Pilot Study to Enable Electronic Laboratory Data Transfer From Participating Institutions to MediData/RAVE
NCT05020951 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 118
Last updated 2026-05-18
Summary
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.
Conditions
- Accurate and Complete Data Acquisition for Clinical Trials
Interventions
- OTHER
-
Medidata RAVE
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.
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Pediatric Brain Tumor Consortium
collaborator NETWORK -
Children's Oncology Group
lead NETWORK
Principal Investigators
-
Tamara Miller, MD, MSCE · Children's Healthcare of Atlanta/Emory University
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-08-28
- Primary Completion
- 2023-07-31
- Completion
- 2026-06-30
Countries
- United States
Study Locations
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