Massachusetts General Hospital Diabetes Center, Harvard Medical School, Boston, MA 02114, USA.
Clin Trials. 2012 Aug;9(4):418-25. doi: 10.1177/1740774512449532. Epub 2012 Jun 22.
The role of the study coordinator (SC) in multicenter studies of long duration has received limited attention.
To describe the evolution of the SC's role during the 28-year Diabetes Control and Complications Trial (DCCT) and its follow-up study, the Epidemiology of Diabetes Interventions and Complications (EDIC) study.
The evolution of the SC's position from the traditional role of protocol implementation to that of research collaborator and co-investigator, based on personal experience and observation, is described in detail. Findings from a survey regarding professional demographics and job satisfaction, completed by all 28 SCs in 2010, provided additional information. We used dimensions of the SC's role specific to DCCT/EDIC to construct a classification schema of functions and responsibilities that describe the SC's role.
Among the 28 SCs, 24 were nurses, 12 held bachelor's degrees, 11 had a master's degree, 19 were certified diabetes educators (CDEs), 12 had worked with DCCT/EDIC for more than 20 years, and 5 had been with the study since its inception (>26 years). Responses confirmed a high degree of functional consistency across sites with data acquisition, performing study procedures, recruitment and consent for additional ancillary studies, regulatory management, scheduling, clinical consultation, and ongoing contact with study participants frequently reported. Study-wide leadership activities, a category not generally included in the usual SC role, were reported by approximately 30% of the SCs. The level of professional satisfaction was high with two-thirds being very satisfied, one-third moderately to quite satisfied, and none dissatisfied.
The limitations include a relatively small sample size, self-reported data, and a single long-term multicenter trial and observational follow-up study on which we based our findings and conclusions.
By optimizing their organizational and scientific contributions to the overall research endeavor, SCs in DCCT/EDIC have made major contributions to the unprecedented success of the study and report high job satisfaction. The efforts of the SCs have been integral to the remarkably high participant retention and data completion rates. The DCCT/EDIC experience may serve as a model for the role of the SC in future diabetes and other multicenter clinical trials.
研究协调员（SC）在长期多中心研究中的作用受到的关注有限。
描述 28 年糖尿病控制与并发症试验（DCCT）及其后续研究——糖尿病干预和并发症的流行病学（EDIC）研究中 SC 角色的演变。
基于个人经验和观察，详细描述了 SC 从传统的方案实施角色演变为研究合作者和共同研究者的过程。2010 年，所有 28 名 SC 完成的一项关于专业人口统计学和工作满意度的调查提供了更多信息。我们使用 DCCT/EDIC 中 SC 角色的特定维度构建了一个功能和职责分类方案，描述了 SC 的角色。
在 28 名 SC 中，24 名为护士，12 名拥有学士学位，11 名拥有硕士学位，19 名是认证糖尿病教育者（CDE），12 名在 DCCT/EDIC 工作超过 20 年，5 名从研究开始就一直在参与（>26 年）。研究结果证实，站点之间的数据采集、执行研究程序、招募和同意额外的辅助研究、监管管理、日程安排、临床咨询以及与研究参与者的持续联系具有高度的功能一致性，这是经常报告的。大约 30%的 SC 报告了研究范围内的领导活动，这一类别通常不包括在 SC 的常规角色中。超过三分之二的人非常满意，三分之一的人比较满意，没有人不满意。
本研究存在一定的局限性，包括样本量相对较小、自我报告的数据以及我们所依据的发现和结论的单一长期多中心试验和观察性随访研究。
通过优化他们对整体研究工作的组织和科学贡献，DCCT/EDIC 的 SC 为研究的空前成功做出了重大贡献，并报告了很高的工作满意度。SC 的努力是参与者保留率和数据完成率显著提高的关键因素。DCCT/EDIC 的经验可以作为 SC 在未来糖尿病和其他多中心临床试验中作用的模型。
