Electronic Data Capture-clinical Trials Software

By Author: Ragalahari
Total Articles: 4
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The advent of EDC systems has not only made easier to capture data remotely from various sites but also with inbuilt validation and edit checks it has made possible to collect error free data in the very first stage. All this has helped in reducing the total time in getting 100% clean data, the data analyses and reporting and final submission to the regulatory agencies. Today we have many different types of electronic data capture solutions and may different vendors. These solutions have made the data capture and analysis accurate and easy to great extent, however if we look into another side, it has also resulted in so many variations in the data collection modules, namely the electronic case report forms (eCRF's). There are now hundreds of variations in the CRF design that basically capture the same information. Equally there are thousands of different naming conventions of the data filed on these eCRF's and mapping to the internal database.
Moreover, these EDC systems could be integrated ...
... with other data capture systems like IVRS and eDiary, which in turn have their own data formats and naming convention. To eliminate this ambiguity the CDISC has come up with the new initiative named Clinical Data Acquisition Standards Harmonization (CDASH). The goal of this initiative is to describe recommended basic standards for the collection of clinical trial data in EDC trials . CDASH moves upstream in the data-flow and identifies a basic set of highly recommended/conditional data collection fields that are expected to be present on the majority of CRFs. Following quote from Good Clinical Data Management Practices summarizes the need for it:
"There is arguably no more important document than the instrument that is used to acquire the data from the clinical trial, with the exception of the protocol, which specifies the conduct of that trial. The quality of the data collected relies first and foremost on the quality of that instrument. No matter how much time and effort go into conducting the trial, if the correct data points were not collected, a meaningful analysis may not be possible. It follows, therefore, that the design, development and quality assurance of such an instrument must be given the utmost attention."
With the new standards being defined, it becomes a challenging task to the clinical data management departments of the trial sponsors or a CRO to change, metamorphose and evolve with these standards. Especially from CRO perspective this would involve not only the right EDC and data management tools to conduct and manage the trials but also work with sponsors in helping them to develop and conduct the EDC trials as per these standards. Of course, these CDSIC standards will be evolving further and go through many version changes as new scenarios come up. In the end one common standard will result in streamlining the drug development and clinical trial process across the globe and eventually the complete harmonization and effortless streamlining of Medical research. As the demand for EDC software has raised, the concern now is in selecting the correct system that is effective, efficient and intuitive to the end user in enabling all the data that is to be integrated.

Short review on electronic data capture system written by a professional of MakroCare. Makrocare is now coming up with proven clinical tools like mEDC and more for Clinical trials and data management.