Electronic Clinical Outcome Assessment (ECOA): Can it Improve Clinical Trial Data?

电子临床结局评估(ECOA):能否改善临床试验数据?

2021-03-23 12:00 United Language Group

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Electronic Clinical Outcome Assessment, more commonly known as ECOA, revolves around the procedure of capturing data electronically in clinical trials, as opposed to on paper. Many state that eCOA is built to increase the quality of study data considerably, whilst of course, meeting the regulatory requirements. Coming up, we're going to discuss exactly how it does that, and the benefits it provides along the way. Let's get started. How Does eCOA Improve Data Quality? A wide range of clinical trial stakeholders now consider eCOA as one of the most effective techniques when it comes to capturing high-quality, reliable data. Many sponsors, CROs, and regulators back them in this idea, and have also come to prefer it instead of the traditional, paper-based method. Electronic Clinical Outcome Assessments use electronic reminders, alerts, animated compliance feedback, and dynamic, context-sensitive messaging. It captures data in real-time, delivering an improvement on data quality with reliable information on patient's experiences throughout trials. The Benefits of eCOA in Data Quality ecoa prevents inconsistency and conflictions Since electronic data collection uses logic and branching sequences in order to guide patients through the appropriate questionnaire, patients and site observers are prevented from skipping questions, or entering inconsistent data that conflicts. Ecoa eliminates transcription errors Paper clinical studies usually require site personnel to manually transcribe data into trial management systems, which leaves room for errors and other inconsistencies. By capturing eCOA, the steps become automated. This eliminates transcription errors, along with any inconsistencies, missing data, and other data quality issues that become detected in real-time throughout the electronic data collection. ecoa reaches global regulatory standards The electronic data collection method ensures data is collected and reported according to the global regulatory standards. Unlike the paper method, eCOA data is Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA). As it meets the fundamental elements of quality, regulatory queries are virtually eliminated when it comes to the capture of eCOA data. Regardless of size, CROs and sponsors who continue to rely on error-prone paper diaries to capture vital patient outcomes may be dealing with unnecessary risks to their clinical trials. However, those who turn to eCOA data capturing benefit from regulatory compliance, improved quality in data, and an overall accelerated clinical development. Life Science Language Solutions At United Language Group we pride ourselves in being industry experts, so you don’t need to take the time to bring us up to speed on regulations, industry-specific guidelines, and the strictest global requirements. We understand scientific language and processes as well as the intricacies of settings in which your translations may be used. Let’s connect. hbspt.cta._relativeUrls=true;hbspt.cta.load(3356907, '620117c8-2569-48b8-9f27-0416a4b8c726', {"region":"na1"});
电子临床结果评估(Electronic Clinical Outcome Assessment,简称ECOA)是指在临床试验中以电子方式获取数据的过程,而不是在纸上获取数据。许多人说,eCOA的建立是为了大大提高研究数据的质量,当然,同时满足监管要求。 接下来,我们将详细讨论它是如何做到这一点的,以及它在这一过程中所提供的好处。 我们开始吧。 eCOA如何提高数据质量? 广泛的临床试验利益相关者现在认为eCOA是获取高质量,可靠数据的最有效的技术之一。许多赞助商,CRO和监管者支持他们的这一想法,也开始倾向于采用这种方式,而不是传统的,基于纸张的方式。 电子临床结果评估使用电子提醒,警报,动态依从性反馈和动态的,上下文敏感的消息传递。它实时捕获数据,通过在整个试验过程中提供有关患者经验的可靠信息来提高数据质量。 eCOA在数据质量方面的优势 ecoa防止不一致和冲突 由于电子数据收集使用逻辑和分支序列来引导患者通过适当的问卷,患者和现场观察者可以避免跳过问题或输入不一致的数据,从而产生冲突。 Ecoa消除转录错误 纸质临床研究通常需要现场人员手工将数据转录到试验管理系统中,这就为错误和其他不一致留下了空间。 通过捕获eCOA,这些步骤变得自动化。这消除了转录错误,以及在整个电子数据收集过程中实时检测到的任何不一致,丢失数据和其他数据质量问题。 ecoa达到全球监管标准 电子数据收集方法确保根据全球监管标准收集和报告数据。与纸质方法不同,eCOA数据是可归属的,清晰的,同时期的,原始的和准确的(美国铝业协会)。由于它符合质量的基本要素,当涉及到eCOA数据的捕获时,几乎消除了监管查询。 不管规模大小,继续依赖容易出错的纸质日记来记录重要患者结果的CRO和赞助商可能正在应对其临床试验不必要的风险。然而,那些转向eCOA数据捕获的人受益于法规的遵从性,数据质量的提高,以及总体上加速的临床发展。 生命科学语言解决方案 在联合语言集团,我们为自己是行业专家而自豪,因此您不需要花时间来使我们了解法规,特定行业的指导方针和最严格的全球要求。我们理解科学语言和过程,以及你的翻译可能被使用的复杂环境。我们连线吧。 hbspt.cta._relativeURLS=true;hbspt.cta.load(3356907,'620117C8-2569-48B8-9F27-0416A4B8C726',{“Region”:“NA1”});

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