these individuals across the CTSAs facilitates sharing of resources and knowledge. While prior approval and RPPR submissions vary widely, the QA/QC PMs can rely on their counterparts for guidance complying with the same regulations and policies within unique research settings and institutional nuances. The IN CTSI QA/QC PM, in collaboration with the QA/QC Lead Team, provided quality assurance revisions to the NCATS prior approval instructions which were adopted and published by NCATS January 2022 for implementation at all CTSAs. Ongoing, quality control efforts are accomplished through education, monitoring, and regulatory consultations. DISCUSSION/SIGNIFICANCE: As the research environment evolves, the QA/QC PM responsibilities shift in response to needs within RKS and NCATS. The versatility of the position enables QA/QC to occur at all stages of a study. QA/QC strategies aim to facilitate communication, quality NCATS prior approval and RPPR submissions, and compliance with proposed study conduct.
509 质量保证/质量控制项目经理的监管视角
目标/目的:质量保证/质量控制项目经理(PM)是根据 NCATS UL1 行政补充奖励任命的,其主要目的是促进高质量和及时地提交 NCATS 事先批准,防止研究启动延误。其他目标包括支持这些项目的 IRB 申请和监测,以确保数据质量和合规性。方法/研究对象:在印第安纳中央技术研究所,质量保证/质量控制项目经理被分配到监管知识与支持计划(RKS),并作为一个独特的监管服务提供商发挥作用。通过监控、审核和个性化咨询,印第安纳中试研究所的质量保证/质量控制项目经理为研究团队提供监管、GCP 和其他合规研究行为方面的见解,同时管理 NCATS 事先批准和 RPPR 提交的质量和及时性。与许多 CTSAs 不同的是,该职位在 RKS 中具有独特的地位,通过监管视角提供 QA/QC 支持。印第安纳州 CTSI QA/QC 项目经理是 CTSA QA/QC 领导小组的成员,与 NCATS 和其他 CTSA QA/QC 人员合作。领导小组与 NCATS 合作主办月度/季度会议,并参加 NCATS 和其他 CTSA QA/QC 人员的讨论论坛。结果/预期结果:并非所有 CTSA 都聘用质量保证/质量控制 PM 作为监管支持,每个 CTSA 的角色和技能组合也各不相同,但这些人员在各 CTSA 之间的合作性质促进了资源和知识共享。虽然事先批准和 RPPR 提交工作千差万别,但质量保证/质量控制项目管理人员可以依靠同行的指导,在独特的研究环境和机构细微差别中遵守相同的法规和政策。IN CTSI 的质量保证/质量控制项目经理与质量保证/质量控制领导小组合作,对 NCATS 的事先批准说明进行了质量保证修订,NCATS 于 2022 年 1 月通过并发布了该说明,供所有 CTSA 执行。质量控制工作通过教育、监测和监管咨询持续进行。讨论/意义:随着研究环境的不断变化,质量保证/质量控制项目管理人员的职责也随 着 RKS 和 NCATS 的需求而变化。该职位的多功能性使质量保证/质量控制能够贯穿研究的各个阶段。质量保证/质量控制策略旨在促进沟通、高质量的 NCATS 事先批准和 RPPR 提交,以及遵守拟议的研究行为。
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来源期刊
Journal of Clinical and Translational Science
Journal of Clinical and Translational Science MEDICINE, RESEARCH & EXPERIMENTAL-
CiteScore
2.80
自引率
26.90%
发文量
437
审稿时长
18 weeks
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