NCT Number: NCT05020951
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.
This study is active but is not currently recruiting participants.
Notify MeAll sexes
Observational
UCSF Medical Center-Mission Bay, San Francisco, California, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patient Data Inclusion Criteria: Specific patient clinical research data to be included in this study for retrospective data capture and analysis will originate from the following PEP-CTN and PBTC studies:
Participating Site Inclusion Criteria: Data from above clinical studies at the following institutions will be included in the initial pilot, with potential to expand to other sites at which patients on these studies were treated.
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.
Time frame: 18 months
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
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.
Children's Oncology Group
Network
Pilot Study to Enable Electronic Laboratory Data Transfer Into Medidata Rave
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
