Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:30 PM
Study NCT ID:
NCT05020951
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-11-25
First Post:
2021-08-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pilot Study to Enable Electronic Laboratory Data Transfer From Participating Institutions to MediData/RAVE
Sponsor:
Children's Oncology Group
Organization:
Study Overview
Official Title:
Pilot Study to Enable Electronic Laboratory Data Transfer Into Medidata Rave
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| PCTC-N15 | OTHER | Pediatric Brain Tumor Consortium (PBTC) | View |