![]() Phase 3 and Phase 4 clinical trials, pharmaco-vigilance studies, and safety surveillance activities are some other examples where EDC systems are used. Although they primarily complement data collection activities in clinical research studies, they are also used by clinicians for populating registries and databases. The definition of EDC systems also extends to interactive voice response systems (IVR) where a subject can report information through a phone, electronic diaries that capture subject reported outcomes and point of contact data collection systems that use devices such as digital pen and tablet computers to capture data. In other cases electronic data entry is subsequent to a paper based CRF data entry. In most cases information collected from the subject is directly fed into an electronic CRF (eCRF) through a browser. Although the use of electronic media to capture data into an online database is a basic defining feature, there exists a diverse variation in EDC systems based on the technology used and the intended target audience. With the advent of information technology in health care, EDC systems have emerged as an alternative to paper-based systems.ĮDC systems are computerized systems designed to collect and manage clinical and laboratory data in an electronic format. Further, scanning paper questionnaires to populate a database is time-consuming and affected by data recognition errors. Despite being simple, manual data entry into spreadsheets and subsequent verification is time-consuming, tedious, and prone to data errors. Traditionally, paper-based case report forms or questionnaires have been used for collecting data as a part of clinical practice, research studies, and quality control exercises. We also describe simple steps involved in designing a registry/clinical study in DADOS P, an open source EDC system to demonstrate the simplicity of using EDC systems. It will also facilitate their decision and subsequent adoption of EDC systems. This information will help orthopaedic surgeons make a balanced evaluation against the backdrop of their requirements and goals. The purpose of this article is to provide a brief overview of EDC systems, their types, and related pros and cons, as well as to describe commonly used EDC platforms and their features. Both commercial and open source EDC systems have a variety of features and have their own pros and cons which is a cause of frequent confusion and indecision. Apart from the difference in features, cost for access, support and maintenance form the major difference between the two categories. Due to these benefits, EDC systems are encouraged in clinical studies and trials.īased on the development and distribution model followed, EDC systems fall into commercial and open source categories. They have also been found to be more efficacious than paper based systems in clinical trials in terms of trial duration, number of queries and time to locked database. ![]() Electronic data capture (EDC) systems, in addition to addressing these limitations, reduce a substantial amount of workload, time, and cost, as well as enhance the quality of data collected. Although simple and inexpensive, they are not suitable for large registries and clinical trials as they are not secure, customizable, and accessible to geographically distributed users. Methods such as paper-based case report forms and direct data entry into spreadsheets and offline relational databases have long been utilized for this purpose. Planned and structured data collection aligning with their routine workflow can enable orthopaedic surgeons to explore a multitude of research questions. For example, collecting data on all the patients undergoing total knee arthroplasty can assist in evaluating effectiveness of different surgical techniques yet, such activities are less prevalent among orthopaedic surgeons. These clinical ideas and dilemmas form the other end of the channel-“bedside to benchtop.”Ī review of previous literature indicates that data collected in parallel to routine medical practice can be used to answer clinical questions. Experience and expertise also provide insights on possible alternatives to practice guidelines. These dilemmas are usually related to choice of treatment, medical versus surgical management, patient outcomes, care quality, and drug resistance, to name a few. Orthopaedic surgeons routinely face critical questions and dilemmas in their clinical practice. Although drug discovery forms a major part of continuing efforts to achieve better health care, effectiveness and practice variations are more practical and equally important topics. The transition from benchtop to bedside has long been a point of discussion and exploration in biomedical research.
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