Data Capture and Management
Our researchers understand the critical importance of high-quality data systems and data management to the integrity and security of research data. Of equal consequence is the collaboration with the study investigators to ensure that all systems are easily usable by site staff and that the appropriate data are captured. We have more than 40 years of experience providing our clients with a full range of data capture and collection services, from one-on-one personal interviewing to leading-edge computer-assisted methodologies.
Electronic Data Capture
RTI has a long history of using electronic data capture (EDC) for collaborative research studies. We have developed tailored EDC systems for many research networks funded by the National Institutes of Health (NIH). RTI has adopted the Metadata Rave® system as our standard for EDC. The web-based Rave software uses the Internet to expedite clinical data collection at dispersed study sites. A single web-based user interface in the Rave system creates an easy-to-use environment for data capture, study management, reporting, and data query resolution. Rave also is 21 CFR Part 11 compliant for use with FDA-regulated clinical studies.
Patient-Reported Outcomes
RTI is an industry leader in the development and use of state-of-the-art software systems to improve the quality of patient-reported outcomes (PROs) where the patient or another person is the respondent. Examples are measurements of quality of life or pain, administration of psychometric scales, or reporting of behavioral risk factors. We have created several high-technology systems to facilitate the collection of patient-reported outcomes, including
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Computer-assisted personal interviewing (CAPI)
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Computer-assisted telephone interviewing (CATI)
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Audio computer-assisted self-interviewing (ACASI)
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IVR or telephone audio computer-assisted self-interviewing (T-ACASI)
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Computer-assisted recorded interviewing (CARI)
Self-interviewing systems greatly increase accuracy of the reporting of sensitive outcomes, such as risky sexual acts, intravenous drug use, abortions, and suicide ideation.
Ancillary Systems
In addition to data capture systems, we have also developed numerous other systems to support collaborative research networks, including
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Web portals that provide a proven and indispensable communication channel for the collaborators
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Biospecimen tracking systems to manage the collection, transportation, storage, annotation, and distribution of biospecimens
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Patient tracking systems used to maintain contact with and participation of patients in longitudinal or other multiyear studies
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Control systems that track events associated with study participants and study management activities
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Randomization tools to assign participants to a study arm based upon a randomization algorithm
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Medical device interfaces to import data from medical devices or laboratories
Data Security
We take data privacy and HIPAA regulations very seriously. All data collected on human participants or biospecimens are subject to the Privacy Act, HIPAA, and all other U.S. Department of Health and Human Services (DHHS) regulations. Subjects' names and other private health information, with rare exception, are not part of the central database held at RTI; all such identifying information typically resides with the clinical site where the subject is enrolled. For the rare studies where identification is necessary, the identifying information is stored under rigorous security control separately from all other data. In addition, role-based security measures are built into our data management system to protect data from unauthorized access. System use and data access are limited to authorized users whose access, views, and actions are controlled by a configurable set of rights based on their role in the study.
Contact us for more information
- Rick L. Williams
- Susan D. Pedrazzani