In an effort to minimize protocol noncompliance in neurological research studies that can potentially compromise patient safety, delay completion of the study, and result in premature termination and added costs, we determined the effect of investigator trainings and site initiation visits (SIVs) on the occurrence of noncompliance events. Results of protocol audits conducted at the National Institute of Neurological Disorders and Stroke from 2003 to 2019 on 97 research protocols were retrospectively analyzed. Based on the depth of auditing and provision of investigator research training, audit data were separated into four arms: 1) Early Period, 2003 to 2012; 2) Middle Period, 2013 to 2016; and Late Period, 2017 to 2019, further divided into 3) Late Period without SIVs; and 4) Late Period with SIVs. Events of noncompliance were classified by the type of protocol deviation, the category, and the cause. In total, 952 events occurred across 1080 participants. Protocols audited during the Middle Period, compared to the Early Period, showed a decrease in the percentage of protocols with at least 1 noncompliance event. Protocols with SIVs had a further decrease in major, minor, procedural, eligibility, and policy events. Additionally, protocols audited during the Early Period had on average 0.46 major deviations per participant, compared to 0.26 events in protocols audited during the Middle Period, and 0.08 events in protocols audited during the Late Period with SIVs. Protocol deviations and noncompliance events in neurological clinical trials can be reduced by targeted investigator trainings and SIVs. These measures have major impacts on the integrity, safety, and effectiveness of human subjects research in neurology.

为了最大限度地减少神经学研究中可能危及患者安全、延迟研究完成并导致提前终止和增加成本的方案不合规情况，我们确定了研究者培训和现场初始访视 (SIV) 对事件发生的影响的不合规事件。回顾性分析了国家神经疾病和中风研究所 2003 年至 2019 年对 97 个研究方案进行的方案审核结果。根据审计的深度和研究者研究培训的提供情况，审计数据分为四个部分：1）早期，2003 年至 2012 年； 2）中期，2013年至2016年；后期，2017年至2019年，进一步分为3）没有SIV的后期； 4) 后期 SIV。不合规事件按照协议偏差的类型、类别和原因进行分类。总共有 1080 名参与者发生了 952 起事件。与早期相比，中期审核的协议显示，至少发生 1 次不合规事件的协议百分比有所下降。具有重大意义投资工具的协议在主要、次要、程序、资格和政策事件方面进一步减少。此外，早期审计的协议中每个参与者平均有 0.46 个重大偏差，而中期审计的协议中有 0.26 个事件，而后期审计的协议中有 0.08 个重大偏差事件。通过有针对性的研究者培训和 SIV 可以减少神经临床试验中的方案偏差和不合规事件。这些措施对神经病学人体研究的完整性、安全性和有效性产生重大影响。