Postgraduate Students: Vladimír Arnot, Daniel Čapek, Rudolf Čejka, Dao Minh, Tomá Dulík, Martin Hrubý, Radek Kočí, Petr Kotásek, Marek Křejpský, Bohuslav Křena, Vladislav Kubíček, Vladimír Marek, Petr Matouek, Ale Mičín, Jiří Očenáek, Tomá Ondráček, Petr Peňás, Jaroslav Ráb, Richard Růička, Luká Sekanina, Ivan Schwarz, Azedien Sllame, Petr Smolík, Jiří Staroba, Josef Strnadel, Luká Szemla, Pavel Tinovský, Michal Tomů, Milan Urbáek, Michal Vojkůvka, Petr Vurm, Frantiek Zbořil

Electronic data capture - Narrowing the gap between clinical and data management.

Department of Computer Science and Engineering

Using e-technologies in clinical trials.

......................................................................................................................................... ii Preface ........................................................................................................................................... iii Table of

background

Pressures at the front lines : investigative sites and contract research organizations in Canadian clinical trials

Background: Electronic medical records and electronic data capture (EDC) have changed data collection in clinical and translational research. However, spreadsheet programs, such as Microsoft Excel, are still used as data repository to record and organize patient data for research. Objective: The objective of this study is to assess the efficiency of EDC as against a standard spreadsheet in regards to time to collect data and data accuracy, measured in number of errors after adjudication. Methods: This was a crossover study comparing the time to collect data in minutes between EDC and a spreadsheet. The EDC tool used was Research Electronic Data Capture (REDCap), whereas the spreadsheet was Microsoft Excel. The data collected was part of a registry of patients who underwent coronary computed tomography angiography in the emergency setting. Two data collectors with the same experience went over the same patients and collected relevant data on a case report form identical to the one used in our Emergency Department (ED) registry. Data collection tool was switched after the patient that represented half the cohort. For this, the patient cohort was exactly 30 days of our ED coronary Computed Tomography Angiography registry and the point of crossover was determined beforehand to be 15 days. We measured the number of patients admitted, and time to collect data. Accuracy was defined as absence of blank fields and errors, and was assessed by comparing data between data collectors and counting every time the data differed. Statistical analysis was made using paired t -test. Results: The study included 61 patients (122 observations) and 55 variables. The crossover occurred after the 30th patient. Mean time to collect data using EDC in minutes was 6.2±2.3, whereas using Excel was 8.0±2.0 (P <.001), a difference of 1.8 minutes between both means (22%). The cohort was evenly distributed with 3 admissions in the first half of the crossover and 4 in the second half. We saw 2 (<0.1%) continuous variable typos in the spreadsheet that a single data collector made. There were no blank fields. The data collection tools showed no differences in accuracy of data on comparison. Conclusions: Data collection for our registry with an EDC tool was faster than using a spreadsheet, which in turn allowed more efficient follow-up of cases. [J Med Internet Res 2016;18(6):e141]

Medical Registry Data Collection Efficiency: A Crossover Study Comparing Web-Based Electronic Data Capture and a Standard Spreadsheet.

There is an urgent need to expedite the time-to-market for new drugs and to make the approval process simpler But clinical trials are a complex process and the increased complexity leads to decreased efficiency Hence, pharmaceutical organizations want to move toward a more technology-driven clinical trial process for recording, analyzing, reporting, archiving, etc, In recent times, the progress has certainly been made in developing paperless systems that improve data capture and management The adaptation of paperless processes may require major changes to existing procedures But this is in the best interests of these organizations to remain competitive because a paperless clinical trial would lead to a consistent and streamlined framework Moreover, all major regulatory authorities also advocate adoption of paperless trial But challenges still remain toward implementation of paperless clinical trial process

Electronic data capture - Narrowing the gap between clinical and data management.

Citations

Department of Computer Science and Engineering

Using e-technologies in clinical trials.

Pressures at the front lines : investigative sites and contract research organizations in Canadian clinical trials

Medical Registry Data Collection Efficiency: A Crossover Study Comparing Web-Based Electronic Data Capture and a Standard Spreadsheet.

Paperless clinical trials: Myth or reality?