Electronic Data Capture, Clinical Trial Software

The advent of EDC systems is not only simple, remote data capture process from various locations, but also with built-in validation controls, allowed us to collect accurate data in a first step. All this has in reducing the total time is always 100% clean data, analyzed data and helped the coverage and the final presentation to the regulators. Today we have many different types of Electronic Data Capture solutions, different vendors. These solutionsThe gathering and analysis of data from highly accurate and easy when you look in a different page, has many variations in data collection forms, namely the electronic case report forms out (eCRF is). Meanwhile, there are hundreds of variations in CRF design to capture essentially the same information. Similarly, there are thousands of different naming conventions for data on these eCRF classified and assigned to the internal database.

In addition, these EDCSystems could be integrated with other data acquisition systems such as IVR and eDiary, which are in turn formed their own data and naming conventions. To eliminate this ambiguity has with the CDISC Clinical Data Acquisition new initiative called harmonizing rules come (CDASH). The purpose of this initiative is to recommend basic standards for the collection of data from clinical studies described in EDC studies. CDASH moves upstream, the flow of data and identifies a number of basic highRecommended / related data collection fields that are expected to present the majority of the CRF.

Data Collection Tools

The following quote from Good Clinical Practices management data summarizes the need for them:

"There is probably no more important document that the instrument to acquire data from the clinical trial, with the exception of the protocol, which is conducting the study, which indicates. The quality of data collected is based mainly on quality,Instrument. No matter how much time and effort go into conducting the study, if the right data points have not been collected, a meaningful analysis impossible. It follows that the guarantee conception, development and quality of such an instrument, great care must be given. "

Is defined with the new standards is a difficult task to change the management of clinical data section of the study sponsors or CROs, to transform themselves and with theseStandard. Especially from the point of view this would not only CRO EDC and the right data management tools to create and manage processes, but also working with sponsors to help develop and manage the EDC studies with these standards. Of course, this standard CDSIC developed and go through many changes, like the new version of scenarios. In the end, a common standard to simplify the process of drug development and clinical trials around the world and the resultFinally, the full harmonization and rationalization of medical research. As the demand for EDC software has increased the concern is now to choose the right system, that an effective, efficient and intuitive for the consumer, so that all data will be integrated.

Electronic Data Capture, Clinical Trial Software