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There are few real controls in the administration of paper questionnaires for clinical trials, so there are data quality and protocol compliance risks at all sites at all times. |
As a consequence, using paper questionnaires to collect patient reported outcomes data results in hundreds or thousands of queries. High query volume not only suggests high data quality risk, but also introduces significant cost and time issues.
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On the other hand, assisTek’s Tablet and iPhone ePRO questionnaire systems for clinical trials have highly customized software logic and edit checks that provide a high degree of control and assurance of both protocol compliance and data quality.
Scoring is controlled programmatically and validated extensively reducing the many man hours needed to calculate the scores manually.
In recent assisTek clinical trials, e-questionnaire data is typically more than 99% complete. Queries are few, and only result from situations beyond system control. Speed to data access is another significant benefit of using assisTek or electronic systems instead of paper. Our clinical trial questionnaire systems enable sponsors to receive and analyze detailed results data throughout the trial.
In addition, we provide best of breed web-based reporting that enables study teams to easily monitor site status on a management level and take corrective action in real time.
Work and burden for site staff and the study management team are reduced significantly with our questionnaire systems for clinical trials. The burden of handling and managing activities related to literally thousands of sheets of paper by hundreds of people is eliminated, providing not only time and cost savings, but a valuable reduction in stress.
Security and attributability are also high value benefits of electronic data collection and our systems. All users of all of our systems, study team, site staff, and patients have passwords or PINs that are not known by others. This access control adds even further strength and credibility to the data.
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