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

Children's Oncology Group

Status: Active, not recruiting

Conditions: Accurate and Complete Data Acquisition for Clinical Trials

Treatments: Other: Medidata RAVE

Study type: Observational

Funder types: NETWORK; NIH

Identifiers

NCT05020951

PEPN21EHR

PCTC-N15 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 118 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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:

• PEP-CTN: ADVL1412, ADVL1312, ADVL1411
• PBTC: PBTC-042, PBTC-047 (Stratum 1), PBTC-050, PBTC-051 (Stratum 1)

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.

• Site Participation: Children's Healthcare of Atlanta - Scottish Rite and Egleston, Children's Hospital of Philadelphia, Memorial Sloan Kettering Cancer Center, Seattle Children's Hospital, St. Jude Children's Research Hospital, Texas Children's Hospital, and University of California, San Francisco - Mission Bay

Trial design

118 participants in 1 patient group

Laboratory Data

Description:

Electronic transfer of laboratory data from participating institutions' local electronic health records to the Medidata/RAVE

Treatment:

Other: Medidata RAVE