With all sorts of patient-enabling technologies and apps, certainly a single source of data for the clinical trial patient is one of the low hanging fruits to increase patient confidence in our technology and processes.
Academic medical and research centers that are typically strapped for funding and research grants now understand the commercial value of running a well-managed clinical trials center. There has been a great deal of recent investments in technology, compliance, people and processes. The value proposition of integration for these clinical sites is possibly greater than the value to the sponsor based on potential time and cost savings, quality improvements, risk reduction and the recognition that comes along with technology leadership.
Patient privacy is foremost in each of these activities , and the data must be anonymized prior to leaving the EHR premises. But the value proposition is too great. Please let us know what strides your organization has made in this area.
Ken Light has spent nearly thirty years delivering technology implementation, integration, process improvement, and business strategy services to the global Life Sciences community, focused on technology to support clinical research.
Ken has worked with the majority of top twenty pharmaceutical manufacturers, along with many academic, research, and life sciences organizations. Ken is a subject matter expert and frequent presenter at industry conferences related to clinical trial technologies, standards, and strategy. Light has an M. In addition, outlining data management procedures in a data management plan prior to study initiation provides a structured approach that protects data integrity and a documented source for reference throughout the course of the study.
It is also important during the study-planning phase to consider the design of an EDC system and its use throughout the course of the study. For example, the EDC system should incorporate security measures to limit access to authorized personnel only. The system should also utilize an audit trail to document changes to data. When these changes occur, the system should record the date, time, and person responsible for the change. Furthermore, the original data should be preserved to allow an auditor to view what was changed.
Once a study is underway, a continued effort is necessary to ensure study staff is using the EDC system appropriately. Thorough study monitoring by the sponsor is essential in ensuring the accuracy and completeness of data entered into the eCRFs. Furthermore, clinical sites should implement their own quality control measures to help mitigate errors. Study sponsors should provide ongoing training for study staff on the use of EDC systems to address evolving situations such as staff turnover or system updates that change the procedures for use.
Finally, throughout the course of the study, sponsors should ensure an open line of communication between themselves and the study sites to quickly identify and correct difficulties in using the EDC system.
EDC allows for greater efficiency and accuracy in running clinical studies when compared to traditional paper-based methods and therefore, firms are increasingly adopting these systems. However, EDC introduces unique challenges that did not exist with the paper-based methods. This article outlined some electronic data issues based on real-world cases and outlined the best practices that, if appropriately implemented, could help prevent them.
A simple oversight with an EDC system can cause significant problems over the course of a clinical study. Therefore, it is essential to thoroughly plan and monitor the use of EDC systems. By paying the necessary attention to electronic data issues such as these, clinical study professionals can help to ensure a productive and safe clinical study.
FDA recognizes the importance of providing transparency to clinical study professionals related to EDC issues. In order to bring clarity to EDC regulatory expectations, FDA continues to work diligently with industry to update guidance documents. Stay tuned for the release of updated guidance documents. Center for Medicare and Medicaid Services. EHR incentive programs. Food and Drug Administration. Henry J. Kaiser Family Foundation.
Health Information technology. International Organization for Standardization. ISO — Clinical investigation of medical devices for human subjects — Good clinical practice. Integrity has become one of the main issues with everything being digitalized now. But then, if done correctly, data through digitalization can be made more secure than the data from paper-based work. Depends on how much effort people decide to put in. Great article. Love the scenarios.
Great work! Your email address will not be published. Eliminate unnecessary duplication of data entry and eliminate transcription errors.
Enable remote monitoring of data, as the source is readily visible in the mapped data. Promote real-time access for data review, which reduces the time for analysis and provides early responsiveness to protocol concerns.
Facilitate the collection of more accurate and complete data. How is the use of eSource reshaping the future of clinical trials? Using eSource mapped to the EDC system enables a reduction in study start-up, as no additional training on the EDC system will be required. Source data will be maintained in the EMR, thus archiving of paper documents used in the study will no longer be required.
The amount of time it takes to obtain and review data from a study will be reduced, as data will flow in near real time from the EMR to the data tables available for view in the EDC only. Expanding trial access to the point of care enables faster enrollment for more efficient trials. Real-world evidence from direct patient care situations are not influenced by clinical trials. Cross Promo Article S.
Related content. Articles and blogs Blog: Benefits of research as a care option Left Arrow icon.
0コメント