Database Development and Consultation
Research Support Services has broad experience and expertise in the area of data collection, management, and systems development. We can develop database systems for large research projects, or provide general consultation about planning, preparing, or analyzing your clinical research data.
Pre-Research Database Queries
Pre-research activity such as counting the number of patients with a certain diagnosis can be done to assist you in determining the feasibility of a project. We have knowledge of several databases at QMC from which data can be obtained. The largest database is the CLARITY database which supports the hospital-wide Care*Link system, but there are other departmental databases from which we can help you obtain data if needed.
Data Collection Plan
Some clinical research protocols contain a Data Collection Plan, and we can help you determine a specific plan, and the best data collection instruments for the scope of your project. A data collection plan should be brief but describe the major steps to collecting and preparing your data for analysis. Data fields should be described, and the data collection instrument should be attached to the protocol. Data collection instruments are usually a paper Case Report Form, screen-prints of an Electronic Data Collection System, or a combination of both.
Case Report Form Development
A Case Report Form (CRF) is a carefully organized set of forms designed to prompt the clinician to collect information in a structured consistent logical way. This is the preferred method of data collection in a small sized study, and we can assist you in the design. Usually one CRF is used for each patient, and the data can be transcribed into a computer at a later time for analysis. Using a CRF is error prone when it comes to the data transcription or data entry and most often warrants a formal error analysis to confirm the integrity of the information.
Electronic Data Collection System Development
An Electronic Data Collection (EDC) System is a computer based or a computer assisted system designed to capture information electronically. Most applications developed by us consist of a laptop computer with a custom database application designed to emulate the CRF and catch data entry errors at the same time. The system is portable and can be taken into medical records, patient bedside, or into the nurses' station to enter data from a patients chart, eliminating the need for CRF data transcription. Even though using an EDC system for direct input of data is less error prone than using a CRF, an error analysis should still be done.
Error Analysis
Error analysis is the random check of 5% of the data against the source documents. The checking process is usually well documented for proof of data integrity. If an error rate of more than 5% is found, further validation and error resolution must be done. We can provide the error analysis service given the source documents, but data cleaning beyond the 5% is the responsibility of the investigator.
For more information about data related services, research applications systems development, or data analyses and reporting, please contact:
Henry SweeneyManager, Research Support Services
1301 Punchbowl Street, UH Tower 619
Honolulu, Hawaii 96813
Phone: 808.537.7825
Fax: 808.547.4055
Email: hsweeney@queens.org