An initial step toward more accurate and complete data acquisition for clinical trials, the Pediatric Early Phase Clinical Trials Network (PEP-CTN) and Pediatric Brain Tumor Consortium (PBTC) will assess the feasibility of electronic transfer of laboratory data from participating institutions' local electronic health records to the Medidata/RAVE that is housed within each consortium's Uniform Resource Locator (URL). This study will assess efficiency, effectiveness, and scalability of the laboratory data extraction and transfer processes. This study will identify factors in the process that impact consortium operations, central protocol activation and implementation to the point of declaring the site data-ready.
PRIMARY OBJECITVES I. To test the feasibility of implementing automated laboratory data extraction and data transfer tools at multiple sites within PEP-CTN and PBTC. SECONDARY OBJECTIVES I. To identify and evaluate discrepancies between laboratory data received through retrospective automated laboratory data extraction and manual data ascertainment during the original conduct of the study.
Study Type
OBSERVATIONAL
Enrollment
118
Data collection done exclusively through Medidata Rave. Medidata Rave is a clinical data management system being used for data collection for this trial/study. Access to the trial in Rave is controlled through the CTEP-IAM system and role assignments.
UCSF Medical Center-Mission Bay
San Francisco, California, United States
Children's Healthcare of Atlanta - Egleston
Atlanta, Georgia, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Saint Jude Children's Research Hospital
Memphis, Tennessee, United States
Texas Children's Hospital
Houston, Texas, United States
Seattle Children's Hospital
Seattle, Washington, United States
Test the frequency(%) of sites that successfully submitted implementing automated laboratory data extraction and data transfer tools at multiple sites within PEP-CTN and PBTC.
Thorough evaluation of the data extraction and transfer process from each participating site to the PBTC and PEP-CTN databases. Establish feasibility of the proposed process at each site as well as the operations cores.
Time frame: 18 months
Identify and evaluate discrepancies between laboratory data received through retrospective automated laboratory data extraction and manual data ascertainment during the original conduct of the study.
Laboratory results identified through automated extraction and transfer will be evaluated to determine if all laboratory results submitted as part of the therapeutic study can be identified.
Time frame: 18 months
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