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Clinical Research Data Management
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DCU’s data management services include:
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CRF Development and Testing
The DCU contracts with professional printing companies to create CRF books that are shipped
to participating sites. Although the goal of web-based systems is a paperless system, it is important to provide
the sites with options of paper CRFs and standardized source documentation procedures. In addition to printed casebooks,
the DCU provides a set of CRFs in the CRF library which can be downloaded
as pdf files and printed at the site.
Subject Registration and Randomization
All commonly used randomization schemes are available for subject randomization, such as permuted block,
biased code, urn method, and adaptive randomization. The DCU subject registration and randomization website provides
services for multiple projects with project-limited user data access control.
Both subject registration and randomization system is linked to the entire DCU informatics infrastructure. Before
the randomization of a subject, the records for the site attempting to randomize are checked in the DCU Regulatory
Database, and randomization is only permitted if all site regulatory documents are in good standing. This structure
enables access to related data from all areas of the trial management process including study enrollment,
study calendar and CRF completion. This also allows for instantaneous access to real-time reports on the ongoing
status of any trial. Reports are blinded to treatment assignment and are password protected.
Data Collection and Data Verification
Once collected, the data is either single data entered or double data entered with verification of discrepant items
depending upon investigator preference. The data is validated though programmed logic checks, and data clarification
requests are generated as required.
In addition to the electronic validation process, studies may have monitors visit the sites on a specified basis.
The trained monitor has access to the database, the CRFs, and source documentation. One of DCU's information systems,
WebMonitor, is specially designed for site research staff and project monitors to retrieve the most up-to-date
information on the progress of studies, including subject status, CRF collection progress, data entry, data validation,
and data clarification request processing.
The percent of data checks is study specific; however, at a minimum monitors check 100% of adverse events and
informed consents and a minimum of 20% random sample of source documentation to database audits.
In addition to data management reports, the DCU provides investigators access to progress reports including
subject accrual status reports and subject study progress charts. These reports are study specific and are
designed to aid in project management.
The most critical part to the success of the web system is the training of the users. Users are trained
by the DCU data managers in utilizing the study information system. The importance of using
the system on a regular basis is stressed as it relates to the timeliness of data reporting.
Each site's use of the system is monitored by the data manager. Sites that are not timely on data collection
are notified and when necessary corrective action is taken by the study PI.
Informatics Infrastructure: Biomedical Information System
For more information, go to biomedical informatics page.
The DCU has substantial experience in accepting, converting, and delivering data in the most commonly used formats,
including SAS, SPSS, STATA, Structured Query Language (SQL) Server, Access, Excel, and FoxPro. Data files can be
copied onto a CD for transfer off site or can be electronically transferred via a secure study website,
as SSL encryption methods allow for secure internet transfer. A complete data dictionary, listing of all data
validation procedures (rules), and labels are included with data transfers for easy reference.
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