NCT05020951

Pilot Study to Enable Electronic Laboratory Data Transfer From Participating Institutions to MediData/RAVE

Pilot Study to Enable Electronic Laboratory Data Transfer Into Medidata Rave

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 118 (estimated)
• Sponsor: Children's Oncology Group · Network
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Accurate and Complete Data Acquisition for Clinical Trials

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-08-28
• Primary completion: 2023-07-31
• Completion: 2026-03-31
• First posted: 2021-08-25
• Last updated: 2026-01-07

Locations

8 sites across 1 country: United States