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Software solutions for automatic bulk import of adverse event data, from existing clinical trial databases to the clinicaltrials.gov XML format, can dramatically streamline the basic results reporting process for clinical studies.
The first task of publishing a clinical study to the clinicaltrials.gov web site is the submission of the clinical study protocol registration data, after which the reporting of basic results becomes necessary. Basic results data for the clinical study should be reported on an ongoing basis, per the terms of registering clinical research trials with the FDA and CT.gov web site. Although reporting of basic results (which includes adverse events and SAEs) is a time-consuming data entry process, a streamlined software solution, via a bulk adverse event extraction and upload system, can greatly expedite and automate the process.
One of the more data-intensive and time-consuming aspects of reporting clinical trial basic results to clinicaltrials.gov includes the manual data entry of adverse event (AE) and serious adverse event (SAE) data into the required web site forms. While a single clinical trial adverse advent requires a limited number of fields when submitting to clinicaltrials.gov, clinical trials often register hundreds or more adverse event and serious adverse event incidents throughout a clinical study. As adverse event and serious adverse event incidents are required to be reported to the clinicaltrials.gov web site, a software solution for streamlining adverse event and serious adverse event reporting to clinicaltrials.gov becomes a necessity.
Basic results registration on clinicaltrials.gov can be streamlined through the use of a powerful software solution. Software can be used to bulk import adverse event and serious adverse event data from existing databases and data storage formats into the common clinicaltrials.gov XML format. Once adverse event and serious adverse event data has been automatically processed and converted to the clinicaltrials.gov XML, it may then be uploaded to the clinicaltrials.gov web site for automatic publishing.
Basic results data and adverse events may be automatically bulk imported and uploaded to clinicaltrials.gov via XML on an ongoing basis, successfully fulfilling the reporting requirements for this aspect of the clinical study. Differences in the backing database storage for AE adverse event and SAE serious adverse event data can be made compatible with the bulk import software to allow automated exporting of AE and SAE data for conversion to the clinicaltrials.gov XML format and bulk upload. This powerful process for data collection can streamline the AE and SAE basic results data submission process and facilitate bulk data adverse event uploads to clinicaltrials.gov.
